Trial Outcomes & Findings for Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study) (NCT NCT04567329)

Results Overview

The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

620 participants

Primary outcome timeframe

Assessed at Day 57

Results posted on

2024-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	NOV03 100% perfluorohexyloctane 4 times daily (QID) NOV03: 100% perfluorohexyloctane	Saline Solution 0.6% sodium chloride solution 4 times daily (QID) Saline Solution: 0.6% sodium chloride solution
Overall Study STARTED	311	309
Overall Study COMPLETED	302	296
Overall Study NOT COMPLETED	9	13

Reasons for withdrawal

Reasons for withdrawal
Measure	NOV03 100% perfluorohexyloctane 4 times daily (QID) NOV03: 100% perfluorohexyloctane	Saline Solution 0.6% sodium chloride solution 4 times daily (QID) Saline Solution: 0.6% sodium chloride solution
Overall Study Withdrawal by Subject	5	6
Overall Study Protocol Violation	2	3
Overall Study Discontinued	2	2
Overall Study Lost to Follow-up	0	1
Overall Study Lack of Efficacy	0	1

Baseline Characteristics

Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NOV03 n=311 Participants 100% perfluorohexyloctane 4 times daily (QID) NOV03: 100% perfluorohexyloctane	Saline Solution n=309 Participants 0.6% sodium chloride solution 4 times daily (QID) Saline Solution: 0.6% sodium chloride solution	Total n=620 Participants Total of all reporting groups
Age, Continuous	53.3 years STANDARD_DEVIATION 17.38 • n=5 Participants	53.8 years STANDARD_DEVIATION 16.26 • n=7 Participants	53.6 years STANDARD_DEVIATION 16.82 • n=5 Participants
Sex: Female, Male Female	250 Participants n=5 Participants	238 Participants n=7 Participants	488 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	71 Participants n=7 Participants	132 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	63 Participants n=5 Participants	65 Participants n=7 Participants	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	248 Participants n=5 Participants	244 Participants n=7 Participants	492 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at Day 57

The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).

Outcome measures

Outcome measures
Measure	NOV03 n=311 Participants 100% perfluorohexyloctane 4 times daily (QID) NOV03: 100% perfluorohexyloctane	Saline Solution n=309 Participants 0.6% sodium chloride solution 4 times daily (QID) Saline Solution: 0.6% sodium chloride solution
Change From Baseline in Total Corneal Fluorescein Staining Score (NEI Scale) in the Study Eye at Day 57	-2.3 units on a scale Standard Deviation 2.8	-1.1 units on a scale Standard Deviation 2.9

PRIMARY outcome

Timeframe: Assessed at Day 57

Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").

Outcome measures

Outcome measures
Measure	NOV03 n=311 Participants 100% perfluorohexyloctane 4 times daily (QID) NOV03: 100% perfluorohexyloctane	Saline Solution n=309 Participants 0.6% sodium chloride solution 4 times daily (QID) Saline Solution: 0.6% sodium chloride solution
Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 57	-29.5 units on a scale Standard Deviation 28.6	-19.0 units on a scale Standard Deviation 27.2

SECONDARY outcome

Timeframe: Assessed at Day 15

Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").

Outcome measures

Outcome measures
Measure	NOV03 n=311 Participants 100% perfluorohexyloctane 4 times daily (QID) NOV03: 100% perfluorohexyloctane	Saline Solution n=309 Participants 0.6% sodium chloride solution 4 times daily (QID) Saline Solution: 0.6% sodium chloride solution
Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 15	-18.5 units on a scale Standard Deviation 23.6	-10.5 units on a scale Standard Deviation 23.9

SECONDARY outcome

Timeframe: Assessed at Day 15

The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total of 15 points (sum of scores for each section).

Outcome measures

Outcome measures
Measure	NOV03 n=311 Participants 100% perfluorohexyloctane 4 times daily (QID) NOV03: 100% perfluorohexyloctane	Saline Solution n=309 Participants 0.6% sodium chloride solution 4 times daily (QID) Saline Solution: 0.6% sodium chloride solution
Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) at Day 15	-1.9 units on a scale Standard Error 2.3	-1.3 units on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: Assessed at Day 57

Subjects will be asked about the severity of burning / stinging. Study staff will ask subjects to rate their ocular symptoms (both eyes simultaneously) due to ocular dryness by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no discomfort" and 100% corresponds to "maximal discomfort").

Outcome measures

Outcome measures
Measure	NOV03 n=311 Participants 100% perfluorohexyloctane 4 times daily (QID) NOV03: 100% perfluorohexyloctane	Saline Solution n=309 Participants 0.6% sodium chloride solution 4 times daily (QID) Saline Solution: 0.6% sodium chloride solution
Change From Baseline in Burning/Stinging (Visual Analogue Scale [VAS] Severity of Burning/Stinging) at Day 57	-22.1 units on a scale Standard Deviation 27.5	-13.7 units on a scale Standard Deviation 29.9

SECONDARY outcome

Timeframe: Assessed at Day 57

The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum of 3 points in the central section.

Outcome measures

Outcome measures
Measure	NOV03 n=311 Participants 100% perfluorohexyloctane 4 times daily (QID) NOV03: 100% perfluorohexyloctane	Saline Solution n=309 Participants 0.6% sodium chloride solution 4 times daily (QID) Saline Solution: 0.6% sodium chloride solution
Change From Baseline in Central Corneal Fluorescein Staining (NEI Scale) at Day 57	-0.4 units on a scale Standard Deviation 0.8	-0.1 units on a scale Standard Deviation 0.9

Adverse Events

NOV03

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Saline Solution

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	NOV03 n=311 participants at risk 100% perfluorohexyloctane 4 times daily (QID) NOV03: 100% perfluorohexyloctane	Saline Solution n=309 participants at risk 0.6% sodium chloride solution 4 times daily (QID) Saline Solution: 0.6% sodium chloride solution
Eye disorders Eye disorder	5.1% 16/311 • Assessed through the study, approximately 8 weeks Ocular TEAEs	5.2% 16/309 • Assessed through the study, approximately 8 weeks Ocular TEAEs
Vascular disorders Hyperaemia	0.00% 0/311 • Assessed through the study, approximately 8 weeks Ocular TEAEs	0.97% 3/309 • Assessed through the study, approximately 8 weeks Ocular TEAEs

Additional Information

Daniel Donatello

Bausch & Lomb

Phone: 5853385306

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place