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24-hour Effect of Bimatoprost

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Liu, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01271686
First received: January 6, 2011
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
  Purpose

This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension


Condition Intervention Phase
24-hour
Intraocular Pressure
Glaucoma
Ocular Hypertension
 Drug: 0.01% bimatoprost
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 24-hour IOP-lowering Effect of 0.01% Bimatoprost

Resource links provided by NLM:

Drug Information available for: Bimatoprost
U.S. FDA Resources

Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • mean IOP for 24-hour period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.01% bimatoprost Drug: 0.01% bimatoprost
0.01% bimatoprost once in the evening for 4 weeks
Other Name: Lumigan 0.01%

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Women of childbearing potential previous glaucoma surgery presence of other eye disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271686

Locations
United States, California
UCSD Shiley Eye Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
  More Information

No publications provided

Responsible Party: John Liu, PhD, Adjunct Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01271686     History of Changes
Other Study ID Numbers: UCSD 101705 bimatoprost
Study First Received: January 6, 2011
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013