Clinical Trial: Comparison of Bimatoprost and Latanoprost in Patients With Chronic Angle-Closure Glaucoma: A Randomized Cross-Over Study
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comparison of Bimatoprost and Lataprost in Patients With Chronic Angle-Closure Glaucoma: A Randomized Cross-Over Study
Brief Summary: This is a randomized observer-masked cross-over study to compare the intraocular pressure (IOP) reducing effect of latanoprost with bimatoprost in subjects with chronic angle closure glaucoma (CACG) with raised IOP. Study subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. The study will be carried out in at least 2 Singapore hospitals.
Detailed Summary:
Study eyes are defined as the eye(s) that fulfil all inclusion criteria but none of the exclusion criteria. The IOP will be measured by Goldmann applanation tonometry. The IOP at every visit will be taken by one examiner (masked) using the same slit lamp and tonometer. Three consecutive readings will be taken at each time and the mean of the three values used in the statistical analysis. The examiner will not be aware of the treatment the patient is on. The scale of the tonometer will be concealed to the examiner, and the IOP value read off by an assistant after the examiner determines the end point of tonometry.
At the Baseline visit and last visit of each Treatment period (Day 0, 42 and 84), IOP will be measured at 9 am and 5 pm. On Day 14 and 56, IOP will be measured only at 9 AM.
Thus, when the IOP is measured in the clinic at 9 AM, approximately 13 hours would have elapsed from the evening dose. This will coincide with the approximate peak effect of bimatoprost and latanoprost. The IOP reading at 5 PM will be the approximate trough for latanoprost and bimatoprost.
The IOP at the end of each Treatment period at 6 weeks (Day 42 and 84) will be utilized as the primary endpoint and a comparison of mean IOPs of the two treatment groups compared with the baseline (Day 0). For those who do not, for any reason, complete the 6-week assessment, their last IOP measure will be carried forward to provide the endpoint. However, the number of such cases within each treatment group will also be reported.
Prior to the trial, all patients will undergo clinical examinations and eye tests to determine eligibility.
After being enrolled into the trial, patients will be randomized to receive e
Sponsor: Singapore National Eye Centre
Current Primary Outcome: The primary endpoint is defined as IOP reduction from baseline measurement (week 0) to the measurement at week 6 at each treatment period. [ Time Frame: 6 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Incidence of side effects of each medication. [ Time Frame: 6 weeks after each treatment period ]
Original Secondary Outcome: Same as current
Information By: Singapore National Eye Centre
Dates:
Date Received: December 4, 2007
Date Started: July 2006
Date Completion: July 2008
Last Updated: December 4, 2007
Last Verified: November 2007
