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24 Hour IOP Lowering Efficacy of AL-3789

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ClinicalTrials.gov Identifier: NCT00643669
Recruitment Status : Completed
First Posted : March 26, 2008
Last Update Posted : November 29, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The objective of this study was to describe the intraocular pressure-lowering efficacy of AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP was measured every 4 hours, beginning at 8 AM for 24 hours.

Condition or disease Intervention/treatment Phase
Open-angle Glaucoma Drug: AL-3789 Sterile Suspension Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2008
Primary Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AL-3789
AL-3789 Sterile Suspension, single depot administration of 0.8 mL in the study eye
Drug: AL-3789 Sterile Suspension
Single administration by anterior juxtascleral depot
No Intervention: No treatment
Fellow eye, as randomized

Primary Outcome Measures :
  1. Mean Intraocular Pressure (IOP) [ Time Frame: Day 28, Up to 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of open-angle glaucoma and treated for at least 30 days prior to Screening Visit with a topical prostaglandin analog as monotherapy.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Pregnant, intend to become pregnant, breastfeeding.
  • Difference in IOP greater than 3 mm Hg between eyes at Screening Visit.
  • Any form of glaucoma other than open-angle glaucoma.
  • Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643669

United States, California
Inglewood, California, United States, 90301
Sponsors and Collaborators
Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00643669     History of Changes
Other Study ID Numbers: C-07-65
First Posted: March 26, 2008    Key Record Dates
Last Update Posted: November 29, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases