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24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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.

NCT00397241•Aristotle University Of Thessaloniki

View on ClinicalTrials.gov

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.

Eligibility

Age

29 - 80 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (1)

Glaucoma Unit, A University Dept of Ophthalmology

Thessaloniki, Greece

Key Dates

Start Date

September 1, 2006

Primary Completion Date

December 1, 2007

Completion Date

December 1, 2007

Last Updated

December 19, 2020

Enrollment

ACTUAL participants

Conditions

Open-angle Glaucoma

Interventions

Drug: dorzolamide/timolol

DRUG

Drug: latanoprost/timolol

DRUG

dorzolamide/timolol and latanoprost

DRUG

placebo (artificial tears)

DRUG

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

NCT06267274

Open-angle GlaucomaOcular Hypertension

View study

COMPLETEDPHASE3

Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

NCT03850782

Open-Angle GlaucomaOcular Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

PASCAL Trabeculoplasty

PRESERFLO® MicroShunt Extension Study

Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity

Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost