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

Alcon

Status and phase: Completed; Phase 2

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: AL-12182 0.03% Ophthalmic Solution; Other: AL-12182 Ophthalmic Solution Vehicle; Drug: AL-12182 0.01% Ophthalmic Solution; Drug: Latanoprost 0.005% Ophthalmic Solution; Drug: AL-12182 0.003% Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00069706

C-03-25

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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118 participants in 5 patient groups, including a placebo group

AL-12182 0.003%

Experimental group

Description:

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Treatment:

Drug: AL-12182 0.003% Ophthalmic Solution

AL-12182 Solution Vehicle

Placebo Comparator group

Description:

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Treatment:

Other: AL-12182 Ophthalmic Solution Vehicle

Latanoprost

Active Comparator group

Description:

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Treatment:

Drug: Latanoprost 0.005% Ophthalmic Solution

AL-12182 0.01%

Experimental group

Description:

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Treatment:

Drug: AL-12182 0.01% Ophthalmic Solution

AL-12182 0.03%

Experimental group

Description:

One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days

Treatment:

Drug: AL-12182 0.03% Ophthalmic Solution