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

NCT ID: NCT00478036

Last Updated: 2016-10-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2014-01-31

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.

Conditions

Open Angle Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acular LS

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

Group Type: ACTIVE_COMPARATOR

Acular LS

Intervention Type: DRUG

Details covered in arm description

Pred Forte

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

Group Type: ACTIVE_COMPARATOR

Pred Forte

Intervention Type: DRUG

Details covered in arm description

Refresh Tears

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

Group Type: PLACEBO_COMPARATOR

Refresh Tears

Intervention Type: OTHER

Placebo

Interventions

Acular LS

Details covered in arm description

Intervention Type: DRUG

Pred Forte

Details covered in arm description

Intervention Type: DRUG

Refresh Tears

Placebo

Intervention Type: OTHER

Other Intervention Names

KETOROLAC TROMETHAMINE 0.5% SOLUTION - OPHTHALMIC; Prednisolone acetate ophthalmic suspension 1%; CARBOXYMETHYLCELLULOSE SODIUM

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Malik Y. Kahook, MD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Lions Eye Institute

Locations

University of Colorado Eye Center

Aurora, Colorado, United States

Countries

United States

Other Identifiers

06-1251

Identifier Type: -

Identifier Source: org_study_id