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Assessing the ability of timolol/dorzolamide eyedrops to modulate the arterial blood flow in patients with glaucoma

Impact of timolol/dorzolamide therapy on autoregulation in glaucoma patients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-004946-13-BE
Enrollment
Unknown
Registered
2013-08-29
Start date
2013-09-30
Completion date
Unknown
Last updated
2014-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary open-angle glaucoma

Interventions

Trade Name: Timoptol 5,0 mg/ml (0,5%) Product Name: Timoptol 5,0 mg/ml (0,5%) Pharmaceutical Form: Eye drops, solution INN or Proposed INN: Timolol CAS Number: 26839-75-8 Other descriptive name: TIMOL

Sponsors

University Hospitals Leuven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients over 18 years old Willing to give a written consent Patient with primary-open angle glaucoma Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: history of ocular trauma intraocular surgery (except for cataract surgery) eye disease associated with hemodynamic disturbances (except glaucoma) systemic diseases with ocular involvement like diabetes contra-indications to the use of topical beta-blockers or carbonic anhydrase inhibitors

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary aim of this study is to determine whether topical glaucoma medications can have an effect on the autoregulation ability by the ocular circulation, as assessed by color Doppler Imaging;Secondary Objective: Not applicable;Primary end point(s): The study aims at identify whether adding dorzolamide to pre-existing timolol therapy can change the resistivity/pulsatility ratio of the retrobulbar arteries in glaucomatous eyes. ;Timepoint(s) of evaluation of this end point: The timepoint for assessing the primary end point would take place at the second study visit (scheduled to take place 4 weeks after the first visit).

Secondary

MeasureTime frame
Secondary end point(s): A change in the overall Doppler waveform (systolic and diastolic mean velocities and early systolic acceleration) of the retrobulbar arteries will also be assessed. ;Timepoint(s) of evaluation of this end point: The timepoint for assessing the primary end point would take place at the second study visit (scheduled to take place 4 weeks after the first visit).

Countries

Belgium

Contacts

Public ContactIngeborg Stalmans

University Hospitals Leuven

ingeborg.stalmans@uzleuven.be+3216332372

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026