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CompletedNCT00397241Updated Dec 19, 2020

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

A Phase 4 interventional study of Drug: dorzolamide/timolol and Drug: latanoprost/timolol in Open-angle Glaucoma, sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 29 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-19.

Sponsored by Aristotle University Of Thessaloniki · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
29 Years to 80 Years
Sex
All
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Study summary

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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Conditions studied

  • Open-angle Glaucoma
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In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 33 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Aristotle University Of Thessaloniki is the lead sponsor of 274 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
29 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
33 participants (actual)

Interventions

  • DrugDrug: dorzolamide/timolol
  • DrugDrug: latanoprost/timolol
  • Drugdorzolamide/timolol and latanoprost
  • Drugplacebo (artificial tears)
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What researchers measure

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).

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Study locations

1 site
  • Glaucoma Unit, A University Dept of Ophthalmology
    Thessaloniki, 546 43, Greece
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00397241
Lead sponsor
Aristotle University Of Thessaloniki
Responsible party
AGP Konstas (Professor in Ophthalmology, Aristotle University Of Thessaloniki) — Principal investigator
First posted
Nov 8, 2006
Start date
Sep 2006
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Dec 19, 2020

Study contacts

Anastasios GP Konstas, MD, PhD
principal investigator · Glaucoma Unit, A University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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