24 Hour IOP Lowering Efficacy of AL-3789

Phase 2

Completed

• Conditions: Open-angle Glaucoma
• Interventions: Drug: AL-3789 Sterile Suspension

• Registration Number: NCT00643669
• Lead Sponsor: Alcon Research

Brief Summary

The objective of this study was to describe the intraocular pressure-lowering efficacy of AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP was measured every 4 hours, beginning at 8 AM for 24 hours.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-24
• Study First Submitted QC: 2008-03-24
• Study First Posted: 2008-03-26
• Primary Completion: 2008-04
• Status Verified: 2012-11
• Disposition First Submitted: 2012-11-27
• Disposition First Submitted QC: 2012-11-27
• Last Update Submitted: 2012-11-27
• Disposition First Posted: 2012-11-29
• Last Update Posted: 2012-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Diagnosis of open-angle glaucoma and treated for at least 30 days prior to Screening Visit with a topical prostaglandin analog as monotherapy.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Pregnant, intend to become pregnant, breastfeeding.
• Difference in IOP greater than 3 mm Hg between eyes at Screening Visit.
• Any form of glaucoma other than open-angle glaucoma.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AL-3789	AL-3789 Sterile Suspension	AL-3789 Sterile Suspension, single depot administration of 0.8 mL in the study eye

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP)	Day 28, Up to 24 hours

Trial Locations

Locations (1)

Inglewood; 🇺🇸 Inglewood, California, United States