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Effects of NOV03 on the Tear Film | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Effects of NOV03 on the Tear Film

Effects of NOV03 on the Tear Film in Subjects With Dry Eye Disease

NCT05723770•Bausch & Lomb Incorporated

Summary

Determine the effect of a single instillation of NOV03 on the thickness and evaporation rate of the mucus-aqueous layer of the tear film

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Will be at least 18 years of age at the time of consent. 2. Able to provide written voluntary informed consent. 3. Have a subject-reported history of DED in both eyes for at least 6 months prior to Visit 1. 4. Have Tear film break-up time (TFBUT) ≤5 sec at Visit
•Have Ocular Surface Disease Index (OSDI) ≥25 at Visit 1.
•Have an unanesthetized Schirmer's Test I ≥5 mm at Visit 1.
•Have Meibomian Gland Dysfunction (MGD) defined as total MGD score ≥ 3 (secretion of 5 central glands on lower eyelid will be evaluated, each will be scored from 0-3; 0 = normal, 1 = thick/yellow, whitish, particulate 2 = paste; 3 = none/occluded; total score will range from 0-15) at Visit 1.
•Have a total corneal fluorescein staining score of ≥2 and ≤11 (i.e. sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute (NEI) scale at Visit 1.
•Have at least one eye that satisfies all criteria for 4-8 above at Visit 1.
•Is able to fix his/her gaze for a minute, i.e. can see the fixation target and with no nystagmus
•Is able and willing to follow instructions, including participation in all trial assessments and visits.

Exclusion Criteria

•1. Have any clinically significant ocular surface slit-lamp findings at Visit 1 and Visit 2 and/or in the opinion of the Investigator had any findings that may have interfered with trial parameters, including
•1. history of eye trauma
•2. history of Stevens-Johnson syndrome
•3. active blepharitis or lid margin inflammation
•4. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency).
•5. abnormal lid anatomy that caused incomplete eyelid closure
•6. abnormal cornea shape (keratoconus)
•7. corneal epithelial defect or significant confluent staining or filaments
•8. history of herpetic keratitis.
•9. has a pterygium in either eye.
+17 more criteria

Locations (1)

Site 101

Miami, Florida, United States

Key Dates

Start Date

August 14, 2023

Primary Completion Date

December 23, 2023

Completion Date

December 23, 2023

Last Updated

July 4, 2025

Enrollment

ACTUAL participants

Conditions

Dry Eye Disease (DED)

Interventions

instillation of NOV03

DRUG

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

View study

RECRUITINGPHASE4

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

NCT07396441

Juvenile Open Angle GlaucomaDry Eye Disease (DED)+3 more

View study

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 4, 2025Data 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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Effects of NOV03 on the Tear Film

Inclusion Criteria

Exclusion Criteria

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

Supplementary Kelulut Honey Therapy in Juvenile Open-Angle Glaucoma: Effects on IL-6, RNFL and Dry Eye

Role of Corneal Nerves in Dry Eye Disease

Moderate-to-Severe Dry Eye Disease Relief Using Acoltremon

Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT

A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye