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

University of Colorado Denver (CU Denver)

Status: Terminated

Conditions: Open Angle Glaucoma

Treatments: Drug: Pred Forte; Other: Refresh Tears; Drug: Acular LS

Study type: Interventional

Funder types: Other

Identifiers

NCT00478036

06-1251

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 3 patient groups, including a placebo group

Acular LS

Active Comparator group

Description:

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

Treatment:

Drug: Acular LS

Pred Forte

Active Comparator group

Description:

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

Treatment:

Drug: Pred Forte

Refresh Tears

Placebo Comparator group

Description:

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

Treatment:

Other: Refresh Tears