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Completed

Phase 4
Age: 29Years - 80Years
All Genders
ID01779284

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

Led by Aristotle University Of Thessaloniki · Updated on 2014-05-12

42

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Brief Title

Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

Who Can Participate

Age: 29Years - 80Years
All Genders

Eligibility Criteria

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

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