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Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye

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ClinicalTrials.gov Identifier: NCT02815293
Recruitment Status : Terminated
First Posted : June 28, 2016
Results First Posted : February 19, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dry Eye Syndromes
Interventions Drug: AGN-195263
Drug: Vehicle
Enrollment 36
Recruitment Details 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
Pre-assignment Details This study was terminated
Arm/Group Title AGN-195263 Vehicle Enrolled But Not Randomized
Hide Arm/Group Description One drop of 0.1% AGN-195263 instilled in each eye twice daily One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. Run-In period before randomization
Period Title: Overall Study
Started 10 8 18
Completed 0 0 0
Not Completed 10 8 18
Reason Not Completed
Study termination by sponsor             10             7             0
Participants not randomized             0             0             18
Adverse Event             0             1             0
Arm/Group Title AGN-195263 Vehicle Enrolled But Not Randomized Total
Hide Arm/Group Description One drop of 0.1% AGN-195263 instilled in each eye twice daily One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily. Run-In period before randomization Total of all reporting groups
Overall Number of Baseline Participants 10 8 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  60.0%
3
  37.5%
9
  50.0%
18
  50.0%
>=65 years
4
  40.0%
5
  62.5%
9
  50.0%
18
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants 36 participants
Female
7
  70.0%
3
  37.5%
12
  66.7%
22
  61.1%
Male
3
  30.0%
5
  62.5%
6
  33.3%
14
  38.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 18 participants 36 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
  12.5%
2
  11.1%
3
   8.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  20.0%
1
  12.5%
6
  33.3%
9
  25.0%
White
8
  80.0%
6
  75.0%
10
  55.6%
24
  66.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Weight (kg) / height (m)^2
Number Analyzed 10 participants 8 participants 12 participants 30 participants
27.43  (4.4580376849013) 27.3375  (4.8256961932969) 29.6  (7.4233864689013) 28.1225  (1.3197836926109)
[1]
Measure Analysis Population Description: Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 10 participants 8 participants 12 participants 30 participants
73.32  (11.022504252664) 74.3  (16.250384610833) 82.68  (19.69071093745) 76.76  (3.5637743007958)
[1]
Measure Analysis Population Description: Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 10 participants 8 participants 12 participants 30 participants
163.78  (8.5922988774833) 165.0875  (17.14697039567) 167.63  (9.8016438530597) 165.499  (3.7800461794887)
[1]
Measure Analysis Population Description: Data missing for 6 out of the 18 participants in the enrolled but not randomized arm.
1.Primary Outcome
Title Overall Ocular Discomfort Score (0 to 4 Scale; 0=None, 4=Very Severe)
Hide Description 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.
Time Frame 6 month visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AGN-195263 Vehicle
Hide Arm/Group Description:
One drop of 0.1% AGN-195263 instilled in each eye twice daily
One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: Score on a scale
1.66  (0.513) 1.75  (0.204)
2.Secondary Outcome
Title Change From Baseline in Tearfilm Break Up Time (TBUT)
Hide Description 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
Time Frame Baseline (day 1) to 6 month visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AGN-195263 Vehicle
Hide Arm/Group Description:
One drop of 0.1% AGN-195263 instilled in each eye twice daily
One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: Seconds
3.18  (0.284) 3.16  (0.286)
Time Frame Up to 223 days
Adverse Event Reporting Description Adverse Events reported for randomized patients only
 
Arm/Group Title AGN-195263 Vehicle
Hide Arm/Group Description One drop of 0.1% AGN-195263 instilled in each eye twice daily One drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
All-Cause Mortality
AGN-195263 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
AGN-195263 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   1/8 (12.50%) 
Injury, poisoning and procedural complications     
Laceration  1  0/10 (0.00%)  1/8 (12.50%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AGN-195263 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   2/8 (25.00%) 
Eye disorders     
Conjunctival haemorrhage  1  0/10 (0.00%)  1/8 (12.50%) 
Eye irritation  1  0/10 (0.00%)  1/8 (12.50%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Due to study termination, the study was underpowered
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
As this study was terminated, no data will be published.
Results Point of Contact
Name/Title: Therapeutic Area Head
Organization: Allergan, Inc.
Phone: 877-277-8566
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02815293     History of Changes
Other Study ID Numbers: 195263-009
First Submitted: June 24, 2016
First Posted: June 28, 2016
Results First Submitted: June 18, 2018
Results First Posted: February 19, 2019
Last Update Posted: February 19, 2019