Trial Outcomes & Findings for Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study) (NCT NCT04139798)
NCT ID: NCT04139798
Last Updated: 2024-10-23
Results Overview
Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
599 participants
Primary outcome timeframe
Assessed from Baseline to Day 57
Results posted on
2024-10-23
Participant Flow
Participant milestones
| Measure |
NOV03 4 Times Daily (QID)
100% Perfluorohexyloctance solution 4 times daily (QID)
NOV03: 100% Perfluorohexyloctane
|
Placebo 4 Times Daily (QID)
Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
Placebo: Saline solution (0.6% sodium chloride solution)
|
|---|---|---|
|
Overall Study
STARTED
|
303
|
294
|
|
Overall Study
COMPLETED
|
289
|
279
|
|
Overall Study
NOT COMPLETED
|
14
|
15
|
Reasons for withdrawal
| Measure |
NOV03 4 Times Daily (QID)
100% Perfluorohexyloctance solution 4 times daily (QID)
NOV03: 100% Perfluorohexyloctane
|
Placebo 4 Times Daily (QID)
Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
Placebo: Saline solution (0.6% sodium chloride solution)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Discontinued
|
4
|
2
|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
Baseline characteristics by cohort
| Measure |
NOV03 4 Times Daily (QID)
n=303 Participants
100% Perfluorohexyloctance solution 4 times daily (QID)
NOV03: 100% Perfluorohexyloctane
|
Placebo 4 Times Daily (QID)
n=294 Participants
Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
Placebo: Saline solution (0.6% sodium chloride solution)
|
Total
n=597 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 14.23 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 13.57 • n=7 Participants
|
60.9 years
STANDARD_DEVIATION 13.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
219 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
433 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
43 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
260 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
503 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 from Baseline to Day 57Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.
Outcome measures
| Measure |
NOV03 4 Times Daily (QID)
n=289 Eyes
100% Perfluorohexyloctance solution 4 times daily (QID)
NOV03: 100% Perfluorohexyloctane
|
Placebo 4 Times Daily (QID)
n=279 Participants
Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
Placebo: Saline solution (0.6% sodium chloride solution)
|
|---|---|---|
|
Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57
|
-2.0 units on a scale
Standard Deviation 2.6
|
-1.0 units on a scale
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Assessed from Baseline to Day 57Dryness Score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort).
Outcome measures
| Measure |
NOV03 4 Times Daily (QID)
n=289 Eyes
100% Perfluorohexyloctance solution 4 times daily (QID)
NOV03: 100% Perfluorohexyloctane
|
Placebo 4 Times Daily (QID)
n=279 Eyes
Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
Placebo: Saline solution (0.6% sodium chloride solution)
|
|---|---|---|
|
Change From Baseline of Dryness Score at Day 57
|
-27.4 units on a scale
Standard Deviation 27.9
|
-19.7 units on a scale
Standard Deviation 26.7
|
Adverse Events
NOV03 4 Times Daily (QID)
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo 4 Times Daily (QID)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NOV03 4 Times Daily (QID)
n=303 participants at risk
100% Perfluorohexyloctance solution 4 times daily (QID)
NOV03: 100% Perfluorohexyloctane
|
Placebo 4 Times Daily (QID)
n=294 participants at risk
Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
Placebo: Saline solution (0.6% sodium chloride solution)
|
|---|---|---|
|
Eye disorders
Vision blurred
|
3.0%
9/303 • Assessed throughout the study, approximately 8 weeks.
Ocular Treatment-emergent Adverse Events
|
0.34%
1/294 • Assessed throughout the study, approximately 8 weeks.
Ocular Treatment-emergent Adverse Events
|
|
Eye disorders
Instillation site pain
|
0.99%
3/303 • Assessed throughout the study, approximately 8 weeks.
Ocular Treatment-emergent Adverse Events
|
1.0%
3/294 • Assessed throughout the study, approximately 8 weeks.
Ocular Treatment-emergent Adverse Events
|
|
Eye disorders
Conjunctival haemorrhage
|
0.33%
1/303 • Assessed throughout the study, approximately 8 weeks.
Ocular Treatment-emergent Adverse Events
|
1.4%
4/294 • Assessed throughout the study, approximately 8 weeks.
Ocular Treatment-emergent Adverse Events
|
|
Eye disorders
Eye discharge
|
0.99%
3/303 • Assessed throughout the study, approximately 8 weeks.
Ocular Treatment-emergent Adverse Events
|
0.00%
0/294 • Assessed throughout the study, approximately 8 weeks.
Ocular Treatment-emergent Adverse Events
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/303 • Assessed throughout the study, approximately 8 weeks.
Ocular Treatment-emergent Adverse Events
|
1.0%
3/294 • Assessed throughout the study, approximately 8 weeks.
Ocular Treatment-emergent Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place