24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol

Glaucoma Clinical Trial

Official title:

Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With Open-angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981786
• Other study ID #: A434
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2020
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. This comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. The design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient has open-angle glaucoma and is older than 29 years

• Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg

• Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction

• Patient deemed by PI to require adjunctive therapy to obtain desired target IOP

• Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)

• Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less)

• Distance best corrected Snellen visual acuity at least 0.1

• No contraindications to travoprost, brimonidine, brinzolamide and ß-blockers

• No history of lack of response (<10% morning IOP reduction) to any medication

• Patient can understand the instructions and adhere to medications

Exclusion Criteria:

• Female patient of childbearing potential or lactating mother

• History of trauma, inflammation, surgery

• History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses

• Signs of ocular infection, except blepharitis

• Evidence of corneal abnormality that may affect IOP measurements etc

• Closed angle

• History of non-compliance

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Brimonidine/timolol fixed combination drops added to travoprost
twice daily administration
• Brinzolamide/timolol fixed combination drops added to travoprost
twice daily dosing

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-hour intraocular pressure		3 months
Secondary	Fluctuation of 24-hour intraocular pressure		3 months