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A Study of AGN-195263 for the Treatment of Meibomian Gland Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01633788
First received: July 2, 2012
Last updated: August 10, 2017
Last verified: August 2017
Results First Received: August 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Meibomian Gland Dysfunction
Interventions: Drug: AGN-195263 0.1%
Drug: AGN-195263 0.03%
Drug: AGN-195263 0.01%
Drug: AGN-195263 Vehicle

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients from one site were excluded from the modified intent-to-treat analysis population due to compliance issues. Patients from this site who received study treatment were included in the safety population and are reflected in the participant flow.

Reporting Groups
  Description
AGN-195263 0.1% 1 drop of AGN-195263 0.1% instilled in each eye twice daily.
AGN-195263 0.03% 1 drop of AGN-195263 0.03% instilled in each eye twice daily.
AGN-195263 0.01% 1 drop of AGN-195263 0.01% instilled in each eye twice daily.
AGN-195263 Vehicle 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.

Participant Flow:   Overall Study
    AGN-195263 0.1%   AGN-195263 0.03%   AGN-195263 0.01%   AGN-195263 Vehicle
STARTED   57   58   59   58 
COMPLETED   50   50   49   45 
NOT COMPLETED   7   8   10   13 
Adverse Event                1                3                3                3 
Lost to Follow-up                2                2                2                0 
Personal Reasons                3                1                1                3 
Protocol Violation                1                0                1                0 
Other Reasons                0                2                3                7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AGN-195263 0.1% 1 drop of AGN-195263 0.1% instilled in each eye twice daily.
AGN-195263 0.03% 1 drop of AGN-195263 0.03% instilled in each eye twice daily.
AGN-195263 0.01% 1 drop of AGN-195263 0.01% instilled in each eye twice daily.
AGN-195263 Vehicle 1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
Total Total of all reporting groups

Baseline Measures
   AGN-195263 0.1%   AGN-195263 0.03%   AGN-195263 0.01%   AGN-195263 Vehicle   Total 
Overall Participants Analyzed 
[Units: Participants]
 57   58   59   58   232 
Age, Customized 
[Units: Participants]
         
40 year to less than 55 years   17   17   20   19   73 
55 years to 65 years   26   24   19   18   87 
over 65 years   14   17   20   21   72 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      39  68.4%      39  67.2%      39  66.1%      39  67.2%      156  67.2% 
Male      18  31.6%      19  32.8%      20  33.9%      19  32.8%      76  32.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Meibum Quality Responders in the Study Eye   [ Time Frame: Month 6 ]

2.  Secondary:   Percentage of Maximum Meibum Quality Score (MMQS) Responders in the Study Eye   [ Time Frame: Month 6 ]

3.  Secondary:   Percentage of Complete Overall Ocular Discomfort Responders   [ Time Frame: Month 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ronald Bradford
Organization: Allergan plc
phone: 1-714-846-5486
e-mail: Bradford_Ron@allergan.com



Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01633788     History of Changes
Other Study ID Numbers: 195263-006
Study First Received: July 2, 2012
Results First Received: August 10, 2017
Last Updated: August 10, 2017