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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014