Dry Eye Disease (DED)Phase 4NCT05723770

Effects of NOV03 on the Tear Film

A Phase 4 study testing instillation of NOV03 in people with Dry Eye Disease (DED), run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Disease (DED)
What is being tested?: instillation of NOV03
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 14 Aug 2023to 23 Dec 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

General/Ocular Exclusion Criteria
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).

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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.
Have active ocular allergies or ocular allergies that are expected to be active during the trial period.
Have worn contact lenses within 1 month of Visit 1 or anticipate using contact lenses during the trial.
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.
Have an active ocular or systemic infection (bacterial, viral, or fungal), including fever requiring treatment with antibiotics.
Is a woman who was pregnant, nursing or planning a pregnancy.
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.
Has an uncontrolled systemic disease in the opinion of the Investigator will interfere with the trial.
Has a known allergy and/or sensitivity to the investigational drug.
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.
Have taken isotretinoin (e.g. Accutane, Myorisan, Claravis, Amnesteem) within 6 months of Visit 1.
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.
Is currently enrolled in an investigational drug or device study or had used an investigational drug or device within 60 days of Visit 2.

Trial locations and contacts

1 site in 1 country.

United States1 site

Site 101
Miami, Florida, 33125

Other trials in United States

About this study

Official title: 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

Conditions: Dry Eye Disease (DED)
Being tested: instillation of NOV03
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

instillation of NOV03Drug
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.

Study groups in NCT05723770
Study group	Role	What they receive
Perfluorohexyloctane	Experimental	Not described Receives: Drug: instillation of NOV03

What is being measured

The primary outcome is the main question the study is designed to answer.

Thickness of the Mucus-aqueous Tear Film Layer
Thickness of the mucus-aqueous layer of the tear film, measured in nanometers
Measured: 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
Measured: over 4 hours following instillation of NOV03

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 202323 Dec 2023

First posted13 Feb 2023
Study start14 Aug 2023
Primary completion23 Dec 2023
Study completion23 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: 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
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05723770
Sponsor's protocol ID: 922
Status last verified: Jul 2025
First submitted: 19 Jan 2023
Last updated: 4 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Disease (DED) trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of NOV03 on the Tear Film in Subjects With Dry Eye Disease
ClinicalTrials.gov ID: NCT05723770
Acronym / sponsor ID: 922
Conditions: Dry Eye Disease (DED)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 14 Aug 2023 (actual)
Primary completion: 23 Dec 2023 (actual)
Study completion: 23 Dec 2023 (actual)
First posted: 13 Feb 2023 (actual)
Results: Posted 4 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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

Arm	Type	Receives
Perfluorohexyloctane	Experimental	Drug: instillation of NOV03

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (28 listed)

General/Ocular Exclusion Criteria
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
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
instillation of NOV03This 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.	Drug	Perfluorohexyloctane

Primary outcome

Thickness of the Mucus-aqueous Tear Film Layer
Time frame: over 4 hours following instillation of NOV03
Thickness of the mucus-aqueous layer of the tear film, measured in nanometers
Thinning Rate of the Mucus-aqueous Tear Film Layer
Time frame: over 4 hours following instillation of NOV03
The rate of change in the thickness of the tear film mucus-aqueous layer, measured in nanometers/second

Results and safety

Results posted to the registry on 4 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Perfluorohexyloctane	33	27

Primary outcome: Thickness of the Mucus-aqueous Tear Film Layer

Time frame: over 4 hours following instillation of NOV03. Mean (Standard Deviation). Unit: nm

Measure	Perfluorohexyloctane n = 27
Value	3920.3 (797.7)

Population analysed: The study had substantial technical data collection issues that prevented many of the subjects' parameter scores from being saved and analyzed. For the mucus-aqueous layer thickness the number of study eyes for which measurements were collected ranged from 15-24 rather than the planned 30 study eyes. Analysis was conducted without imputation of data. Thus, results were inconclusive due to data collection issues.

Primary outcome: Thinning Rate of the Mucus-aqueous Tear Film Layer

Time frame: over 4 hours following instillation of NOV03. Mean (Standard Deviation). Unit: nm/s

Measure	Perfluorohexyloctane n = 27
Value	-62.3 (90.9)

Population analysed: The study had substantial technical data collection issues that prevented many of the subjects' parameter scores from being saved and analyzed. 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.

Adverse events

Time frame: Assessed for the entire study; Visit 1 Screening through Visit 2, an average of 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Perfluorohexyloctane	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing instillation of NOV03 in people with Dry Eye Disease (DED), run by Bausch & Lomb Incorporated at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thickness of the Mucus-aqueous Tear Film Layer (time frame: over 4 hours following instillation of NOV03). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05723770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.