Overview

This trial is active, not recruiting.

Condition vision disorders
Treatments vistakon marketed contact lens (test), competitor marketed contact lens (control)
Sponsor Vistakon
Start date September 2015
End date February 2016
Trial size 450 participants
Trial identifier NCT02595502, CR-5743

Summary

The purpose of this investigation is to evaluate the short-term, clinical performance of two silicone hydrogel daily disposable contact lenses.

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 (subject)
Primary purpose treatment
Arm
(Active Comparator)
Test/control/test using the Vistakon Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily disposable on both eyes for approximately one week each with no washout period in between lenses for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn.
vistakon marketed contact lens (test) senofilcon A
competitor marketed contact lens (control) delefilcon A
(Active Comparator)
Control/test/control using the Vistakon Marketed contact lens (test) and the Competitor Marketed contact lens (control). Lenses will be worn as daily disposable on both eyes for approximately one week each with no washout period in between lenses for total study duration of approximately three weeks per subject. Subjects are required to wear the lenses at least five days for at least eight hours per day worn.
vistakon marketed contact lens (test) senofilcon A
competitor marketed contact lens (control) delefilcon A

Primary Outcomes

Measure
Overall comfort
time frame: 1 Week

Secondary Outcomes

Measure
Overall comfort
time frame: Week 2 and Week 3

Eligibility Criteria

Male or female participants from 18 years up to 39 years old.

Inclusion Criteria: - The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. - The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. - The subject must be between (and including) 18 and 39 years of age. - The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study. - The subject must have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -0.50 to -6.00 Diopters (D) in each eye. - The subject must have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye. - The subject must have best corrected visual acuity of 20/25 or better in each eye. Exclusion Criteria: - Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued). - Any ocular or systemic allergies or diseases that may interfere with contact lens wear. - Any autoimmune disease or use of medication, which may interfere with contact lens wear. - Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. - Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.). - Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. - Any ocular infection. - Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. - Monovision, multi-focal, toric, or extended wear contact lens correction. - Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. - History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear. - Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.

Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Vistakon.