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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00069706
First received: September 30, 2003
Last updated: February 11, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Latanoprost
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP)

Enrollment: 118
Study Start Date: July 2003
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00069706     History of Changes
Other Study ID Numbers: C-03-25
Study First Received: September 30, 2003
Last Updated: February 11, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
 Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013