Back to resultsPhase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients
Primary Purpose
Open-angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AL-12182 0.003% Ophthalmic Solution
AL-12182 Ophthalmic Solution Vehicle
Latanoprost 0.005% Ophthalmic Solution
AL-12182 0.01% Ophthalmic Solution
AL-12182 0.03% Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Open-angle Glaucoma focused on measuring open-angle, glaucoma, ocular, hypertension, POAG
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Placebo Comparator
Active Comparator
Experimental
Experimental
Arm Label
AL-12182 0.003%
AL-12182 Solution Vehicle
Latanoprost
AL-12182 0.01%
AL-12182 0.03%
Arm Description
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Outcomes
Primary Outcome Measures
Mean Intraocular Pressure (IOP)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00069706
Brief Title
Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients
Official Title
Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Ocular Hypertension
Keywords
open-angle, glaucoma, ocular, hypertension, POAG
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-12182 0.003%
Arm Type
Experimental
Arm Description
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Arm Title
AL-12182 Solution Vehicle
Arm Type
Placebo Comparator
Arm Description
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Arm Title
Latanoprost
Arm Type
Active Comparator
Arm Description
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Arm Title
AL-12182 0.01%
Arm Type
Experimental
Arm Description
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Arm Title
AL-12182 0.03%
Arm Type
Experimental
Arm Description
One drop in the study eye(s) once daily at approximately 8 a.m. for 14 days
Intervention Type
Drug
Intervention Name(s)
AL-12182 0.003% Ophthalmic Solution
Intervention Description
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Intervention Type
Other
Intervention Name(s)
AL-12182 Ophthalmic Solution Vehicle
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005% Ophthalmic Solution
Intervention Description
Commercially marketed ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Intervention Type
Drug
Intervention Name(s)
AL-12182 0.01% Ophthalmic Solution
Intervention Description
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Intervention Type
Drug
Intervention Name(s)
AL-12182 0.03% Ophthalmic Solution
Intervention Description
Investigational ophthalmic solution intended for the treatment of open-angle glaucoma or ocular hypertension
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients
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