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Adjunctive Study of AL-37807 Ophthalmic Suspension

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AL-37807 ophthalmic suspension, 0.1%
Timolol gel forming solution, 0.5%
AL-37807 ophthalmic solution vehicle
Latanoprost ophthalmic solution
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Glaucoma, Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Contact Alcon Call Center at 1-888-451-3937

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

AL-37807

Timolol

AL-37807 vehicle

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Mean change from baseline in intraocular pressure

Secondary Outcome Measures

Full Information

First Posted
February 11, 2008
Last Updated
December 3, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00620256
Brief Title
Adjunctive Study of AL-37807 Ophthalmic Suspension
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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
Glaucoma, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AL-37807
Arm Type
Experimental
Arm Description
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
Arm Title
Timolol
Arm Type
Active Comparator
Arm Description
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
Arm Title
AL-37807 vehicle
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
AL-37807 ophthalmic suspension, 0.1%
Intervention Type
Drug
Intervention Name(s)
Timolol gel forming solution, 0.5%
Intervention Type
Other
Intervention Name(s)
AL-37807 ophthalmic solution vehicle
Intervention Type
Drug
Intervention Name(s)
Latanoprost ophthalmic solution
Other Intervention Name(s)
XALATAN
Primary Outcome Measure Information:
Title
Mean change from baseline in intraocular pressure
Time Frame
Baseline, up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Contact Alcon Call Center at 1-888-451-3937
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

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Adjunctive Study of AL-37807 Ophthalmic Suspension

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