Status:

COMPLETED

Travoprost/Timolol vs Latanoprost/Timolol Fixed Combination Therapy

Lead Sponsor:

Aristotle University Of Thessaloniki

Conditions:

Glaucoma

Eligibility:

All Genders

29-80 years

Phase:

PHASE4

Brief Summary

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 in...

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

Key Trial Info

Start Date :

January 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2013

Estimated Enrollment :

42 Patients enrolled

Trial Details

Trial ID

NCT01779284

Start Date

January 1 2012

End Date

January 1 2013

Last Update

May 12 2014

Active Locations (1)

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1

Glaucoma Unit, 1st University Department of Ophthalmology

Thessaloniki, Greece, 546 36