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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Drug: Acular LS; Drug: Pred Forte; Other: Refresh Tears

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 Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: CARBOXYMETHYLCELLULOSE SODIUM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interocular Pressure	IOP, measured by Goldmann applanation tonometry	8 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Malik Y. Kahook, MD, Rocky Mountain Lions Eye Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: May 23, 2007
• First Submitted That Met QC Criteria: May 23, 2007
• First Posted (Estimate): May 24, 2007

Study Record Updates

• Last Update Posted (Estimate): October 7, 2016
• Last Update Submitted That Met QC Criteria: August 15, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: glaucoma; selective laser trabeculoplasty; anterior chamber flare
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Laxatives; Prednisolone; Prednisolone acetate; Ketorolac; Ketorolac Tromethamine; Carboxymethylcellulose Sodium
• Other Study ID Numbers: 06-1251

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No