Loading clinical trials...

Evaluation of Multifocal Contact Lens Designs With and Without an HEV Blocker on Visual Function | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of Multifocal Contact Lens Designs With and Without an HEV Blocker on Visual Function

NCT04995055•Johnson & Johnson Vision Care, Inc.

View on ClinicalTrials.gov

Summary

This is a single-masked, bilateral, controlled, randomized, 2x2 crossover, non-dispensing clinical trial to characterize the effects of an HEV-Blocker on several measures of visual function in a presbyopic population.

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Potential subjects must satisfy all of the following criteria to be enrolled in the study:
•1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
•2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
•3. Be between at least 40 and not more than 70 years of age at the time of screening.
•4. Possess a wearable pair of spectacles that provide correction for distance vision.
•5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration).
•6. Be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
•7. The subject must have normal color perception as evidenced by reading 17 out of the first 21 Ishihara plates correctly.
•8. The subject's distance spherical equivalent of their refraction must be in the range of -1.00 D to -4.00 D.
•9. The subject's refractive cylinder must be ≤0.75 D in each eye.
+2 more criteria

Exclusion Criteria

•Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•1. Be currently pregnant or lactating.
•2. Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
•3. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoids, oral tetracyclines, oral phenothiazines, anticholinergics, oral/inhaled steroids, oral phosphodiesterase type 5 inhibitors, interferon alfa, antimycobacterial antibiotics, and nitroimidazole antibiotics. See Section 9.1 for additional details regarding excluded systemic medications.
•4. Any current use of ocular medication with the exception of rewetting drops.
•5. Any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein.
•6. Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK dacryocystorhinostomy, cataract surgery, retinal surgery, peripheral iridotomy/iridectomy, etc.).
•7. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
•8. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
•9. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
+6 more criteria

Locations (1)

University of Georgia

Athens, Georgia, United States

Key Dates

Start Date

October 25, 2021

Primary Completion Date

April 14, 2022

Completion Date

April 14, 2022

Last Updated

June 6, 2023

Enrollment

ACTUAL participants

Conditions

Visual Acuity

Interventions

JJVC Investigational Multifocal Contact Lens TEST Lens

DEVICE

ACUVUE® OASYS Multifocal

DEVICE

Effect of Action Video Games and Stroboscopic Glasses on Dynamic Visual Acuity.

NCT05956938

Visual Acuity

View study

COMPLETEDNA

Evaluating ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management

NCT05634408

Visual Acuity

View study

NOT_YET_RECRUITING

Assessing the Turkish DDIVAT for Visual Acuity Measurement

NCT07240480

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluation of Multifocal Contact Lens Designs With and Without an HEV Blocker on Visual Function

Inclusion Criteria

Exclusion Criteria

Effect of Action Video Games and Stroboscopic Glasses on Dynamic Visual Acuity.

Evaluating ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management

Assessing the Turkish DDIVAT for Visual Acuity Measurement

Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements

Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

Project ICOPE Brazil: Assessment of Intrinsic Capacity in Brazilian Older Adults