24-hr IOP With Travoprost/Timolol Compared With Latanoprost/Timolol in XFG

Glaucoma Clinical Trial

Official title:

24-hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757835
• Other study ID #: A6219
• Status: Completed
• Phase: Phase 4
• Start date: May 2008
• Est. completion date: March 2009

Study information

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

Clinical Trial Summary

A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patient has XFG and is older than 29 years

• The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)

• Patient can be safely washed out without risk for significant deterioration

• Distance best corrected Snelen visual acuity better than 0.1

• No contraindication to prostaglandins or ß-blockers

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

• Patient can understand the instructions and comply to medications

• Open normal appearing angles

• No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc

Exclusion Criteria:

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

• Patient is a female of childbearing potential or lactating mother

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• treatment with latanoprost/timolol fixed combination
dosing in the evening with the two fixed combinations
• latanoprost/timolol fixed combination drops
once in the evening

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	Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol		3 months
Secondary	Incidence of side effects with the two medications		3 months