The purpose of this study is to compare the safety and IOP-lowering efficacy of various AL-6221 formulations in patients with open-angle glaucoma or ocular hypertension

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: AL-6221
  • Comparison of safety and IOP lowering efficacy of different concentrations of AL-6221 with that of TRAVATAN
• Drug: TRAVATAN QD
  • Comparison of safety and IOP lowering efficacy of different concentrations of TRAVATAN with that of AL-6221
• Drug: Placebo
  • Vehicle

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • AL-6221 0.0008% BID
• Experimental: 2
  • AL-6221 0.001% BID
• Experimental: 3
  • AL-6221 0.0012% BID
• Active Comparator: 4
  • TRAVATAN QD
• Placebo Comparator: 5
  • Vehicle

Primary Measures

• Mean IOP
  • Time Frame: From baseline
    Safety Issue?: Yes

Inclusion Criteria:

• Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension

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/NCT00637130

Study ID Number: C-06-11

ClinicalTrials.gov Identifier: NCT00637130

Health Authority: United States: Food and Drug Administration