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

NCT00757835 | Completed Phase 4

• 1 other identifier: A6219
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glaucoma

Keywords

24-hour IOP; exfoliative glaucoma; travoprost/timolol; latanoprost/timolol; fixed combinations

Outcome Measures

Primary Outcomes (1)

• Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol

  3 months

Secondary Outcomes (1)

• Incidence of side effects with the two medications

  3 months

Study Arms (2)

Travoprost/timolol therapy

ACTIVE COMPARATOR

treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring.

Drug: treatment with latanoprost/timolol fixed combination; Drug: latanoprost/timolol fixed combination drops

Latanoprost/timolol therapy

ACTIVE COMPARATOR

Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring.

Drug: treatment with latanoprost/timolol fixed combination; Drug: latanoprost/timolol fixed combination drops

Interventions

treatment with latanoprost/timolol fixed combination DRUG

dosing in the evening with the two fixed combinations

Latanoprost/timolol therapy; Travoprost/timolol therapy

latanoprost/timolol fixed combination drops DRUG

once in the evening

Latanoprost/timolol therapy; Travoprost/timolol therapy

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 β-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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Alcon Research: collaborator

MeSH Terms

Conditions

Glaucoma

Interventions

Therapeutics; Latanoprost

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Anastasios G Konstas, MD, PhD

  Glaucoma Unit, 1st University Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Ophthalmology

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 23, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: December 17, 2020

Record last verified: 2020-12