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Completed

NCT Number: NCT00397241

24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations

The primary objective of this crossover trial is to compare the 3-month mean 24-hour intraocular pressure (IOP) control and safety of dorzolamide/timolol fixed combination (DTFC) given twice daily, versus latanoprost/timolol fixed combination (LTFC) given in the evening and placebo given in the morning, versus adjunctive therapy with DTFC given twice daily and latanoprost 0.005% given once in the evening in open-angle glaucoma patients who are insufficiently controlled with latanoprost monotherapy.

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Key information

Age range

29 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Glaucoma Unit, A University Dept of Ophthalmology

Thessaloniki, 546 43, Greece

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consecutive primary open-angle (POAG) and exfoliative glaucoma (XFG) patients will be recruited.
  • Patients included will be older than 29 years
  • Have early to moderate POAG, or XFG (less than 12 mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio)
  • Will be on therapy with latanoprost for more than 3 months;
  • Have at treated baseline IOP at 10:00 (two consecutive readings) greater than 21 mm Hg
  • Have a reliable visual field (at least two visual fields with less than 30% fixation losses, false positives or negatives)
  • Have a best corrected distance Snellen visual acuity > 1/10
  • Have corneal pachymetry within the 550 ± 55 μm range, understand the study instructions and are willing to attend all follow-up appointments
  • Are willing to comply with study medication usage
  • And have open, normal appearing angles

Exclusion criteria

  • Patients will be excluded if they have: a risk for significant deterioration during the study
  • Known previous history of lack of adequate response (< 10% reduction) to any topical glaucoma medication
  • Less than 20% daytime IOP reduction on latanoprost;
  • Systemic contraindications to topical beta-blockers (asthma, bradycardia, severe congestive heart disease)
  • Known contraindications to prostaglandins, history of ocular herpetic disease, or cystoid macular edema
  • History of trauma, inflammation, surgery or past use of steroids (within two months)
  • Severe dry eyes
  • Use of contact lenses
  • Signs of ocular infection, except blepharitis
  • Corneal abnormality that may affect IOP measurements
  • Unwillingness to accept the risk for hyperchromia of the iris or development of hypertrichosis
  • And females of childbearing potential or lactating mothers

Treatment and study plan

Drug: dorzolamide/timolol

Drug

Drug: latanoprost/timolol

Drug

dorzolamide/timolol and latanoprost

Drug

placebo (artificial tears)

Drug

Primary outcomes

  1. 24-hour IOP control with DTFC will be statistically similar with LTFC given once each evening and placebo in the morning.

  2. Adjunctive therapy with DTFC and latanoprost will provide significantly better 24-hour IOP control than both fixed combinations alone (DTFC and LTFC).

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Official study title

24-hour IOP With DTFC and LTFC Monotherapies and the Adjunctive Therapy of DTFC and Latanoprost in Open-angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 8, 2006
Registry last updated
Dec 19, 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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