Adjunctive Study of AL-37807 Ophthalmic Suspension

December 3, 2012 updated by: Alcon Research

Comparison of Safety and Efficacy of Al-37807 Ophthalmic Suspension vs. Timolol Gel Forming Solution and Vehicle, All Dosed Concomitantly With Xalatan in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center at 1-888-451-3937

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Open-angle glaucoma
  • Ocular hypertension
  • Must have been on Xalatan for at least 3 months
  • VA not worse than 0.60
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Age related
  • Other protocol-defined exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AL-37807
AL-37807 ophthalmic suspension, 0.1%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
Drug: Latanoprost ophthalmic solution
Other Names:
  • XALATAN
Drug: AL-37807 ophthalmic suspension, 0.1%
Active Comparator: Timolol
Timolol gel forming solution, 0.5%, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
Drug: Latanoprost ophthalmic solution
Other Names:
  • XALATAN
Drug: Timolol gel forming solution, 0.5%
Placebo Comparator: AL-37807 vehicle
AL-37807 ophthalmic solution vehicle, one drop in the study eye(s) at 8 AM, with latanoprost ophthalmic solution, one drop in the study eye(s) at 8 PM, for four weeks
Drug: Latanoprost ophthalmic solution
Other Names:
  • XALATAN
Drug: AL-37807 ophthalmic suspension, 0.1%
Other: AL-37807 ophthalmic solution vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in intraocular pressure
Time Frame: Baseline, up to 4 weeks
Baseline, up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

February 11, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Estimate)

December 5, 2012

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-07-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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