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

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ClinicalTrials.gov Identifier: NCT00069706
Recruitment Status : Completed
First Posted : October 6, 2003
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

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.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Ocular Hypertension 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 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-angle Glaucoma or Ocular Hypertension Patients
Study Start Date : July 2003
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Mean Intraocular Pressure (IOP)


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00069706     History of Changes
Other Study ID Numbers: C-03-25
First Posted: October 6, 2003    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

Keywords provided by Alcon Research:
open-angle
glaucoma
ocular
hypertension
POAG

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Latanoprost
Antihypertensive Agents