Original article
A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure:: A 12-week, randomized, masked-evaluator multicenter study

https://doi.org/10.1016/S0002-9394(03)00098-9Get rights and content

Abstract

Purpose

To Internet Advance publication at ajo.com Feb 13, 2003. compare the intraocular pressure (IOP)-lowering effect and safety of latanoprost, bimatoprost, and travoprost in patients with open-angle glaucoma (OAG) or ocular hypertension (OH).

Design

Interventional study.

Methods

This 12-week, randomized, parallel-group study was conducted at 45 US sites. Previously treated patients with OAG or OH and an IOP ≥23 mm Hg in one or both eyes after washout received either latanoprost 0.005%, bimatoprost 0.03%, or travoprost 0.004% once daily in the evening. At baseline and after 6 and 12 weeks of therapy, masked evaluators measured IOP in triplicate at 8:00 am, 12 noon, 4:00 pm, and 8:00 pm, and masked investigators graded conjunctival hyperemia before the 8:00 am IOP measurement. The primary efficacy outcome measure was change between baseline and Week 12 in the 8:00 am IOP (time of peak drug effect).

Results

In all, 410 of 411 randomized patients were included in intent-to-treat analyses (latanoprost, 136; bimatoprost, 136; travoprost, 138). Baseline mean 8:00 am IOP levels were similar (P = .772); by week 12, reductions were observed in all 3 groups (P < .001 for each). Adjusted (ANCOVA) reductions in mean IOP at 8:00 am were similar (P = .128) as were those at 12 noon, 4:00 pm, and 8:00 pm. Fewer latanoprost-treated patients reported ocular adverse events (P < .001, latanoprost vs bimatoprost), fewer reported hyperemia (P = .001, latanoprost vs bimatoprost), and average hyperemia scores were lower at week 12 (P = .001, latanoprost vs bimatoprost).

Conclusions

Latanoprost, bimatoprost, and travoprost were comparable in their ability to reduce IOP in OAG and OH patients. Latanoprost exhibited greater ocular tolerability.

Section snippets

Setting

This 12-week, randomized, parallel-group, masked-evaluator study conducted at 45 sites in the United States compared the efficacy and safety of once daily administration of three commercially available prostaglandin analogues: latanoprost 0.005%, bimatoprost 0.03%, and travoprost 0.004% ophthalmic solutions. Regulatory authorities at each study site reviewed and approved the protocol in accordance with guidelines for the conduct of clinical research contained in the 1964 Declaration of Helsinki.

Patient disposition and demographics

In all, 514 patients were screened; 1 patient was excluded at the week 2 safety check because of an elevated IOP. Following enrollment at baseline, 411 patients were randomized to three treatment groups: latanoprost (n = 136), bimatoprost (n = 137), and travoprost (n = 138) (Figure 2). One patient in the bimatoprost group received medication but had no postbaseline evaluation and was excluded from ITT analyses. The resulting ITT population comprised 410 patients of whom 172 (42.0%) were male,

Discussion

We believe that this is the first randomized, controlled trial simultaneously comparing the IOP-lowering efficacy and safety of latanoprost, bimatoprost, and travoprost. Over 12 weeks, we found no significant differences in efficacy among the three medications in patients with open-angle glaucoma or ocular hypertension using an ITT analysis; results were supported by findings of per-protocol analyses. At the conclusion of the study, IOP measurements were significantly reduced from baseline for

Appendix

Members of the XLT Study Group: Stacey Ackerman, MD, Willingboro, NJ; Louis Alpern, MD, El Paso, TX; Charles Beischel, MD, Charleston, SC; Richard Bennion, MD, Wenatchee, WA; M. Ellen Berg, MD, Shreveport, LA; Bruce Bodner, MD, Virginia Beach, VA; W. Benton Boone, MD, Inglewood, CA; James Branch, MD, Winston-Salem, NC; Carl Camras, MD, Omaha, NE; Neil Choplin, MD, San Diego, CA; William Christie, MD, Pittsburgh, PA; Lawrence Cooper, MD, San Diego, CA; Douglas Day, MD, Atlanta, GA; Jonathan

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