Trial Outcomes & Findings for Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye (NCT NCT02815293)
NCT ID: NCT02815293
Last Updated: 2019-02-19
Results Overview
The overall ocular discomfort will be assessed on a questionnaire using a 0 to 4 scale on which 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
6 month visit
Results posted on
2019-02-19
Participant Flow
Of the 36 participants who enrolled in the study, 18 were randomized and received intervention to comprise the safety and Intent to Treat (ITT) populations
This study was terminated
Participant milestones
| Measure |
AGN-195263
One drop of 0.1% AGN-195263 instilled in each eye twice daily
|
Vehicle
One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
Enrolled But Not Randomized
Run-In period before randomization
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
18
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
18
|
Reasons for withdrawal
| Measure |
AGN-195263
One drop of 0.1% AGN-195263 instilled in each eye twice daily
|
Vehicle
One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
Enrolled But Not Randomized
Run-In period before randomization
|
|---|---|---|---|
|
Overall Study
Study termination by sponsor
|
10
|
7
|
0
|
|
Overall Study
Participants not randomized
|
0
|
0
|
18
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
Baseline characteristics by cohort
| Measure |
AGN-195263
n=10 Participants
One drop of 0.1% AGN-195263 instilled in each eye twice daily
|
Vehicle
n=8 Participants
One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
Enrolled But Not Randomized
n=18 Participants
Run-In period before randomization
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=18 Participants
|
18 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=10 Participants
|
5 Participants
n=8 Participants
|
9 Participants
n=18 Participants
|
18 Participants
n=36 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
12 Participants
n=18 Participants
|
22 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=10 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=18 Participants
|
14 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
6 Participants
n=18 Participants
|
9 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
10 Participants
n=18 Participants
|
24 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=36 Participants
|
|
BMI
|
27.43 weight (kg) / height (m)^2
STANDARD_DEVIATION 4.4580376849013 • n=10 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
27.3375 weight (kg) / height (m)^2
STANDARD_DEVIATION 4.8256961932969 • n=8 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
29.6 weight (kg) / height (m)^2
STANDARD_DEVIATION 7.4233864689013 • n=12 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
28.1225 weight (kg) / height (m)^2
STANDARD_DEVIATION 1.3197836926109 • n=30 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
|
Weight
|
73.32 Kg
STANDARD_DEVIATION 11.022504252664 • n=10 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
74.3 Kg
STANDARD_DEVIATION 16.250384610833 • n=8 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
82.68 Kg
STANDARD_DEVIATION 19.69071093745 • n=12 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
76.76 Kg
STANDARD_DEVIATION 3.5637743007958 • n=30 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
|
Height
|
163.78 cm
STANDARD_DEVIATION 8.5922988774833 • n=10 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
165.0875 cm
STANDARD_DEVIATION 17.14697039567 • n=8 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
167.63 cm
STANDARD_DEVIATION 9.8016438530597 • n=12 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
165.499 cm
STANDARD_DEVIATION 3.7800461794887 • n=30 Participants • Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
|
PRIMARY outcome
Timeframe: 6 month visitPopulation: Efficacy analyses including the overall ocular discomfort score were planned for the intent-to-treat (ITT) population who are defined as all randomized patients. Ultimately, these analyses were not fully performed due to the early termination of the study and only six patients reaching the 6 month visit.
The overall ocular discomfort will be assessed on a questionnaire using a 0 to 4 scale on which 0=none, 1=mild, 2=moderate, 3=severe and 4=very severe.
Outcome measures
| Measure |
AGN-195263
n=3 Participants
One drop of 0.1% AGN-195263 instilled in each eye twice daily
|
Vehicle
n=3 Participants
One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
|---|---|---|
|
Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)
|
1.66 Score on a scale
Standard Deviation 0.513
|
1.75 Score on a scale
Standard Deviation 0.204
|
SECONDARY outcome
Timeframe: Baseline (day 1) to 6 month visitPopulation: Efficacy analyses including the change from baseline in Tearfilm Break Up Time (TBUT) were planned. Ultimately, these analyses were not fully performed due to the early termination of the study and only six patients reaching the 6 month visit.
For TBUT, the mean of 3 measurements of time in seconds will be computed at each visit for each eye. The mean value of the study eye will be used for analysis
Outcome measures
| Measure |
AGN-195263
n=3 Participants
One drop of 0.1% AGN-195263 instilled in each eye twice daily
|
Vehicle
n=3 Participants
One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
|---|---|---|
|
Change From Baseline in Tearfilm Break Up Time (TBUT)
|
3.18 Seconds
Standard Deviation 0.284
|
3.16 Seconds
Standard Deviation 0.286
|
Adverse Events
AGN-195263
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AGN-195263
n=10 participants at risk
One drop of 0.1% AGN-195263 instilled in each eye twice daily
|
Vehicle
n=8 participants at risk
One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/10 • Up to 223 days
Adverse Events reported for randomized patients only
|
12.5%
1/8 • Up to 223 days
Adverse Events reported for randomized patients only
|
Other adverse events
| Measure |
AGN-195263
n=10 participants at risk
One drop of 0.1% AGN-195263 instilled in each eye twice daily
|
Vehicle
n=8 participants at risk
One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
|
|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/10 • Up to 223 days
Adverse Events reported for randomized patients only
|
12.5%
1/8 • Up to 223 days
Adverse Events reported for randomized patients only
|
|
Eye disorders
Eye irritation
|
0.00%
0/10 • Up to 223 days
Adverse Events reported for randomized patients only
|
12.5%
1/8 • Up to 223 days
Adverse Events reported for randomized patients only
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee As this study was terminated, no data will be published.
- Publication restrictions are in place
Restriction type: OTHER