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Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients | Clinical Trials | Clareo Health

COMPLETED

Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients

NCT03995355•Johnson & Johnson Vision Care, Inc.

View on ClinicalTrials.gov

Summary

This is a double-masked, randomized, bilateral, 2-Arm parallel group study. Subjects are scheduled for 3 study visits (screening/baseline, 7-Day and 30-Day follow-up visits) over a period of one month.

Eligibility

Age

18 - 69 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Potential subjects must satisfy all the following criteria to be enrolled in the study:
•1. Subjects must be at least 18 years of age and no more than 69 years of age (inclusive).
•2. Subjects must be non-contact lens wearers.
•3. Subjects must achieve visual acuity of 20/30 or better in each eye, either unaided or best corrected.
•4. Subjects must possess a functional/usable pair of spectacles and bring them to every visit (only if applicable - to the investigators discretion).
•5. Self-reported symptoms of ocular dryness or irritation and/or the use of artificial tears in the last 3 months.
•6. Subjects must read, understand, and sign the Statement of Informed Consent.
•7. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria

•Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•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 investigator's discretion).
•4. Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the investigator's discretion).
•5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
•6. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA scale.
•7. Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc.).
•8. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology.
•9. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK).
+6 more criteria

Locations (1)

Premier Vision

Amarillo, Texas, United States

Key Dates

Start Date

June 26, 2019

Primary Completion Date

September 20, 2019

Completion Date

September 20, 2019

Last Updated

July 3, 2023

Enrollment

161

ACTUAL participants

Conditions

Visual Acuity

Interventions

9618X investigational lipid eye drops

DEVICE

Blink® Tears

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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: July 3, 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.

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Clinical Evaluation of an Investigational Lipid Drop in Non-contact Lens Wearing Patients

Inclusion Criteria

Exclusion Criteria

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

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