Trial Outcomes & Findings for Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye (NCT NCT02965846)

Last Updated: 2018-11-30

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

43 participants

Primary outcome timeframe

6 month visit

Results posted on

2018-11-30

Participant Flow

Of the 43 participants who enrolled in the study, 10 were randomized and received intervention to compromise the safety and Intent to Treat (ITT) populations

Participant milestones

Participant milestones
Measure	AGN-195263 One drop of 0.1% AGN-195263 instilled in each eye twice daily	Vehicle One drop of Vehicle (placebo) instilled in each eye twice daily	Enrolled But Not Randomized Run-In period before randomization
Overall Study STARTED	5	5	33
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	5	5	33

Reasons for withdrawal

Reasons for withdrawal
Measure	AGN-195263 One drop of 0.1% AGN-195263 instilled in each eye twice daily	Vehicle One drop of Vehicle (placebo) instilled in each eye twice daily	Enrolled But Not Randomized Run-In period before randomization
Overall Study Lost to Follow-up	1	0	0
Overall Study Withdrawal by Subject	0	1	0
Overall Study Study Terminated By Sponsor	4	4	0
Overall Study Participants not randomized	0	0	33

Baseline Characteristics

Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 month visit

Population: Efficacy analyses including the overall ocular discomfort score were planned. Ultimately, these analyses were not performed due to the fact that the study was terminated before the primary/secondary efficacy visit could be reached.

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

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (day 1) to 6 month visit

Population: Efficacy analyses including the change from baseline in Tearfilm Break Up Time (TBUT) were planned. Ultimately, these analyses were not performed due to the fact that the study was terminated before the primary/secondary efficacy visit could be reached.

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 the analysis.

Outcome measures

Outcome data not reported

Adverse Events

AGN-195263

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	AGN-195263 n=5 participants at risk One drop of 0.1% AGN-195263 instilled in each eye twice daily	Vehicle n=5 participants at risk One drop of Vehicle (placebo) instilled in each eye twice daily
Eye disorders Vision Blurred	0.00% 0/5 • Up to 157 days Adverse Events were collected for randomized patients only.	20.0% 1/5 • Number of events 1 • Up to 157 days Adverse Events were collected for randomized patients only.

Additional Information

Therapeutic Area Head

Allergan, Inc.

Phone: 877-277-8566

Email: [email protected]

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

Measure	AGN-195263 n=5 Participants One drop of 0.1% AGN-195263 instilled in each eye twice daily	Vehicle n=5 Participants One drop of Vehicle (placebo) instilled in each eye twice daily	Enrolled But Not Randomized n=33 Participants Run-In period before randomization	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=33 Participants	0 Participants n=43 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=5 Participants	27 Participants n=33 Participants	36 Participants n=43 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=5 Participants	6 Participants n=33 Participants	7 Participants n=43 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=5 Participants	23 Participants n=33 Participants	26 Participants n=43 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=5 Participants	10 Participants n=33 Participants	17 Participants n=43 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=33 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=5 Participants	6 Participants n=33 Participants	6 Participants n=43 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=33 Participants	1 Participants n=43 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=5 Participants	10 Participants n=33 Participants	17 Participants n=43 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=5 Participants	16 Participants n=33 Participants	19 Participants n=43 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=33 Participants	0 Participants n=43 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=33 Participants	0 Participants n=43 Participants
BMI	34.34 kg/m^2 STANDARD_DEVIATION 10.649807509998 • n=5 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.	34.86 kg/m^2 STANDARD_DEVIATION 9.1331484166195 • n=5 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.	32.788 kg/m^2 STANDARD_DEVIATION 9.4405643899081 • n=25 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.	33.996 kg/m^2 STANDARD_DEVIATION .65464394984732 • n=35 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.
Weight	101.44 kg STANDARD_DEVIATION 23.543542639119 • n=5 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.	102.56 kg STANDARD_DEVIATION 20.180247768548 • n=5 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.	87.868 kg STANDARD_DEVIATION 25.016006395906 • n=25 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.	97.2893 kg STANDARD_DEVIATION 2.0238704230461 • n=35 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.
Height	173.44 cm STANDARD_DEVIATION 5.6683683719391 • n=5 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.	172.9 cm STANDARD_DEVIATION 5.8343808583259 • n=5 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.	163.74 cm STANDARD_DEVIATION 9.2099077085495 • n=25 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.	170.026 cm STANDARD_DEVIATION 1.6317762147419 • n=35 Participants • Data missing for 8 out of the 33 participants in the enrolled but not randomized arm.