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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014