Overview

This trial is active, not recruiting.

Condition myopia
Treatments comfilcon a - contact lenses, samfilcon a - contact lenses
Sponsor Coopervision, Inc.
Start date August 2015
End date January 2016
Trial size 90 participants
Trial identifier NCT02542072, EX-MKTG-59 (VISA-406)

Summary

The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (subject)
Arm
(Active Comparator)
comfilcon A - contact lenses
comfilcon a - contact lenses
(Active Comparator)
samfilcon A - contact lenses
samfilcon a - contact lenses

Primary Outcomes

Measure
Overall comfort rating of comfilcon A lens wear
time frame: Up to 4 weeks
Overall comfort rating of samfilcon A lens wear
time frame: Up to 4 weeks
Insertion comfort rating of comfilcon A lens wear
time frame: Up to 4 weeks
Insertion comfort rating of samfilcon A lens wear
time frame: Up to 4 weeks
End of day comfort rating of comfilcon A lens wear
time frame: Up to 4 weeks
End of day comfort rating of samfilcon A lens wear
time frame: Up to 4 weeks
During the day comfort rating of comfilcon A lens wear
time frame: Up to 4 weeks
During the day comfort rating of samfilcon A lens wear
time frame: Up to 4 weeks
Overall comfort rating of habitual lens wear
time frame: Baseline
Insertion comfort rating of habitual lens wear
time frame: Up to 4 weeks
End of day comfort rating of habitual lens wear
time frame: Up to 4 weeks
Overall comfort rating of comfilcon A lens wear
time frame: 2 weeks to 4 weeks follow-up
Overall comfort rating of samfilcon A lens wear
time frame: 2 weeks to 4 weeks follow-up

