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Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells

This study has been terminated.
(insufficient enrollment)
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: May 23, 2007
Last updated: August 15, 2016
Last verified: August 2016
Results First Received: March 17, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Open Angle Glaucoma
Interventions: Drug: Acular LS
Drug: Pred Forte
Other: Refresh Tears

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Prospective study participants will be identified by a routine clinic visit at Rocky Mountain Lions Eye Institute, University of Colorado, and need to undergo selective laser trabeculoplasty treatment for their glaucoma. A study investigator will make the initial patient contact for recruitment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The patients enrolled in this study will follow standard of care practice in regards to selective laser trabeculoplasty with the exception that the patients will be randomized 1:1:1 (Acular LS: Pred Forte: Refresh Tears) to the inflammation treatment given after the procedure.

Reporting Groups
Acular LS

Acular LS - 1 drop in treated eye, 4 times a day, for 4 days

Acular LS: Details covered in arm description

Pred Forte

Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days

Pred Forte: Details covered in arm description

Refresh Tears

Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days

Refresh Tears: Placebo

Participant Flow:   Overall Study
    Acular LS     Pred Forte     Refresh Tears  
STARTED     10     7     14  
COMPLETED     10     7     14  
NOT COMPLETED     0     0     0  

  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
Placebo Group Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
Acular Group Used acular LS
Predforte Group Used predforte eye drops
Total Total of all reporting groups

Baseline Measures
    Placebo Group     Acular Group     Predforte Group     Total  
Number of Participants  
[units: participants]
  14     10     7     31  
[units: participants]
<=18 years     0     0     0     0  
Between 18 and 65 years     3     4     1     8  
>=65 years     11     6     6     23  
[units: years]
Median (Inter-Quartile Range)
  (62 to 71)  
  (60.5 to 73)  
  (66.5 to 77.5)  
  (63 to 72.5)  
[units: participants]
Female     13     6     3     22  
Male     1     4     4     9  

  Outcome Measures

1.  Primary:   Interocular Pressure   [ Time Frame: 8 weeks ]

  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.

Results Point of Contact:  
Name/Title: Malik Kahook, MD
Organization: University of Colorado, Dept. of Ophthalmology
phone: 720-848-2501

Responsible Party: University of Colorado, Denver Identifier: NCT00478036     History of Changes
Other Study ID Numbers: 06-1251
Study First Received: May 23, 2007
Results First Received: March 17, 2016
Last Updated: August 15, 2016
Health Authority: United States: Institutional Review Board