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24 Hour IOP Lowering Efficacy of AL-3789

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00643669
First received: March 24, 2008
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Open-angle Glaucoma
 Drug: AL-3789 Sterile Suspension
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) [ Time Frame: Day 28, Up to 24 hours ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: February 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643669

Locations
United States, California
Inglewood
Inglewood, California, United States, 90301
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00643669     History of Changes
Other Study ID Numbers: C-07-65
Study First Received: March 24, 2008
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013