12-Month Stability of Diurnal IOP Control on Cosopt

Glaucoma Clinical Trial

Official title:

12-Month Stability of Diurnal IOP Control on Cosopt

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379834
• Other study ID #: 31861
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2006
• Last updated: January 26, 2015
• Start date: September 2006
• Est. completion date: April 2008

Study information

• Verified date: January 2015
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• bilateral open-angle glaucoma

Exclusion Criteria:

• contraindications to Cosopt

• pathology affecting tonometry

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Cosopt
Cosopt twice daily in both eyes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diurnal Intraocular Pressure Control	Change from baseline in mean diurnal IOP (measured every two hours from 8AM to 8PM) averaged across on-treatment study visits (week 1, months 1, 6, 12)	12 months	No