Efficacy, safety, and tolerability of preservative-free fixed combination of tafluprost 0.0015%/timolol 0.5% versus concomitant use of the ingredients.

Abstract

PURPOSE:

To compare efficacy, safety, and tolerability of the preservative-free fixed combination (FC) and non-fixed combination (NFC) of tafluprost 0.0015% and timolol 0.5% in patients with open-angle glaucoma or ocular hypertension.

METHODS:

This 6-month, prospective, randomized, double-masked, active-controlled, parallel group, multicenter phase III study was performed in patients with ocular hypertension and open-angle glaucoma with untreated intraocular pressure (IOP) ≥23 and ≤36 mmHg at baseline.

RESULTS:

Four hundred patients washed out from IOP-lowering medication were randomized, 201 received the FC, and 199 received the NFC. Mean time-wise IOP decreases from baseline ranged from -7.3 to -9.1 mmHg (29.6%-34.6%) in the FC and from -7.5 to -9.4 mmHg (30.7%-36.0%) in the NFC arm [per-protocol (PP) dataset, P<0.0001 compared with baseline for both groups]. At month 6, the estimated overall treatment difference (FC-NFC) was 0.308 mmHg (PP dataset, 95% confidence interval from -0.194 to 0.810 mmHg). An IOP decrease ≥30% was achieved in 58.3% and 66.9% of the patients in the FC and NFC groups, respectively (PP dataset; P=0.105); an IOP decrease ≥35% was achieved in 36.6% and 43.1% of patients in the FC and NFC groups, respectively (PP dataset; P=0.297). Patients with ocular adverse events were evenly distributed in both groups. The most common side effect, conjunctival/ocular hyperemia was found in 8% and 5% of patients in the FC and NFC arms, respectively.

CONCLUSIONS:

All measures of IOP reduction for FC of preservative-free tafluprost/timolol were statistically and clinically significant and non-inferior to those of the NFC, throughout the 6-month study period.

• Authors: Gábor Holló, Anton Hommer, Alfonso Antón López, Auli Ropo
• Journal: Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics (J Ocul Pharmacol Ther) Vol. 30 Issue 6 Pg. 468-75 (Aug 2014) ISSN: 1557-7732 [Electronic] United States
• PMID: 24738883 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antihypertensive Agents
• Drug Combinations
• Prostaglandins F
• tafluprost
• Timolol

Topics

• Adult
• Aged
• Aged, 80 and over
• Antihypertensive Agents (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Combinations
• Drug Therapy, Combination
• Female
• Glaucoma, Open-Angle (drug therapy)
• Humans
• Intraocular Pressure (drug effects)
• Male
• Middle Aged
• Ocular Hypertension (drug therapy)
• Prospective Studies
• Prostaglandins F (administration & dosage, adverse effects, therapeutic use)
• Timolol (administration & dosage, adverse effects, therapeutic use)
• Young Adult