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insufficient enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acular LS | Active Comparator | Acular LS - 1 drop in treated eye, 4 times a day, for 4 days |
|
| Pred Forte | Active Comparator | Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days |
|
| Refresh Tears | Placebo Comparator | Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acular LS | Drug | Details covered in arm description |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Interocular Pressure | IOP, measured by Goldmann applanation tonometry | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malik Y. Kahook, MD | Rocky Mountain Lions Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Eye Center | Aurora | Colorado | 80045 | United States |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acular LS | Acular LS - 1 drop in treated eye, 4 times a day, for 4 days Acular LS: Details covered in arm description |
| FG001 | Pred Forte | Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days Pred Forte: Details covered in arm description |
| FG002 | Refresh Tears | Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days Refresh Tears: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group | Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days |
| BG001 | Acular Group | Used acular LS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Interocular Pressure | IOP, measured by Goldmann applanation tonometry | Reported for subjects for whom all IOP values were available for all of the visits. | Posted | Mean | Standard Deviation | mmHg | 8 weeks |
|
5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acular LS | Acular LS - 1 drop in treated eye, 4 times a day, for 4 days Acular LS: Details covered in arm description |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Malik Kahook, MD | University of Colorado, Dept. of Ophthalmology | 720-848-2501 | Malik.kahook@ucdenver.edu |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D009883 | Ophthalmic Solutions |
| C009935 | prednisolone acetate |
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Pred Forte | Drug | Details covered in arm description |
|
|
| Refresh Tears | Other | Placebo |
|
|
| BG002 | Predforte Group | Used predforte eye drops |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days Refresh Tears: Placebo |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Pred Forte | Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days Pred Forte: Details covered in arm description | 0 | 7 | 0 | 7 |
| EG002 | Refresh Tears | Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days Refresh Tears: Placebo | 0 | 14 | 0 | 14 |
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| D006571 | Heterocyclic Compounds |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |