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

• ClinicalTrials.gov Identifier: NCT00478036
• Recruitment Status: Terminated
• First Posted: May 24, 2007
• Results First Posted: October 7, 2016
• Last Update Posted: October 7, 2016
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

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.

Condition or disease	Intervention/treatment	Phase
Open Angle Glaucoma	Drug: Acular LS; Drug: Pred Forte; Other: Refresh Tears	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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 Start Date: May 2007
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Acular LS; Acular LS - 1 drop in treated eye, 4 times a day, for 4 days	Drug: Acular LS; Details covered in arm description; Other Name: KETOROLAC TROMETHAMINE 0.5% SOLUTION - OPHTHALMIC
Active Comparator: Pred Forte; Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days	Drug: Pred Forte; Details covered in arm description; Other Name: Prednisolone acetate ophthalmic suspension 1%
Placebo Comparator: Refresh Tears; Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days	Other: Refresh Tears; Placebo; Other Name: CARBOXYMETHYLCELLULOSE SODIUM

Outcome Measures

Primary Outcome Measures :

1. Interocular Pressure [ Time Frame: 8 weeks ]
   IOP, measured by Goldmann applanation tonometry

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Colorado

University of Colorado Eye Center

Aurora, Colorado, United States, 80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

• Principal Investigator: Malik Y. Kahook, MD; Rocky Mountain Lions Eye Institute

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00478036
• Other Study ID Numbers: 06-1251
• First Posted: May 24, 2007
• Results First Posted: October 7, 2016
• Last Update Posted: October 7, 2016
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:

glaucoma; selective laser trabeculoplasty; anterior chamber flare

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Eye Diseases; Prednisolone; Prednisolone acetate; Ketorolac; Ketorolac Tromethamine; Carboxymethylcellulose Sodium; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Laxatives