An interventional study of Acular LS and Pred Forte in Open Angle Glaucoma, sponsored by University of Colorado, Denver. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-07.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 31 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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Exclusion Criteria:
Acular LS - 1 drop in treated eye, 4 times a day, for 4 days
Drug: Acular LS
Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days
Drug: Pred Forte
Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
Other: Refresh Tears
Details covered in arm description
Also known as: KETOROLAC TROMETHAMINE 0.5% SOLUTION - OPHTHALMIC
Details covered in arm description
Also known as: Prednisolone acetate ophthalmic suspension 1%
Placebo
Also known as: CARBOXYMETHYLCELLULOSE SODIUM
Interocular Pressure
IOP, measured by Goldmann applanation tonometry
Time frame: 8 weeks
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.
| Milestone | Acular LS | Pred Forte | Refresh Tears |
|---|---|---|---|
| Started | 10 | 7 | 14 |
| Completed | 10 | 7 | 14 |
| Not completed | 0 | 0 | 0 |
IOP, measured by Goldmann applanation tonometry
| mmHg | Acular LS | Pred Forte | Refresh Tears |
|---|---|---|---|
| Baseline | 16.1 ± 3.1 | 17.0 ± 3.3 | 17.8 ± 4.5 |
| Day 1 | 11.6 ± 2.2 | 12.4 ± 2.5 | 13.4 ± 3.3 |
| Week 1 | 15.2 ± 3.3 | 15.7 ± 2.8 | 15.6 ± 3.7 |
| Week 4 | 14.3 ± 2.6 | 14.0 ± 2.4 | 14.6 ± 3.5 |
| week 8 | 14.0 ± 2.3 | 15.0 ± 1.6 | 15.8 ± 3.1 |
Collected over 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Acular LS | — | 0/10 (0%) | 0/10 (0%) |
| Pred Forte | — | 0/7 (0%) | 0/7 (0%) |
| Refresh Tears | — | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | Placebo Group | Acular Group | Predforte Group | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 4 | 1 | 8 |
| >=65 years | 11 | 6 | 6 | 23 |
| Age, Continuous(years) | Placebo Group | Acular Group | Predforte Group | Total |
|---|---|---|---|---|
| Median | 68 (62 to 71) | 69.5 (60.5 to 73) | 73 (66.5 to 77.5) | 69 (63 to 72.5) |
| Sex: Female, Male(Participants) | Placebo Group | Acular Group | Predforte Group | Total |
|---|---|---|---|---|
| Female | 13 | 6 | 3 | 22 |
| Male | 1 | 4 | 4 | 9 |
Plan to share: No
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This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver