Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of Investigational Lubricating Eye Drops

NCT05814367 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CR-6503
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

This will be a single-visit, multi-site, randomized, single-masked, bilateral, active-controlled, non-dispensing, 2X2 crossover study.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Monocular logMAR Visual Acuity

  Monocular visual acuity was measured at distance (4meter) using a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast lighting conditions. VA was assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual acuity score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

  10 Minutes Post Eye Drop Administration

Study Arms (2)

Test/Control

EXPERIMENTAL

Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (test then control). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated.

Drug: Blink® Tears eye drops in a multidose bottle; Drug: Preservative-free investigational lubricating eye drops in a Novelia® eyedropper

Control/Test

EXPERIMENTAL

Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (control then test). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated.

Drug: Blink® Tears eye drops in a multidose bottle; Drug: Preservative-free investigational lubricating eye drops in a Novelia® eyedropper

Interventions

Blink® Tears eye drops in a multidose bottle DRUG

Control

Control/Test; Test/Control

Preservative-free investigational lubricating eye drops in a Novelia® eyedropper DRUG

Test

Control/Test; Test/Control

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• The subject must:
• Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Be between 18 and 69 (inclusive) years of age at the time of screening.
• By self-report, habitually wear soft spherical contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e., not extended wear modality). Habitual wear is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the last 30 days.
• Subjects must achieve visual acuity of 20/30 or better in each eye, with their habitual contact lenses.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• The subject must not:
• Be currently pregnant or lactating.
• Be diabetic.
• Be currently using any ocular medications or have any ocular infection of any type which may interfere with the clinical trial (at the investigator's discretion).
• By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with the clinical trial, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
• Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 3 months.
• Have participated in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment.
• Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
• Be a current habitual user of prescription medication to treat dry eye and ocular discomfort, ocular steroids, or any medication (RX or OTC) except artificial tears, that would interfere with the clinical study (at the discretion of the investigator).
• Have any known allergy or sensitivity to ingredients that the investigational product may contain (e.g., Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate and Purified Water).
• Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities, or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate participation or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
• Have a history of strabismus or amblyopia.
• Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, cataract removal, retinal laser photocoagulation, etc.).
• Have any significant corneal distortion due to previous contact lens wear, surgery, or pathology (At the discretion of the investigator).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (3)

VRC

Jacksonville, Florida, 32256, United States

Location

Maitland Vision Center - North Orlando Ave

Maitland, Florida, 32751, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Results Point of Contact

• Title: Nabin Joshi
• Organization: Johnson & Johnson Vision Care, Inc. (JJVC)

njoshi30@its.jnj.com

1-800-843-2020

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: April 6, 2023
• Primary Completion: May 6, 2023
• Study Completion: May 6, 2023
• Last Updated: April 27, 2025
• Results First Posted: May 28, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)