Overview

This trial is active, not recruiting.

Condition myopia
Treatments senofilcon a, stenfilcon a
Phase phase 4
Sponsor Coopervision, Inc.
Start date December 2015
End date March 2016
Trial size 70 participants
Trial identifier NCT02643004, EX-MKTG-62

Summary

The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Study participants are randomized to wear Senofilcon A or Stenfilcon A pair of study lenses then crossover to the alternate pair.
senofilcon a
contact lens
stenfilcon a
contact lens
(Active Comparator)
Study participants are randomized to wear Senofilcon A or Stenfilcon A pair of study lenses then crossover to the alternate pair.
senofilcon a
contact lens
stenfilcon a
contact lens

Primary Outcomes

Measure
Ocular Physiology, corneal staining - senofilcon A and stenfilcon A
time frame: Up to 1 week
Ocular Physiology, conjunctival and limbal redness - senofilcon A and stenfilcon A
time frame: Up to 1 week
Ocular Physiology, conjunctival staining - senofilcon A and stenfilcon A
time frame: Up to 1 week
Subjective response - overall - senofilcon A and stenfilcon A
time frame: Up to 1 week
Subjective response - comfort - senofilcon A and stenfilcon A
time frame: Up to 1 week
Subjective response - dryness- senofilcon A and stenfilcon A
time frame: Up to 1 week
Subjective response - vision - senofilcon A and stenfilcon A
time frame: Up to 1 week

Secondary Outcomes

Measure
Lens fit, centration - senofilcon A
time frame: Baseline
Lens fit, centration - senofilcon A
time frame: 1 week
Lens fit, movement- senofilcon A
time frame: Baseline
Lens fit, movement- senofilcon A
time frame: 1 week
Lens fit, centration - stenfilcon A
time frame: Baseline
Lens fit, centration - stenfilcon A
time frame: 1 week
Lens fit, movement - stenfilcon A
time frame: Baseline
Lens fit, movement - stenfilcon A
time frame: 1 week
Lens Surface - senofilcon A
time frame: Baseline
Lens Surface - senofilcon A
time frame: 1 week
Lens Surface - stenfilcon A
time frame: baseline
Lens Surface - stenfilcon A
time frame: 1 week
Visual Acuity - senofilcon A
time frame: baseline
Visual Acuity - senofilcon A
time frame: 1 Week
Visual Acuity - stenfilcon A
time frame: baseline
Visual Acuity - stenfilcon A
time frame: 1 Week

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria Subjects will only be eligible for the study if: - They are of legal age (18) and capacity to volunteer. - They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. - They are willing and able to follow the protocol. - They agree not to participate in other clinical research for the duration of this study. - They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive) - They have a spectacle cylindrical correction of -0.75D or less in each eye. - At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range. - They currently use soft contact lenses or have done so in the previous six months. - They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day). Exclusion criteria Subjects will not be eligible to take part in the study if: - They have an ocular disorder which would normally contra-indicate contact lens wear. - They have a systemic disorder which would normally contra-indicate contact lens wear. - They are using any topical medication such as eye drops or ointment. - They have had cataract surgery. - They have had corneal refractive surgery. - They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. - They are pregnant or lactating. - They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. - They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction. - They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study. - They currently wear either MyDay (daily) or the Acuvue Oasys (2 weekly) lens.

Additional Information

Official title The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses
Principal investigator Carole Maldonado-Codinal, PhD
Description The purpose of this bilateral cross-over study is to evaluate the clinical performance of senofilcon A lens with the stenfilcon A lens. In particular, the study will focus on ocular physiology, lens fit, lens surface, visual acuity, and subjective response.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Coopervision, Inc..