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Completed

NCT Number: NCT01779284

Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. It is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

29 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, 546 36, Greece

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary open-angle glaucoma or exfoliative glaucoma
  • Patients who require additional IOP lowering on latanoprost monotherapy
  • Morning IOP greater than 20 mm Hg on latanoprost monotherapy
  • Untreated morning IOP greater than 26 mm Hg
  • Patients older than 29 years
  • Patients with early to moderate glaucoma (less than 14 decibel (dB) mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio)
  • On therapy with latanoprost monotherapy for at least 3 months
  • Patients with a reliable visual field
  • Best corrected distance Snellen visual acuity >1/10
  • Corneal pachymetry within the 550 ± 50 μm range
  • Patients should understand the study instructions
  • Patients willing to attend all follow-up appointments and willing to comply with study medication usage
  • Patients who have open, normal appearing angles

Exclusion criteria

  • History of combined topical therapy
  • Contraindication to prostaglandins or timolol
  • History of ocular trauma or inflammation; intraocular surgery; severe dry eyes; use of contact lenses
  • Sign of ocular infection except for mild blepharitis
  • Any corneal abnormality that could have affected the measurement of IOP
  • Chronic use of topical corticosteroids in the last 3 months before entering the study
  • Current, or previous use of systemic corticosteroid treatment
  • Uncontrolled systemic disease
  • Change of a systemic medication during the study period
  • Women of childbearing potential or lactating mothers
  • Inability to understand the instructions and adhere to medications

Treatment and study plan

Travoprost/timolol therapy

Drug

Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing

Other names: DuoTrav BAK Free

Latanoprost/Timolol therapy

Drug

Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy

Other names: Xalacom

Primary outcomes

  1. Mean 24-hour intraocular pressure reduction between the two medications

    Time frame: 3 months

    Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer

Secondary outcomes

  1. rate of adverse events with the two medications

    Time frame: 3 months

    At each visit local and systemic adverse effects that occurred during the treatment period will be recorded. Adverse events are evaluated by asking patients a general query about their state of health.

  2. ocular surface indicators after 3 months of therapy with the two medications

    Time frame: 3 months

    Selected indicators (break up time of tears, Schirmer test and degree of corneal stain after application of fluorescein) will be employed after 3 months of therapy to determine the health status of ocular surface with the two medications.

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

24-Hour Efficacy of Travoprost/Timolol Benzalkonium Chloride BAK Free Compared With Latanoprost/Timolol Fixed Combination Therapy in Subjects With Open-Angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Jan 30, 2013
Registry last updated
May 12, 2014

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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