Overview

This trial has been completed.

Condition refractive error
Treatments delefilcon a multifocal contact lenses, habitual multifocal contact lenses
Sponsor Alcon, a Novartis Company
Start date August 2016
End date November 2016
Trial size 170 participants
Trial identifier NCT02871375, CLE914-P001

Summary

The purpose of this study is to evaluate DAILIES TOTAL1 ® Multifocal (DTl MF) contact lenses in current multifocal contact lens wearers with symptoms of end of day discomfort compared to their habitual multifocal contact lens correction.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Other)
Delefilcon A multifocal contact lenses in Period 1, followed by subject's habitual multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
delefilcon a multifocal contact lenses DAILIES TOTAL1® multifocal
Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)
habitual multifocal contact lenses
Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality
(Other)
Subject's habitual multifocal contact lenses in Period 1, followed by delefilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 14 ± 3 days.
delefilcon a multifocal contact lenses DAILIES TOTAL1® multifocal
Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)
habitual multifocal contact lenses
Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality

Primary Outcomes

Measure
Binocular high contrast/high illumination (HC/HI) visual acuity (VA) at intermediate distance (80 cm)
time frame: Day 14, each product

Secondary Outcomes

Measure
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) score
time frame: Day 14, each product

Eligibility Criteria

Male or female participants from 40 years up to 65 years old.

Inclusion Criteria: - Must sign an informed consent document; - Current daily wearer of soft multifocal contact lenses for at least 6 months with symptoms of contact lens discomfort as defined by the prescreening Eligibility Questionnaire; - Requires a near spectacle add of +0.50 to +2.50 diopters (D) (inclusive); - Requires lenses within the power range of study lenses to be fitted; - Best corrected VA (BCVA) of 20/30 (0.2 logarithmic minimum angle of resolution [logMAR]) or better in each eye at distance; - Willing to wear study lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits; - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Any eye condition that contraindicates wearing contact lenses as determined by the Investigator; - Any use of medications for which contact lens wear could be contraindicated, as determined by the Investigator; - Monocular (only one eye functional) or fit with only 1 lens; - Fitted with monovision; - Prior refractive surgery (e.g., laser vision correction, photorefractive keratectomy, etc.); - History of herpetic keratitis, ocular surgery, or irregular cornea; - Currently wearing DT1 MF contact lenses; - Other protocol-defined exclusion criteria may apply.

Additional Information

Official title DAILIES TOTAL1® Multifocal Clinical Assessment in Challenging Patients
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Alcon Research.