Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of a Lipid- Based Lubricating Eye Drop

NCT06131476 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CR-6371
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

This is a single visit, randomized, double masked, bilateral, non-dispensing, 2×2 crossover study to assess visual acuity.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Visual Acuity (logMAR) at 3 Minutes Post Instillation

  High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.

  3 minutes post instillation

• Visual Acuity (logMAR) at 10 Minutes Post Instillation

  High contrast bright illumination monocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicate better vision. The average logMAR visual acuity for each treatment was reported.

  10 minutes post instillation

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 the TEST lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the CONTROL lubricating eye drops will be instilled.

Drug: Blink® Tears eye drops; Drug: Investigational lipid eye drops

Control/Test

EXPERIMENTAL

Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive the CONTROL lubricating eye drops, with a washout period of 90 minutes between instillations. After the wash-out period, the TEST lubricating eye drops will be instilled.

Drug: Blink® Tears eye drops; Drug: Investigational lipid eye drops

Interventions

Blink® Tears eye drops DRUG

Control Drops

Control/Test; Test/Control

Investigational lipid eye drops DRUG

Test Drops

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.
• Between 18 and 69 (inclusive) years of age at the time of screening.
• Subjects must be habitual spherical soft contact lens wearers.
• 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:
• Currently pregnant or breast-feeding.
• Diabetes.
• Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the discretion of the investigator).
• Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the discretion of the investigator).
• Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
• History of any ocular or corneal surgery (e.g. RK, PRK, LASIK)
• Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment.
• History of binocular vision abnormality or strabismus.
• Habitual wearers of rigid gas permeable lens within the past 3 months5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
• Current habitual use of Prescription Medication to treat dry eye or ocular discomfort, ocular steroids, or any medication (RX or OTC) that would interfere with the clinical study (at the discretion of the investigator)
• Employees of investigational clinic (investigator, coordinator, and technician etc) or family members of an employee of the clinical site by self-report.
• Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, cornea vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale.
• Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc.).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (2)

Vue Optical Boutique

Jacksonville, Florida, 32205, United States

Location

St. Johns Eye Associates, P.A.

Saint Augustine, Florida, 32092, United States

Location

Results Point of Contact

• Title: Principal Research Optometrist, Clinical Sciences
• Organization: Johnson & Johnson Vision Care

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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: September 16, 2020
• Primary Completion: October 10, 2020
• Study Completion: October 10, 2020
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

US (2)