Secondary Outcomes

Measure
Comfortable average wearing time of comfilcon A lens wear
time frame: Collected by text on Days, 3, 12, 26 at 8:00am, 12:00pm, 4:00pm, and 8:00pm
Comfortable average wearing time of samfilcon A lens wear
time frame: Collected by text on Days, 3, 12, 26 at 8:00am, 12:00pm, 4:00pm, and 8:00pm
Comfortable average wearing time comfilcon A lens wear
time frame: Baseline Visit, 2 weeks follow-up, 4 weeks follow- up
Comfortable average wearing time samfilcon A lens wear
time frame: Baseline Visit, 2 weeks follow-up, 4 weeks follow- up
Comfortable wearing time comfilcon A lens wear
time frame: Collected by text on Days, 3, 12, 26 at 8:00am, 12:00pm, 4:00pm, and 8:00pm
Comfortable wearing time samfilcon A lens wear
time frame: Collected by text on Days, 3, 12, 26 at 8:00am, 12:00pm, 4:00pm, and 8:00pm
Comfortable wearing time comfilcon A lens wear
time frame: Baseline Visit, 2 weeks follow-up, 4 weeks follow- up
Comfortable wearing time samfilcon A lens wear
time frame: Baseline Visit, 2 weeks follow-up, 4 weeks follow- up
Deterioration of comfortable wearing time comfilcon A lens wear
time frame: Baseline Visit, 2 weeks follow-up, 4 weeks follow- up
Deterioration of comfortable wearing time samfilcon A lens wear
time frame: Baseline Visit, 2 weeks follow-up, 4 weeks follow- up
Maximum wearing time of comfilcon A lens
time frame: Baseline Visit, 2 weeks follow-up, 4 weeks follow- up
Maximum wearing time of samfilcon A lens wear
time frame: Baseline Visit, 2 weeks follow-up, 4 weeks follow- up
Maximum wearing time of habitual lens wear
time frame: Baseline Visit, 2 weeks follow-up, 4 weeks follow- up
Vision quality of comfilcon A lens wear
time frame: 4 weeks Follow-up
Vision quality of samfilcon A lens wear
time frame: 4 weeks Follow-up
Overall lens handling of comfilcon A lenses
time frame: 4 weeks Follow-up
Overall lens handling of samfilcon A lenses
time frame: 4 weeks Follow-up
Overall lens fit acceptance of comfilcon A
time frame: 4 weeks Follow-up
Overall lens fit acceptance of samfilcon A
time frame: 4 weeks Follow-up
Lens fit of comfilcon A
time frame: Baseline Visit, 2 week follow-up (lens pair 2), 4 week follow-up
Lens fit of samfilcon A
time frame: Baseline Visit, 2 week follow-up (lens pair 2), 4 week follow-up
Biomicroscopy- limbal hyperemia - comfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4 week follow-up, Exit
Biomicroscopy- limbal hyperemia - samfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4 week follow-up, Exit
Biomicroscopy- limbal hyperemia - habitual lens wear
time frame: Baseline Visit
Biomicroscopy- bulbar hyperemia - comfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up, Exit
Biomicroscopy- bulbar hyperemia - samfilcon A lens wear
time frame: BBaseline Visit, 2 week follow-up, 4-week follow-up, Exit
Biomicroscopy- bulbar hyperemia - habitual lens wear
time frame: Baseline Visit
Biomicroscopy- palpebral hyperemia - comfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up, Exit
Biomicroscopy- palpebral hyperemia - samfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up, Exit
Biomicroscopy- palpebral hyperemia - habitual lens wear
time frame: Baseline Visit
Biomicroscopy - cornea staining comfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up, Exit
Biomicroscopy - cornea staining samfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up, Exit
Biomicroscopy - cornea staining habitual lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up, Exit
Biomicroscopy - conjunctival staining - comfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up, Exit
Biomicroscopy - conjunctival staining - samfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up, Exit
Biomicroscopy - conjunctival staining - habitual lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up, Exit
Lens Surface wetting - comfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up
Lens Surface wetting - samfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up
Front Surface film deposits - comfilcon A lens wear
time frame: 2 week follow-up, 4-week follow-up
Front Surface film deposits - samfilcon A lens wear wear
time frame: 2 week follow-up, 4-week follow-up
White spot deposits - comfilcon A lens wear
time frame: 2 week follow-up, 4-week follow-up
White spot deposits - samfilcon A lens wear
time frame: 2 week follow-up, 4-week follow-up
Rating of Vision: monocular distance Visual Acuity with Contact Lenses and Contact Lenses with Over-refraction comfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up
Rating of Vision: monocular distance Visual Acuity with Contact Lenses and Contact Lenses with Over-refraction samfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up
Rating of Vision: binocular distance Visual Acuity with Contact Lenses and Contact Lenses with Over-refraction comfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up
Rating of Vision: binocular distance Visual Acuity with Contact Lenses and Contact Lenses with Over-refraction samfilcon A lens wear
time frame: Baseline Visit, 2 week follow-up, 4-week follow-up
Visual acuity (VA) comfilcon A lens wear
time frame: Baseline Visit and Exit visits
Visual acuity (VA) samfilcon A lens wear
time frame: Baseline Visit and Exit visits
Distance VA - High Contrast comfilcon A lens
time frame: Baseline Visit, Dispense, 2 weeks follow-up, 4-weeks follow-up
Distance VA - High Contrast samfilcon A lens
time frame: Baseline Visit, Dispense, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Lens Centration comfilcon A lens
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Lens Centration samfilcon A lens
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Decentered Categorization - comfilcon A lens versus samfilcon A
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Decentered Categorization - samfilcon A lens versus samfilcon A
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Corneal Coverage - comfilcon A lens
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Corneal Coverage - samfilcon A
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Post-Blink Movement - comfilcon A lens wear
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Post-Blink Movement - samfilcon A lens wear
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Primary Gaze lag - comfilcon A lens
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Primary Gaze lag - samfilcon A lens
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Lens Tightness - Push-up test - comfilcon A lens
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator assessment of Lens Tightness - Push-up test - samfilcon A lens
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator subjective rating of Overall Fit Acceptance - comfilcon A lens
