search
Back to results

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

Primary Purpose

Open-angle Glaucoma

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Drug: dorzolamide/timolol
Drug: latanoprost/timolol
dorzolamide/timolol and latanoprost
placebo (artificial tears)
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma

Eligibility Criteria

29 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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
  • Unwillingness to accept the risk for hyperchromia of the iris or development of hypertrichosis
  • And females of childbearing potential or lactating mothers

Sites / Locations

  • Glaucoma Unit, A University Dept of Ophthalmology

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 6, 2006
Last Updated
December 16, 2020
Sponsor
Aristotle University Of Thessaloniki
search

1. Study Identification

Unique Protocol Identification Number
NCT00397241
Brief Title
24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 2006 (Actual)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Drug: dorzolamide/timolol
Intervention Type
Drug
Intervention Name(s)
Drug: latanoprost/timolol
Intervention Type
Drug
Intervention Name(s)
dorzolamide/timolol and latanoprost
Intervention Type
Drug
Intervention Name(s)
placebo (artificial tears)
Primary Outcome Measure Information:
Title
24-hour IOP control with DTFC will be statistically similar with LTFC given once each evening and placebo in the morning.
Title
Adjunctive therapy with DTFC and latanoprost will provide significantly better 24-hour IOP control than both fixed combinations alone (DTFC and LTFC).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasios GP Konstas, MD, PhD
Organizational Affiliation
Glaucoma Unit, A University Department of Ophthalmology, AHEPA Hospital, Thessaloniki, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glaucoma Unit, A University Dept of Ophthalmology
City
Thessaloniki
ZIP/Postal Code
546 43
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs