Trial Outcomes & Findings for Effects of NOV03 on the Tear Film (NCT NCT05723770)

NCT ID: NCT05723770

Last Updated: 2025-07-04

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: over 4 hours following instillation of NOV03
• Results posted on: 2025-07-04

Participant Flow

Participant milestones

Measure	Perfluorohexyloctane 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.
Overall Study STARTED	33
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Perfluorohexyloctane 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.
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Effects of NOV03 on the Tear Film

Baseline characteristics by cohort

Measure	Perfluorohexyloctane n=27 Participants 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.
Age, Continuous	63.2 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: over 4 hours following instillation of NOV03

Population: 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.

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

Outcome measures

Measure	Perfluorohexyloctane n=27 Participants 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.
Thickness of the Mucus-aqueous Tear Film Layer	3920.3 nm Standard Deviation 797.7

PRIMARY outcome

Timeframe: over 4 hours following instillation of NOV03

Population: 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.

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

Outcome measures

Measure	Perfluorohexyloctane n=27 Participants 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.
Thinning Rate of the Mucus-aqueous Tear Film Layer	-62.3 nm/s Standard Deviation 90.9

Adverse Events

Perfluorohexyloctane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Megan Cavet

Bausch & Lomb

Phone: 5852849474

Email: Megan.Cavet@bausch.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place