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Investigator subjective rating of Overall Fit Acceptance - samfilcon A lens
time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Preference of comfort - comfilcon A lenses versus habitual lenses
time frame: 2 week follow-up, 4 week follow-up
Preference of comfort - samfilcon A versus habitual lenses
time frame: 2 week follow-up, 4 week follow-up
Preference of dryness between comfilcon A lenses versus habitual lenses
time frame: 2 week follow-up, 4 week follow-up
Preference of dryness between samfilcon A lenses versus habitual lenses
time frame: 2 week follow-up, 4 week follow-up
Subjective response of Vision Correction currently used - Habitual
time frame: Baseline Visit
Subjective response of brand of contact lenses worn - Habitual
time frame: Baseline Visit
Subjective response of number of years worn - habitual contact lens use
time frame: Baseline Visit
Subjective response - problems handling - habitual contact lens use
time frame: Baseline Visit
Subjective response of how often currently wear lenses- habitual contact lens use
time frame: Baseline Visit
Subjective response of prescribed replacement schedule- habitual contact lens
time frame: Baseline Visit
Subjective response of eye discomfort during typical day- habitual contact lens
time frame: Baseline Visit
Subjective response of how usually wear contact lenses - habitual contact lens
time frame: Baseline Visit
Subjective response of how often experience eye related allergy symptoms - habitual contact lens
time frame: Baseline Visit
Subjective response regarding the sensitivity of eyes - habitual contact lens
time frame: Baseline Visit
Subjective response regarding previous optician/optometrist eye condition - habitual contact lens
time frame: Baseline Visit
Subjective response regarding inflammation or infection experience - habitual contact lens
time frame: Baseline Visit
Subjective response during typical day in the past 2 weeks frequency of eye discomfort during past 2 weeks - habitual contact lens
time frame: Baseline Visit
Subjective response during typical day in the past 2 weeks intensity when eyes have feeling of discomfort at the end of wearing time - habitual
time frame: Baseline Visit
Subjective response during typical day in the past 2 weeks frequency of eye dryness during past 2 weeks - habitual contact lens
time frame: Baseline Visit
Subjective response during typical day in the past 2 weeks of intensity when eyes have feeling of dryness at the end of wearing time - habitual
time frame: Baseline Visit
Subjective response during typical day in the past 2 weeks frequency of vision change between clear and blurry or foggy while wearing contact lenses - habitual contact lenses
time frame: Baseline Visit
Subjective response during typical day in the past 2 weeks of intensity when vision change between clear and blurry or foggy at the end of wearing time - habitual contact lenses
time frame: Baseline Visit
Subjective response during typical day in the past 2 weeks, frequency of eyes bothered so much wanted to close eyes - habitual contact lenses
time frame: Baseline Visit
Subjective response during typical day in the past 2 weeks frequency of eyes bothered so much while wearing contact lenses that felt the need to stop whatever doing and take out contact lenses - habitual contact lenses
time frame: Baseline Visit
Subjective response of comfort upon insertion - habitual contact lenses
time frame: Baseline Visit
Subjective response of comfort during a day's wear - habitual contact lenses
time frame: Baseline Visit
Subjective response of typical comfort just prior to removal - habitual contact lenses
time frame: Baseline Visit
Subjective response of dryness during a typical day of wear - habitual contact lenses
time frame: Baseline Visit
Subjective response of dryness prior to removal - habitual contact lenses
time frame: Baseline Visit
Subjective response of ease of insertion- habitual contact lenses
time frame: Baseline Visit
Subjective response of ease of removal - habitual contact lenses
time frame: Baseline Visit
Subjective response of overall vision quality- habitual contact lenses
time frame: Baseline Visit
Subjective response of comfort upon insertion - comfilcon A contact lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of comfort upon insertion - samfilcon A contact lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of overall comfort during a day's wear - comfilcon A contact lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of overall comfort during a day's wear - samfilcon A contact lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of typical comfort just prior to removal - comfilcon A contact lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of typical comfort just prior to removal - samfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of dryness during a typical day of wear - comfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of dryness during a typical day of wear - samfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of dryness prior to removal - comfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of dryness prior to removal - samfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of ease of insertion - comfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of ease of insertion - samfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of ease of removal - comfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of ease of removal - samfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of overall vision quality- comfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response of overall vision quality- samfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - at the end of the day forget wearing lenses because they feel so naturally comfortable - comfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - at the end of the day forget wearing lenses because they feel so naturally comfortable - samfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - compared to habitual lenses, study lenses provide same level of comfort at the end of the day as they do when I put them in -comfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - compared to habitual lenses, study lenses provide same level of comfort at the end of the day as they do when I put them in -samfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - study lenses are as comfortable at the end of the day as they are at the beginning - comfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - study lenses are as comfortable at the end of the day as they are at the beginning - samfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - study lenses are as comfortable now as they were on the first day of wear - comfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - study lenses are as comfortable now as they were on the first day of wear - samfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - study lenses are comfortable in dry environments - comfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - study lenses are comfortable in dry environments - samfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - comfortable at the end of the day so I don't have to take them out earlier than normally would - comfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - comfortable at the end of the day so I don't have to take them out earlier than normally would - samfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - feel as moist at the end of the day as at the beginning - comfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - feel as moist at the end of the day as at the beginning - samfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - eyes feel as moist now as they felt during the first day of wear - comfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - eyes feel as moist now as they felt during the first day of wear - samfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses wearing prevent my eyes from feeling dry - comfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses wearing prevent my eyes from feeling dry - samfilcon A lenses
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses help my eyes focus effortlessly when using digital devices (i.e. computer, smartphone, tablet) - comfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses help my eyes focus effortlessly when using digital devices (i.e. computer, smartphone, tablet) - samfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses help my eyes feel less tired at the end of the day even after long day of using computer or digital device - comfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses help my eyes feel less tired at the end of the day even after long day of using computer or digital device - samfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses help my eyes feel less dry at the end of the eay even after a long day of using a computer or digital device - comfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses help my eyes feel less dry at the end of the eay even after a long day of using a computer or digital device - samfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - at the end of the day I forget I am wearing my lenses - comfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - at the end of the day I forget I am wearing my lenses - samfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses that I am wearing provide clear vision - comfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses that I am wearing provide clear vision - samfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses definitely offer clear vision during driving - comfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - lenses definitely offer clear vision during driving - samfilcon A
time frame: 2 Week Follow-up, 4 Week Follow-up, 6 Week Follow-up, 8 Week Follow-up
Subjective response - preference of study lenses for being comfortable at the end of 2 weeks of wear - comfilcon A or samfilcon A
time frame: 6 Week Follow-up
Subjective response - preference of study lenses versus habitual giving same comfort after wearing for 2 weeks as the 1st day worn - comfilcon A or samfilcon A
time frame: 6 Week Follow-up
Subjective response - preference of comfort - 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of less dryness- 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of clear vision- 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of handling- 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of using digital devices- 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of lenses that provide all day natural comfort-- 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of lenses that let me enjoy all day comfort-- 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of study lenses compared to habitual prefer for comfort at the end of the day as they do at insertion - 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of study lens for comfort at the end of 4 weeks of wear - 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of study lens that provides same comfort after wearing for 4 weeks as the first day wore them - 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of study lens for being comfortable in dry environments - 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of study lens for helping focus effortless when using digital devices - 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of study lens for helping eyes feel less dry at the end of the day, even after long day of using computer, digital devices - 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of study lens for helping eyes feel less tired at the end of the day even after a long day of using computer, digital devices - - 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - preference of study lens for offering clear vision during driving- 1st Study Lens, 2nd Study Lens, No Preference
time frame: 8 Week Follow-up
Subjective response - contact lens care system used - habitual lenses
time frame: Baseline Visit
Subjective response - how usually wear contact lenses - habitual lenses
time frame: Baseline Visit

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion: - Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive) - Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens wearers. - Spectacle cylinder 0.75D in both eyes. - Correctable to 6/9 (20/30) in both eyes - Be between 18 and 50 years of age (inclusive) - Able to read, comprehend and sign an informed consent - Own a mobile phone and be willing to respond to Short Message Service (SMS) survey - Willing to comply with the wear and study visit schedule Exclusion: - Existing Biofinity or Ultra wearers - Any active corneal infection, injury or inflammation - Systemic or ocular allergies, which might interfere with Contact Lens wear - Systemic disease, which might interfere with Contact Lens wear - Ocular disease, which might interfere with Contact Lens wear - Strabismus or amblyopia - Subjects who have undergone corneal refractive surgery - Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear - Pregnant or lactating - Use of systemic/topical medication contraindicating Contact Lens wear - Diabetic - Site employees or family members of site employees

Additional Information

Official title Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
Principal investigator Graeme Young
Description This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Coopervision, Inc..