Effects of NOV03 on the Tear Film

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

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: instillation of NOV03

Detailed Description

Characterize the effect of a single instillation of NOV03 on the lipid layer of the tear film

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • Site 101

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

General/Ocular 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:

General/Ocular 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.
   10. ocular or periocular rosacea that in the judgement of the Investigator interfered with the trial
2. 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.
3. 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.
4. Have received or removed a permanent punctum plug within 3 months (6 months for dissolvable punctum plugs) prior to Visit 2.
5. Have used any eye drops (prescription or artificial tears) and/or TrueTearTM device (intranasal tear neurostimulator) within 24 hours before Visit 2.
6. Have active ocular allergies or ocular allergies that are expected to be active during the trial period.
7. Have worn contact lenses within 1 month of Visit 1 or anticipate using contact lenses during the trial.
8. Have undergone intraocular surgery or ocular laser surgery within the previous 6 months or had any planned ocular and/or lid surgeries over the trial period.
9. Have an active ocular or systemic infection (bacterial, viral, or fungal), including fever requiring treatment with antibiotics.
10. Is a woman who was pregnant, nursing or planning a pregnancy.
11. Is a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception included: hormonal (oral, implantable, injectable, or transdermal contraceptives); mechanical (spermicide in conjunction with a barrier such as a diaphragm or condom); intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence could have been regarded as an adequate method of birth control; however, if the subject becomes sexually active during the trial, she must agree to use adequate birth control as defined above for the remainder of the trial.
12. Has an uncontrolled systemic disease in the opinion of the Investigator will interfere with the trial.
13. Has a known allergy and/or sensitivity to the investigational drug.
14. Has used any oral medications known to cause ocular drying (e.g., antihistamines, antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is expected to be unstable during the trial.
15. Have taken isotretinoin (e.g. Accutane, Myorisan, Claravis, Amnesteem) within 6 months of Visit 1.
16. Has corrected VA worse than or equal to logarithm of the minimum angle of resolution (LogMAR), +0.7 as assessed with Early Treatment Diabetic Retinopathy Study (ETDRS) charts in both eyes at Visit 1.
17. Is currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days of Visit 2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Perfluorohexyloctane	Drug: instillation of NOV03; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2023
• Primary Completion (Actual): December 23, 2023
• Study Completion (Actual): December 23, 2023

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Corneal Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: 922

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No