Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients

The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: AL-12182 0.003% Ophthalmic Solution; Other: AL-12182 Ophthalmic Solution Vehicle; Drug: Latanoprost 0.005% Ophthalmic Solution; Drug: AL-12182 0.01% Ophthalmic Solution; Drug: AL-12182 0.03% Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older.
• Diagnosis of open-angle glaucoma or ocular hypertension.
• LogMAR visual acuity not worse than 0.6.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Clinically relevant ophthalmic or systemic conditions.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AL-12182 0.003%; One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days	Drug: AL-12182 0.003% Ophthalmic Solution; Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Placebo Comparator: AL-12182 Solution Vehicle; One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days	Other: AL-12182 Ophthalmic Solution Vehicle; Placebo
Active Comparator: Latanoprost; One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days	Drug: Latanoprost 0.005% Ophthalmic Solution; Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Experimental: AL-12182 0.01%; One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days	Drug: AL-12182 0.01% Ophthalmic Solution; Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Experimental: AL-12182 0.03%; One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days	Drug: AL-12182 0.03% Ophthalmic Solution; Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean Intraocular Pressure (IOP)

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): October 1, 2003
• Study Completion (Actual): October 1, 2003

Study Registration Dates

• First Submitted: September 30, 2003
• First Submitted That Met QC Criteria: October 3, 2003
• First Posted (Estimate): October 6, 2003

Study Record Updates

• Last Update Posted (Estimate): February 14, 2012
• Last Update Submitted That Met QC Criteria: February 11, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: POAG; hypertension; glaucoma; open-angle; ocular
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Ophthalmic Solutions; Pharmaceutical Solutions; Latanoprost
• Other Study ID Numbers: C-03-25