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

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

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Drug: Blink® Tears eye drops; Drug: Investigational lipid eye drops

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32205
      • Vue Optical Boutique
    • Saint Augustine, Florida, United States, 32092
      • St. Johns Eye Associates, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must 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. Between 18 and 69 (inclusive) years of age at the time of screening.
4. Subjects must be habitual spherical soft contact lens wearers.
5. Subjects must achieve visual acuity of 20/30 or better in each eye with their habitual contact lenses.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

The subject must not:

1. Currently pregnant or breast-feeding.
2. Diabetes.
3. Any ocular or systemic allergies or disease which may interfere with the clinical trial (at the discretion of the investigator).
4. Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the discretion of the investigator).
5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
6. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK)
7. Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment.
8. History of binocular vision abnormality or strabismus.
9. 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.
10. 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)
11. Employees of investigational clinic (investigator, coordinator, and technician etc) or family members of an employee of the clinical site by self-report.
12. 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.
13. Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc.).
14. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.\ In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain should not participate in the study (Castor Oil, Polyoxyl 40 Hydrogenated Castor Oil, Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate, Purified Water).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test/Control; 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; Control Drops; Drug: Investigational lipid eye drops; Test Drops
Experimental: Control/Test; 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; Control Drops; Drug: Investigational lipid eye drops; Test Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Investigators: Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Actual): October 10, 2020
• Study Completion (Actual): October 10, 2020

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: CR-6371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes