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NCT00761709 Clinical Trial

Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00761709
Other study ID # C-08-28
Secondary ID
Status Completed
Phase Phase 2
First received September 25, 2008
Last updated July 11, 2014
Start date July 2009
Est. completion date October 2009

Study information
Verified date July 2014
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of AL-39256 in patients with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with open-angle glaucoma or ocular hypertension.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Females of childbearing potential.

- Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• AL-39256 Ophthalmic Suspension, 1%

• Latanoprost Ophthalmic Solution, 0.005%

• Vehicle
Inactive ingredients used as a placebo comparator

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change from baseline in IOP Week 4 No
See also
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