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Clinical Trial
. 2003 Jan;87(1):57-62.
doi: 10.1136/bjo.87.1.57.

A randomised, double masked, multicentre clinical trial comparing bimatoprost and timolol for the treatment of glaucoma and ocular hypertension

S M Whitcup  1 , L B Cantor, A M VanDenburgh, K Chen
Affiliations
Clinical Trial

A randomised, double masked, multicentre clinical trial comparing bimatoprost and timolol for the treatment of glaucoma and ocular hypertension

S M Whitcup et al. Br J Ophthalmol. 2003 Jan.

Abstract

Aim: To evaluate the safety and efficacy of bimatoprost 0.03% once daily or twice daily compared with timolol 0.5% twice daily in patients with glaucoma or ocular hypertension.

Methods: Multicentre, double masked, randomised, parallel group, 3 month trial comparing bimatoprost once daily (n=240), bimatoprost twice daily (n=240), and timolol twice daily (n=122). The primary efficacy end point was diurnal intraocular pressure (IOP) (8 am, 10 am, 4 pm). Safety measures included adverse events, ocular parameters, and systemic variables.

Results: Bimatoprost once daily provided significantly lower mean IOP than timolol twice daily at all times and follow up visits (p<0.001). At month 3, mean IOP reductions from baseline at 10 am (peak timolol effect) were bimatoprost once daily, 8.0 mm Hg (32.4%); bimatoprost twice daily, 6.3 mm Hg (25.2%); timolol, 5.5 mm Hg (22.7%). Bimatoprost twice daily was also more effective than timolol, but was not as effective as bimatoprost once daily. A higher percentage of patients achieved low target pressures with bimatoprost once daily than with timolol. The most frequent side effects with bimatoprost were eyelash growth and mild conjunctival hyperaemia. Systemic safety parameters were not affected by bimatoprost.

Conclusions: Bimatoprost 0.03% once daily demonstrated superior efficacy compared with timolol 0.5% twice daily in patients with elevated IOP. Bimatoprost once daily was more effective than twice daily dosing.

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Figures

Figure 1
Figure 1
Mean IOP at 10 am at baseline and follow up study visits. Mean IOP with bimatoprost once daily was consistently significantly lower than with timolol or bimatoprost twice daily at follow up visits. *p<0.001 v timolol and bimatoprost twice daily.
Figure 2
Figure 2
Diurnal mean IOP at month 3. Mean IOP was significantly lower with bimatoprost once daily than with timolol at 8 am, 10 am, and 4 pm. Mean IOP in the bimatoprost twice daily group was significantly lower than in the timolol group at 8 am and 4 pm. Smaller sample sizes at 8 pm resulted in inadequate power for pairwise statistical comparisons. *p<0.001 v timolol and bimatoprost twice daily; †p≤0.048 v timolol; ‡Only measured at selected sites.
Figure 3
Figure 3
Response rates. The percentage of patients that achieved target IOP levels at 10 am is shown for the month 3 visit.
See this image and copyright information in PMC

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