NCT02886923CompletedNot Applicable
Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens
Johnson & Johnson Vision Care, Inc.2 sites in 1 country24 target enrollmentStarted: August 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets.
Study Overview
Brief Summary
Subjects will wear 2 of 2 study contact lenses for a wearing time of approximately three to four hours at each of the visits in order to take measurements on binocular functional visual performance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 35 Years to 42 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 35 and 42 years of age (inclusive).
- •The subject's vertex corrected spherical equivalent distance refraction must be in the range of -6.00 Diopters (D) to +4.00 D in each eye.
- •The subject's refractive cylinder must be ≤ 0.75 D in each eye.
- •The subject must have best corrected visual acuity of 20/30 or better in each eye.
- •The subject must be an adapted soft contact lens wearer in both eyes (defined as a minimum of 6 hours of Daily Wear (DW) for a minimum of 1 month prior to the study).
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
Exclusion Criteria
- •Currently pregnant or lactating (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 infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self-report.
- •Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- •Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- •Any ocular infection.
- •Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.
- •Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
- •Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Outcomes
Primary Outcomes
The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets.
Time Frame: 15 minutes post lens fit
Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 250 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.
Secondary Outcomes
- The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets.(15 Minutes post lens fitting)
- The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets.(15 Minutes post lens fitting)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Unknown
Not Applicable
Changes of Visual Function, Ocular Surface Structures and Physiology After Long-Termed Contact Lens WearOcular Surface DiseaseIrregular AstigmatismKeratoconusNCT02894489National Taiwan University Hospital40
Completed
Not Applicable
Three Daily Wear Monthly Replacement Silicone Hydrogel Contact Lenses With Two Multi-purpose Disinfecting Solution CombinationsRefractive ErrorsNCT04789382Alcon Research36
Completed
Not Applicable
Safety and Efficacy of 2 Concentrations of Lubricin vs Sodium Hyaluronate in Ocular Discomfort After Refractive Surgery.Ocular DiscomfortNCT03031327Dompé Farmaceutici S.p.A30
Completed
Phase 2
Prolongation of Contact Lens Comfortable Wear Duration by CLM2 Topical GelContact Lens DiscomfortContact Lens-induced Corneal DisorderContact Lens Acute Red EyeContact Lens-induced Corneal Fluorescein StainingNCT03994406Glia, LLC30
Completed
Not Applicable
Effect of the Pigment-free Optical Zone Diameter of Decorative Tinted Soft Contact Lenses on Visual FunctionTinted Contact LenseNCT02537275Yonsei University30