24-hour IOP-lowering Effect of 0.01% 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: May 19, 2014
Last verified: May 2014
  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
Intraocular Pressure
Glaucoma
Ocular Hypertension
Drug: 0.01% bimatoprost
Phase 4

Study Type: Interventional
Study Design: 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:


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

Primary Outcome Measures:
  • Nocturnal Intraocular Pressure (IOP) Change [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Nocturnal IOP means under bimatoprost 0.01% treatment were compared with baseline.


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
bimatoprost 0.01% one time per day at bedtime for 4 weeks.
Drug: 0.01% bimatoprost
0.01% bimatoprost once in the evening for 4 weeks
Other Name: Lumigan 0.01%

Detailed Description:

Objectives To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (IOP) and ocular perfusion pressure (OPP).

Design Prospective, open-label experimental study.

Setting Single tertiary ophthalmic clinic.

Participants Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (ages, 49-77 years).

Interventions Baseline data of 24 h IOP in untreated patients were collected in a sleep laboratory. Measurements of IOP were taken using a pneumatonometer every 2 h in the sitting and supine body positions during the 16 h diurnal/wake period and in the supine position during the 8 h nocturnal/sleep period. After baseline measurements were taken, patients were treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h IOP data were collected under the same laboratory conditions.

Primary outcome measure of nocturnal IOP mean under bimatoprost 0.01% treatment was compared with baseline.

  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
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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
Investigators
Principal Investigator: John Liu, PhD University of California, San Diego
  More Information

Additional Information:
Publications:
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
Results First Received: December 17, 2013
Last Updated: May 19, 2014
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 July 22, 2014