[Ocular hypotensive effect of 1% carteolol long-acting eye drops--a double-masked, randomized phase III study in ocular hypertension or primary open-angle glaucoma patients comparing long-acting carteolol eye drops vs. current product].

Abstract

PURPOSE:

To compare the ocular hypotensive activity and safety profile of long-acting 1% carteolol hydrochloride eye drops (long-acting formulation) to those of 1% carteolol hydrochloride eye drops(currently prescribed drug) for reduction of intraocular pressure.

SUBJECTS AND METHODS:

Patients with primary open-angle glaucoma or ocular hypertension (146 cases) were assigned randomly to the long-acting drug group (74 cases) and the currently-prescribed drug group (72 cases). Long-acting eye drops were instilled once a day in the morning (along with one drop of placebo at night), and currently-prescribed eye drops were instilled twice a day in the morning and at night. Eye drops were administered for 8 weeks. Intraocular pressure was monitored at 2, 4, and 8 weeks after the initiation of drug instillation for evaluation of equivalence.

RESULTS:

Intraocular pressure was significantly reduced during the entire follow-up period in both groups. In the long-acting drug group, the reduction of intraocular pressure was--3.5 +/- 0.2,--4.3 +/- 0.2 and--4.6 +/- 0.3 mmHg at 2, 4, and 8 weeks, respectively (paired t test). In the currently-prescribed drug group, the reduction of intraocular pressure was--4.1 +/- 0.2,--4.4 +/- 0.3 and--4.6 +/- 0.2 mmHg at 2, 4, and 8 weeks(paired t test). The safety profile was similar in both groups, and the tolerance for the long-acting eye drops was as good as for the currently-prescribed eye drops.

CONCLUSION:

Because the efficacy of both drugs was equivalent, with an identical safety profile, the long-acting eye drops seem to be an efficacious formulation for clinical use in Japanese glaucoma patients.

• Authors: Tetsuya Yamamoto, Carteolol Long-acting Formulation Study Group
• Journal: Nippon Ganka Gakkai zasshi (Nippon Ganka Gakkai Zasshi) Vol. 111 Issue 6 Pg. 463-72 (Jun 2007) ISSN: 0029-0203 [Print] Japan
• PMID: 17601060 (Publication Type: Clinical Trial, Phase III, Comparative Study, English Abstract, Journal Article, Randomized Controlled Trial)

Chemical References

• Adrenergic beta-Antagonists
• Ophthalmic Solutions
• Carteolol

Topics

• Adrenergic beta-Antagonists (administration & dosage, pharmacology)
• Carteolol (administration & dosage, pharmacology)
• Female
• Glaucoma, Open-Angle (drug therapy)
• Humans
• Intraocular Pressure (drug effects)
• Male
• Middle Aged
• Ocular Hypertension (drug therapy)
• Ophthalmic Solutions (administration & dosage)