An interventional study of Latanoprost-Bimatoprost and Bimatoporost-Latanoprost in Glaucoma, Angle-Closure, sponsored by Singapore National Eye Centre. Status unknown at 1 site in Singapore. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2007-12-05.
Sponsored by Singapore National Eye Centre · Not applicable, Interventional, and Treatment
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.
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 either latanoprost or bimatoprost. They will be subjected to a list of tests (details of schedule and procedures in Appendix A) on the baseline day (Day 0) and instructed that the first eye application will start at 8pm on the same day. For 6 weeks, patients assigned to the latanoprost treatment group will administer latanoprost 0.005% in the evening. Patients assigned to the bimatoprost group will administer 0.03% bimatoprost once daily (in the evening). Study visits will be on Day 14 (Visit 2) and Day 42 (Visit 3).
After 6 weeks, patients will be crossed over to the other medication. Patients will undergo exactly the same regimen of examination and clinic visits as in Treatment period I. Study visits will be on Day 56 (Visit 4) and Day 84 (Visit 5).
98 studies on the registry are indexed under Glaucoma, Angle-Closure; 18 are open to participants now.
This study's planned enrollment of 60 is close to the median of 59 across 61 interventional studies indexed under Glaucoma, Angle-Closure.
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Exclusion Criteria:
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.
Drug: Latanoprost-Bimatoprost
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.
Drug: Bimatoporost-Latanoprost
latanoprost 0.005% once daily followed by bimatoprost 0.03%
Also known as: Xalatan, Lumigan
bimatoprost 0.03% once daily followed by latanoprost 0.005%
Also known as: Xalatan, Lumigan
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
Incidence of side effects of each medication.
Time frame: 6 weeks after each treatment period
This study is status unknown, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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Singapore National Eye Centre