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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00478036
First received: May 23, 2007
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

We will compare, in a randomized, prospective, masked and controlled fashion the effect of a nonsteroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure lowering and degree of ocular inflammation following selective laser trabeculoplasty treatment for open angle glaucoma.


Condition Intervention
Open Angle Glaucoma
Drug: Acular LS
Drug: Pred Forte
Other: Refresh Tears

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Patient Discomfort, Degree of Intraocular Pressure Lowering, and Degree of Ocular Inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: May 2007
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo Comparator: Refresh Tears
Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
Other: Refresh Tears
Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 IOP lowering by SLT 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478036

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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00478036     History of Changes
Other Study ID Numbers: 06-1251
Study First Received: May 23, 2007
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
glaucoma
selective laser trabeculoplasty
anterior chamber flare

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Ocular Hypertension
Ketorolac
Ketorolac Tromethamine
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 27, 2014