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Comparison of once- or twice-daily bimatoprost with twice-daily timolol in patients with elevated IOP
Abstract
Objective To compare the safety, tolerability, and efficacy of bimatoprost 0.03% instilled once daily or twice daily with timolol 0.5% twice daily. Design Multicenter, 3-month, randomized, double-masked, interventional comparison trial. Participants Patients diagnosed with ocular hypertension or glaucoma (n = 596). Intervention Patients received bimatoprost 0.03% ophthalmic solution once daily (8 PM, with vehicle control at 8 AM), bimatoprost 0.03% twice daily (8 AM; 8 PM), or timolol 0.5% twice daily (8 AM; 8 PM) in an uneven 2:2:1 randomization. Scheduled visits were at prestudy, baseline (day 0), weeks 2 and 6, and month 3. Intraocular pressure (IOP) was measured at 8 AM (predose), 10 AM, and 4 PM. Main outcome measures The primary outcome measure was reduction in IOP in the eye with higher IOP at baseline. Secondary outcome measures included safety variables (adverse events, ophthalmoscopy, biomicroscopy, iris pigmentation, laser-flare meter, visual acuity, visual fields, heart rate, blood pressure, blood chemistry, hematology, and urinalysis). Results At month 3, the mean reduction in IOP from baseline at 8 AM was 9.16 mmHg (35.2%) with bimatoprost once daily, 7.78 mmHg (30.4%) with bimatoprost twice daily, and 6.74 mmHg (26.2%) with timolol twice daily. At all follow-up visits, mean IOP reductions were significantly greater in the bimatoprost once daily group than in the timolol group at each time point (8 AM, 10 AM, and 4 PM; P < 0.001). Twice-daily dosing of bimatoprost also provided significantly greater mean reductions in IOP than timolol at most time points but was not as effective as once-daily dosing. Bimatoprost was associated with significantly more hyperemia and eyelash growth than timolol, whereas timolol was associated with significantly more burning and stinging sensation in eyes. Overall, bimatoprost was well tolerated with few discontinuations because of adverse events. Conclusions Bimatoprost 0.03% once daily was safe and statistically superior to timolol 0.5% twice daily in lowering IOP in patients with ocular hypertension or glaucoma. Bimatoprost given once daily consistently provided IOP reductions approximately 2 to 3 mmHg greater than those provided by timolol. Once-daily dosing of bimatoprost, 0.03%, demonstrated greater IOP-lowering effect and better ocular tolerability than twice-daily dosing.
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“Eyelash growth was noted as an adverse effect of bimatoprost use in clinical trials of patients with glaucoma and ocular hypertension [9, 10, 12, 13], an effect thought to arise by the interaction of bimatoprost with prostamide-sensitive receptors in hair follicles [14].”
From Bimatoprost for Eyelash Growth in Japanese Subjects: Two Multicenter Controlled Studies (2014) · cites this paper as [12]
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Metadata
- Authors
- Brandt, J. D., VanDenburgh, A. M., Chen, K., & Whitcup, S. M.
- Affiliations
- University of California, Davis (US)
- Allergan (United States) (US)
- Corresponding author
- Brandt, James D
- Venue
- Ophthalmology
- Publisher
- Elsevier BV
- Published
- 2001-06
- Volume
- 108
- Issue
- 6
- Pages
- 1023-1031
- ISSN
- 0161-6420 (ISSN-L)
- OpenAlex
- W2138342502
- Cited by
- 152
- References
- 24
- Citations by year
- 2025: 2 · 2023: 2 · 2022: 2 · 2021: 3 · 2020: 4 · 2019: 5 · 2018: 2 · 2017: 6 · 2016: 3 · 2015: 3 · 2014: 6 · 2013: 5 · 2012: 4
- FWCI
- 16.08
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Ophthalmology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Ophthalmology › Glaucoma and retinal disorders
- Health Sciences › Medicine › Ophthalmology › Drug-Induced Ocular Toxicity
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Keywords
- bimatoprost, timolol, intraocular pressure, ocular hypertension, glaucoma, once-daily dosing, twice-daily dosing, beta-blockers, prostamide, hyperemia, eyelash growth, drug safety and tolerability, intraocular pressure reduction, visual acuity, heart rate, blood pressure, adverse events, iris pigmentation
- MeSH terms
- Bimatoprost, Adult, Amides, Antihypertensive Agents, Cloprostenol, Double-Blind Method, Drug Administration Schedule, Female, Glaucoma, Hemodynamics, Humans, Intraocular Pressure, Lipids, Male, Middle Aged, Ocular Hypertension, Ophthalmic Solutions, Safety, Timolol, Visual Acuity, Visual Fields, Treatment Outcome
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