Betaxolol clinical studies

Betaxolol
BETOPTIC® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Clinical Trials on Betaxolol
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Clinical Studies

Optic nerve head damage and visual field loss are the result of a sustained elevatedintraocular pressure and poor ocular perfusion. BETOPTIC Ophthalmic Solution has the action of reducing elevated as well as normalintraocular pressure, and the mechanism of ocular hypotensive action appears to be a reduction of aqueous production as demonstrated by tonography and aqueous fluorophotometry. The onset of action with BETOPTIC Ophthalmic Solution can generally be noted within 30 minutes and the maximal effect can usually be detected 2 hours after topical administration. A single dose provides a 12-hour reduction inintraocular pressure. Clinical observation of glaucoma patients treated with BETOPTIC Ophthalmic Solution for up to three years shows that theintraocular pressure lowering effect is well maintained.

Clinical studies show that topical BETOPTIC Ophthalmic Solution reduces meanintraocular pressure 25% from baseline. In trials using 22 mmHg as a generally accepted index ofintraocular pressure control, BETOPTIC Ophthalmic Solution was effective in more than 94% of the population studied, of which 73% were treated with the beta blocker alone. In controlled, double-masked studies, the magnitude and duration of the ocular hypotensive affect of BETOPTIC Ophthalmic Solution and ophthalmic timolol solution were clinically equivalent.

BETOPTIC Ophthalmic Solution has also been used successfully in glaucoma patients who have undergone a laser trabeculoplasty and have needed additional long-term ocular hypotensive therapy.

BETOPTIC Ophthalmic Solution has been well tolerated in glaucoma patients wearing hard or soft contact lenses and in aphakic patients.

BETOPTIC Ophthalmic Solution does not produce miosis or accommodative spasm which are frequently seen with miotic agents. The blurred vision and night blindness often associated with standard miotic therapy are not associated with BETOPTIC Ophthalmic Solution. Thus, patients with central lenticular opacities avoid the visual impairment caused by a constricted pupil.