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Adjunctive Study of AL-37807 Ophthalmic Suspension

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Open-Angle Glaucoma; Ocular Hypertension

Intervention: AL-37807 ophthalmic suspension, 0.1% (Drug); Timolol gel forming solution, 0.5% (Drug); AL-37807 ophthalmic solution vehicle (Other); Latanoprost ophthalmic solution (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Alcon Research

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean change from baseline in intraocular pressure

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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

Starting date: November 2007
Last updated: December 3, 2012

Page last updated: August 23, 2015

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