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NCT00643669 Clinical Trial

24 Hour IOP Lowering Efficacy of AL-3789

Open-angle Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00643669
Other study ID # C-07-65
Secondary ID
Status Completed
Phase Phase 2
First received March 24, 2008
Last updated November 27, 2012
Start date February 2008

Study information
Verified date November 2012
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AL-3789 Sterile Suspension
Single administration by anterior juxtascleral depot

Locations
Country Name City State
United States Inglewood Inglewood California

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Intraocular Pressure (IOP) Day 28, Up to 24 hours No
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