Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
Primary Purpose
Open Angle Glaucoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acular LS
Pred Forte
Refresh Tears
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma focused on measuring glaucoma, selective laser trabeculoplasty, anterior chamber flare
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with open angle glaucoma patients at the Rocky Mountain Lions Eye Institute Glaucoma Clinic.
- Able to provide written informed consent to participate.
- Must be the age of 18 years of age or older.
- Patients in which further intraocular pressure lowering by selective laser trabeculoplasty is necessary in the opinion of the treating physician.
Exclusion Criteria:
- Patients with eye surgery in the prior six months.
- Patients with prior or current use of topical or systemic corticosteroids or NSAIDs.
- Patients with pre-existing anterior chamber inflammation.
- Patients with known sensitivity to any of the study medications.
- Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study
Sites / Locations
- University of Colorado Eye Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Acular LS
Pred Forte
Refresh Tears
Arm Description
Acular LS - 1 drop in treated eye, 4 times a day, for 4 days
Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days
Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
Outcomes
Primary Outcome Measures
Interocular Pressure
IOP, measured by Goldmann applanation tonometry
Secondary Outcome Measures
Full Information
NCT ID
NCT00478036
First Posted
May 23, 2007
Last Updated
August 15, 2016
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT00478036
Brief Title
Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
Official Title
A Randomized Prospective Double Masked Controlled Trial Comparing Ketorolac Tromethamine 0.4% and Prednisolone Acetate 1% in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
insufficient enrollment
Study Start Date
May 2007 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Investigators will compare, in a randomized, prospective, masked and controlled fashion the effect of a non-steroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure (IOP) lowering and degree of ocular inflammation following selective laser trabeculoplasty treatment for open angle glaucoma.
Detailed Description
Currently, many ophthalmologists use anti-inflammatory agents like corticosteroids and nonsteroidal anti-inflammatory agents (NSAIDs) as a preventative measure to control the post-selective laser trabeculoplasty (SLT) anterior chamber inflammation. Both classes of compounds reduce inflammation through the inhibition of the cyclooxygenase pathway, whereas the corticosteroid class also inhibits the lipoxygenase pathway of the arachidonic acid cascade. Although effective, topical corticosteroids are associated with increase in intraocular pressure (IOP), posterior subcapsular cataract formation, and reduced response to infection. These adverse side effects have not been reported to occur with topical NSAIDs, which are effective in controlling the pain after SLT along with the prevention and suppression of the ocular inflammation. There are ophthalmologists who forgo using the anti-inflammatory agents post SLT and prescribe Refresh Tears to their patients to comfort the treated eye.
The significance of the study lies in assessing the efficacy of Acular LS, compared to Pred Forte and to Refresh Tears in reducing discomfort, inflammation and maximizing IOP lowering following SLT procedure for open angle glaucoma with the hope of resolving the dispute over the effective post-operative care in SLT patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
Keywords
glaucoma, selective laser trabeculoplasty, anterior chamber flare
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acular LS
Arm Type
Active Comparator
Arm Description
Acular LS - 1 drop in treated eye, 4 times a day, for 4 days
Arm Title
Pred Forte
Arm Type
Active Comparator
Arm Description
Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days
Arm Title
Refresh Tears
Arm Type
Placebo Comparator
Arm Description
Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
Intervention Type
Drug
Intervention Name(s)
Acular LS
Other Intervention Name(s)
KETOROLAC TROMETHAMINE 0.5% SOLUTION - OPHTHALMIC
Intervention Description
Details covered in arm description
Intervention Type
Drug
Intervention Name(s)
Pred Forte
Other Intervention Name(s)
Prednisolone acetate ophthalmic suspension 1%
Intervention Description
Details covered in arm description
Intervention Type
Other
Intervention Name(s)
Refresh Tears
Other Intervention Name(s)
CARBOXYMETHYLCELLULOSE SODIUM
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Interocular Pressure
Description
IOP, measured by Goldmann applanation tonometry
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed with open angle glaucoma patients at the Rocky Mountain Lions Eye Institute Glaucoma Clinic.
Able to provide written informed consent to participate.
Must be the age of 18 years of age or older.
Patients in which further intraocular pressure lowering by selective laser trabeculoplasty is necessary in the opinion of the treating physician.
Exclusion Criteria:
Patients with eye surgery in the prior six months.
Patients with prior or current use of topical or systemic corticosteroids or NSAIDs.
Patients with pre-existing anterior chamber inflammation.
Patients with known sensitivity to any of the study medications.
Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malik Y. Kahook, MD
Organizational Affiliation
Rocky Mountain Lions Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Eye Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
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