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

NCT00397241 | Completed Phase 4

• 1 other identifier: A733
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Open-angle Glaucoma

Outcome Measures

Primary Outcomes (2)

• 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).

Interventions

Drug: dorzolamide/timolol DRUG

Drug: latanoprost/timolol DRUG

dorzolamide/timolol and latanoprost DRUG

placebo (artificial tears) DRUG

Eligibility Criteria

• Age: 29 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Glaucoma Unit, A University Dept of Ophthalmology

Thessaloniki, 546 43, Greece

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

dorzolamide-timolol combination; Latanoprost; Timolol; dorzolamide; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Anastasios GP Konstas, MD, PhD

  Glaucoma Unit, A University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Ophthalmology

Study Record Dates

• First Submitted: November 6, 2006
• First Posted: November 8, 2006
• Study Start: September 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: December 19, 2020

Record last verified: 2020-12

Locations

GR (1)