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OpenTrials
Completed

NCT Number: NCT00757835

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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

treatment with latanoprost/timolol fixed combination

Drug

dosing in the evening with the two fixed combinations

latanoprost/timolol fixed combination drops

Drug

once in the evening

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

  1. Incidence of side effects with the two medications

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • Alcon Research

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 23, 2008
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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