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.

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.

Study Overview

• Status: Completed
• Conditions: Open-angle Glaucoma
• Intervention / Treatment: Drug: Drug: dorzolamide/timolol; Drug: Drug: latanoprost/timolol; Drug: dorzolamide/timolol and latanoprost; Drug: placebo (artificial tears)

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 29 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
24-hour IOP control with DTFC will be statistically similar with LTFC given once each evening and placebo in the morning.
Adjunctive therapy with DTFC and latanoprost will provide significantly better 24-hour IOP control than both fixed combinations alone (DTFC and LTFC).

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Investigators: Principal Investigator: Anastasios GP Konstas, MD, PhD, Glaucoma Unit, A University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2006
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: November 6, 2006
• First Submitted That Met QC Criteria: November 6, 2006
• First Posted (Estimate): November 8, 2006

Study Record Updates

• Last Update Posted (Actual): December 19, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Pharmaceutical Solutions; Ophthalmic Solutions; Timolol; Dorzolamide; Lubricant Eye Drops; Latanoprost
• Other Study ID Numbers: A733