A Multicenter Evaluation of Methods to Reduce Hyperemia Associated With Bimatoprost Therapy for Glaucoma or Ocular Hypertension

This study has been completed.

First Received: June 30, 2006 Last Updated: May 30, 2007 History of Changes

Sponsored by:	Innovative Medical
Information provided by:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT00348062

Purpose

Evaluate the incidence of hyperemia in patients using bimatoprost and to determine if simple interventions reduce its incidence and to assess the value of detailed instruction in increasing patient compliance and willingness to continue bimatoprost therapy, despite the occurrence of hyperemia.

Condition	Intervention	Phase
Glaucoma	Drug: Bimatoprost	Phase IV

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	A Multicenter Evaluation of Methods to Reduce Hyperemia Associated With Bimatoprost Therapy for Glaucoma or Ocular Hypertension

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Bimatoprost

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

· Male or female > 18 years of age
- No prior use of bimatoprost
- Diagnosis of open-angle glaucoma or ocular hypertension
- Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

· Known contraindication to bimatoprost
- Uncontrolled systemic disease
- Active ocular disease other than glaucoma or ocular hypertension
- Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear solutions will be permitted)
- History of intraocular surgery within the last 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348062

Locations

United States, Pennsylvania
Dr. Noecker
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Innovative Medical

Investigators

Principal Investigator:

Robert Noecker, MD

UPMC Eye Center

More Information

No publications provided

Study ID Numbers:	5177
Study First Received:	June 30, 2006
Last Updated:	May 30, 2007
ClinicalTrials.gov Identifier:	NCT00348062 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Hyperemia
Bimatoprost
Glaucoma
Eye Diseases
Vascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Bimatoprost
Glaucoma
Therapeutic Uses
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on September 11, 2009