Trial Outcomes & Findings for Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) (NCT NCT03333057)
NCT ID: NCT03333057
Last Updated: 2022-01-04
Results Overview
The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8 The NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
336 participants
Primary outcome timeframe
baseline and 2 months
Results posted on
2022-01-04
Participant Flow
Participant milestones
| Measure |
NOV03 2 Times Daily (BID)
Perfluorohexyloctance solution 2 times daily (BID)
NOV03: Perfluorohexyloctane
|
NOV03 4 Times Daily (QID)
Perfluorohexyloctance solution 4 times daily
NOV03: Perfluorohexyloctane
|
Placebo BID/QID
Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)
Placebo: Saline solution (0.9% sodium chloride solution)
|
|---|---|---|---|
|
Overall Study
STARTED
|
111
|
114
|
111
|
|
Overall Study
COMPLETED
|
105
|
110
|
108
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Baseline characteristics by cohort
| Measure |
NOV03 2 Times Daily (BID)
n=111 Participants
Perfluorohexyloctance solution 2 times daily (BID)
NOV03: Perfluorohexyloctane
|
NOV03 4 Times Daily (QID)
n=114 Participants
Perfluorohexyloctance solution 4 times daily
NOV03: Perfluorohexyloctane
|
Placebo BID/QID
n=111 Participants
Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)
Placebo: Saline solution (0.9% sodium chloride solution)
|
Total
n=336 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.0 years
n=5 Participants
|
53.0 years
n=7 Participants
|
53.8 years
n=5 Participants
|
53.6 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
243 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
259 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
114 participants
n=7 Participants
|
111 participants
n=5 Participants
|
336 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline and 2 monthsThe primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8 The NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
Outcome measures
| Measure |
NOV03 2 Times Daily (BID)
n=111 Participants
Perfluorohexyloctance solution 2 times daily (BID)
NOV03: Perfluorohexyloctane
|
NOV03 4 Times Daily (QID)
n=114 Participants
Perfluorohexyloctance solution 4 times daily
NOV03:Perfluorohexyloctane
|
Placebo BID/QID
n=111 Participants
Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)
Placebo: Saline solution (0.9% sodium chloride solution)
|
|---|---|---|---|
|
Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading)
|
-1.78 score on a scale
Interval -2.27 to -1.3
|
-2.11 score on a scale
Interval -2.59 to -1.63
|
-0.93 score on a scale
Interval -1.41 to -0.45
|
Adverse Events
NOV03 2 Times Daily (BID)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
NOV03 4 Times Daily (QID)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo BID/QID
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NOV03 2 Times Daily (BID)
n=111 participants at risk
Perfluorohexyloctance solution 2 times daily (BID)
NOV03: Perfluorohexyloctane
|
NOV03 4 Times Daily (QID)
n=114 participants at risk
Perfluorohexyloctance solution 4 times daily
NOV03: Perfluorohexyloctane
|
Placebo BID/QID
n=111 participants at risk
Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)
Placebo: Saline solution (0.9% sodium chloride solution)
|
|---|---|---|---|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/111 • whole study duration (8 weeks per patient)
|
0.88%
1/114 • Number of events 1 • whole study duration (8 weeks per patient)
|
0.00%
0/111 • whole study duration (8 weeks per patient)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/111 • whole study duration (8 weeks per patient)
|
0.88%
1/114 • Number of events 1 • whole study duration (8 weeks per patient)
|
0.00%
0/111 • whole study duration (8 weeks per patient)
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/111 • whole study duration (8 weeks per patient)
|
0.88%
1/114 • Number of events 1 • whole study duration (8 weeks per patient)
|
0.00%
0/111 • whole study duration (8 weeks per patient)
|
|
General disorders
Chest pain
|
0.90%
1/111 • Number of events 1 • whole study duration (8 weeks per patient)
|
0.00%
0/114 • whole study duration (8 weeks per patient)
|
0.00%
0/111 • whole study duration (8 weeks per patient)
|
Other adverse events
| Measure |
NOV03 2 Times Daily (BID)
n=111 participants at risk
Perfluorohexyloctance solution 2 times daily (BID)
NOV03: Perfluorohexyloctane
|
NOV03 4 Times Daily (QID)
n=114 participants at risk
Perfluorohexyloctance solution 4 times daily
NOV03: Perfluorohexyloctane
|
Placebo BID/QID
n=111 participants at risk
Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)
Placebo: Saline solution (0.9% sodium chloride solution)
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/111 • whole study duration (8 weeks per patient)
|
1.8%
2/114 • Number of events 2 • whole study duration (8 weeks per patient)
|
0.90%
1/111 • Number of events 1 • whole study duration (8 weeks per patient)
|
|
General disorders
Instillation site pain
|
0.90%
1/111 • Number of events 2 • whole study duration (8 weeks per patient)
|
1.8%
2/114 • Number of events 2 • whole study duration (8 weeks per patient)
|
0.00%
0/111 • whole study duration (8 weeks per patient)
|
|
General disorders
Instillation site irritation
|
0.00%
0/111 • whole study duration (8 weeks per patient)
|
0.00%
0/114 • whole study duration (8 weeks per patient)
|
1.8%
2/111 • Number of events 2 • whole study duration (8 weeks per patient)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60