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: February 27, 2014
Last verified: February 2014

May 23, 2007
February 27, 2014
May 2007
January 2014   (final data collection date for primary outcome measure)
Patient Discomfort, Degree of Intraocular Pressure Lowering, and Degree of Ocular Inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00478036 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Open Angle Glaucoma
  • Drug: Acular LS
    Details covered in arm description
  • Drug: Pred Forte
    Details covered in arm description
  • Other: Refresh Tears
    Placebo
  • Active Comparator: Acular LS
    Acular LS - 1 drop in treated eye, 4 times a day, for 4 days
    Intervention: Drug: Acular LS
  • Active Comparator: Pred Forte
    Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days
    Intervention: Drug: Pred Forte
  • Placebo Comparator: Refresh Tears
    Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
    Intervention: Other: Refresh Tears
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00478036
06-1251
No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Malik Y. Kahook, MD Rocky Mountain Lions Eye Institute
University of Colorado, Denver
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP