N/A
N=23
Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens
Refractive Error
Bottom Line
View on ClinicalTrials.gov: NCT02886923 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: 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. — -0.03; 0.33 -10 x logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hioxifilcon A Test (Device); Hioxifilcon A With Cosmetic Ring Control (Device)
- Age
- Adult · 35+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-0.03; 0.33 | — |
| SECONDARY The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets. |
-2.16; -1.69 | — |
| SECONDARY The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets. |
-1.29; -1.04 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02886923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.