12-Month Stability of Diurnal IOP Control on Cosopt

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthony D. Realini, West Virginia University
ClinicalTrials.gov Identifier:
NCT00379834
First received: September 21, 2006
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

To determine the stability of diurnal intraocular pressure in eyes with glaucoma treated with Cosopt


Condition Intervention Phase
Glaucoma
Drug: Cosopt
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 12-Month Stability of Diurnal IOP Control on Cosopt

Resource links provided by NLM:


Further study details as provided by West Virginia University:

Primary Outcome Measures:
  • Diurnal IOP control [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cosopt
Cosopt BID OU
Drug: Cosopt
Cosopt BID OU

Detailed Description:

Glaucoma is a potentially-blinding but treatable eye disease. A major risk factor for glaucoma is elevated intraocular pressure (IOP). IOP is a dynamic variable (like blood pressure)—it changes over time. The more it changes, the more likely patients are to get worse. Glaucoma is treated by lowering IOP. Cosopt is a medication that lowers IOP. Little is known about how well Cosopt reduces IOP fluctuations. In this study, we plan to measure the IOP in both eyes of 10 glaucoma patients treated with Cosopt, every 2 hours from 8am to 8pm, on five separate days over a one-year period. Untreated baseline IOP will be measured on a similar long day before beginning treatment with Cosopt. This methodology will allow us to compare IOP fluctuations with and without Cosopt, and also to learn about long-term control of IOP fluctuations in eyes treated with Cosopt.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bilateral OAG

Exclusion Criteria:

  • contraindications to Cosopt
  • pathology affecting tonometry
  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: NCT00379834

Sponsors and Collaborators
West Virginia University
Investigators
Principal Investigator: Anthony D Realini, MD West Virginia University
  More Information

No publications provided

Responsible Party: Anthony D. Realini, Associate Professor, West Virginia University
ClinicalTrials.gov Identifier: NCT00379834     History of Changes
Other Study ID Numbers: 31861
Study First Received: September 21, 2006
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by West Virginia University:
glaucoma
diurnal
intraocular pressure

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 26, 2014