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Comparison of once- or twice-daily bimatoprost with twice-daily timolol in patients with elevated IOP : a 3-month clinical trial.
Ophthalmology 2001; 108(6):1023-31; discussion 1032O

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.

Authors+Show Affiliations

Department of Ophthalmology, University of California at Davis, Sacramento, California 95817-2307, USA.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11382623

Citation

Brandt, J D., et al. "Comparison of Once- or Twice-daily Bimatoprost With Twice-daily Timolol in Patients With Elevated IOP : a 3-month Clinical Trial." Ophthalmology, vol. 108, no. 6, 2001, pp. 1023-31; discussion 1032.
Brandt JD, VanDenburgh AM, Chen K, et al. Comparison of once- or twice-daily bimatoprost with twice-daily timolol in patients with elevated IOP : a 3-month clinical trial. Ophthalmology. 2001;108(6):1023-31; discussion 1032.
Brandt, J. D., VanDenburgh, A. M., Chen, K., & Whitcup, S. M. (2001). Comparison of once- or twice-daily bimatoprost with twice-daily timolol in patients with elevated IOP : a 3-month clinical trial. Ophthalmology, 108(6), pp. 1023-31; discussion 1032.
Brandt JD, et al. Comparison of Once- or Twice-daily Bimatoprost With Twice-daily Timolol in Patients With Elevated IOP : a 3-month Clinical Trial. Ophthalmology. 2001;108(6):1023-31; discussion 1032. PubMed PMID: 11382623.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of once- or twice-daily bimatoprost with twice-daily timolol in patients with elevated IOP : a 3-month clinical trial. AU - Brandt,J D, AU - VanDenburgh,A M, AU - Chen,K, AU - Whitcup,S M, AU - ,, PY - 2001/5/31/pubmed PY - 2001/6/22/medline PY - 2001/5/31/entrez SP - 1023-31; discussion 1032 JF - Ophthalmology JO - Ophthalmology VL - 108 IS - 6 N2 - 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. SN - 0161-6420 UR - https://www.unboundmedicine.com/medline/citation/11382623/Comparison_of_once__or_twice_daily_bimatoprost_with_twice_daily_timolol_in_patients_with_elevated_IOP_:_a_3_month_clinical_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(01)00584-X DB - PRIME DP - Unbound Medicine ER -