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”

The purpose of the study is to compare the safety and IOP-lowering efficacy of AL-37807, 1% vs. Timolol Gel Forming Solution, 0.5% vs. Vehicle all dosed QD AM, all dosed concomitantly with Xalatan QD PM in patients with open-angle glaucoma or ocular hypertension

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

Intervention(s) in this Clinical Trial

• Drug: AL-37807
  • Active drug

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • AL-37807
• Active Comparator: 2
  • Timolol Gel Forming Solution
• Placebo Comparator: 3
  • Vehicle

Primary Measures

• Mean IOP change from baseline
  • Time Frame: from baseline
    Safety Issue?: Yes

Inclusion Criteria:

• open-angle glaucoma
• ocular hypertension
• Must have been on Xalatan for at least 3 months
• VA not worse than 0.60

Exclusion Criteria:

• Age related

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Alcon Research

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620256

Study ID Number: C-07-05

ClinicalTrials.gov Identifier: NCT00620256

Health Authority: United States: Food and Drug Administration