Safety and IOP Lowering Efficacy of AL-6221

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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...

Brief Summary

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: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • 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

Outcome Measures for this Clinical Trial

Primary Measures

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Alcon Research Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00637130