Effects of NOV03 on the Tear Film

NCT05723770 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 922
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (2)

• Thickness of the Mucus-aqueous Tear Film Layer

  Thickness of the mucus-aqueous layer of the tear film, measured in nanometers

  over 4 hours following instillation of NOV03

• Thinning Rate of the Mucus-aqueous Tear Film Layer

  The rate of change in the thickness of the tear film mucus-aqueous layer, measured in nanometers/second

  over 4 hours following instillation of NOV03

Study Arms (1)

Perfluorohexyloctane

EXPERIMENTAL

Drug: instillation of NOV03

Interventions

instillation of NOV03 DRUG

This trial consists of 2 office visits over a period of approximately 2 weeks. At Visit 2, a designated clinical staff member or the investigator will instill 1 drop of NOV03 into each eye.

Perfluorohexyloctane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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
• history of eye trauma
• history of Stevens-Johnson syndrome
• active blepharitis or lid margin inflammation
• DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells (as with vitamin A deficiency).
• abnormal lid anatomy that caused incomplete eyelid closure
• abnormal cornea shape (keratoconus)
• corneal epithelial defect or significant confluent staining or filaments
• history of herpetic keratitis.
• has a pterygium in either eye.
• ocular or periocular rosacea that in the judgement of the Investigator interfered with the trial
• Has used any topical ocular steroids treatments, prescription dry eye therapy including varenicline nasal spray, or topical anti-glaucoma medication within 60 days prior to Visit 1.
• Have had a LipiFlow procedure, intense pulse light procedure or any kind of other procedure affecting meibomian glands within 6 months prior to Visit 2.
• Have received or removed a permanent punctum plug within 3 months (6 months for dissolvable punctum plugs) prior to Visit 2.
• Have used any eye drops (prescription or artificial tears) and/or TrueTearTM device (intranasal tear neurostimulator) within 24 hours before Visit 2.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Site 101

Miami, Florida, 33125, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

The study had substantial technical data collection issues that prevented many of the subjects' parameter scores from being saved and analyzed. In particular for the mucus-aqueous layer thickness thinning rate (MALTR) the number of study eyes for which measurements were collected ranged from 6-11 rather than the planned 30 study eyes. Analysis was conducted without imputation of data.Thus, results were inconclusive due to data collection issues and any representation of data would be misleading.

Results Point of Contact

• Title: Megan Cavet
• Organization: Bausch & Lomb

Megan.Cavet@bausch.com

5852849474

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This pilot, open label, single-arm, single-center study will consist of 2 study visits in subjects with dry eye disease associated with MGD. A Screening Visit will occur to verify subjects are eligible to participate followed by an Assessment Visit to evaluate tear film parameters at baseline and over approx. 4 hours following a single instillation of NOV03

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 13, 2023
• Study Start: August 14, 2023
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: July 4, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-07

Locations

US (1)