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NCT00348062 Clinical Trial

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

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00348062
Other study ID # 5177
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2006
Last updated May 30, 2007

Study information
Verified date May 2007
Source Innovative Medical
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Bimatoprost

Locations
Country Name City State
United States Dr. Noecker Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

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