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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00757835

Enrollment

Registered

2008-09-23

Start date

2008-05-31

Completion date

2009-03-31

Last updated

2020-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

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

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.

Interventions

DRUGtreatment with latanoprost/timolol fixed combination

dosing in the evening with the two fixed combinations

DRUGlatanoprost/timolol fixed combination drops

once in the evening

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 85 Years

Healthy volunteers

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 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

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

Design outcomes

Primary

Measure	Time frame
Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol	3 months

Secondary

Measure	Time frame
Incidence of side effects with the two medications	3 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026