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Circadian intraocular pressure, blood pressure and diastolic ocular perfusion pressure with timolol-dorzolamide fixed combination compared with latanoprost in newly-diagnosed glaucoma patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67123277
Enrollment
27
Registered
2007-08-08
Start date
2005-01-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Primary open-angle glaucoma Cancer Primary open-angle glaucoma

Interventions

Following the monitoring of the baseline or washout IOP and BP all study patients were randomly assigned to receive either one drop of TDFC twice daily (08:00 and 20:00) or one drop of latanoprost onc
Bio-Rad, USA). At each timepoint, the mean of 3 consecutive readings was calculated. Ambulatory blood pressure monitoring was recorded by means of an automated portable BP device, TM-2430 (A&D Co, S

Sponsors

Clinica Oculistica (Italy)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: We enrolled in the present study consecutive newly diagnosed and previously untreated POAG patients who demonstrated typical optic disc excavation and visual field abnormalities. We included POAG patients older than 45 years with no previous history of ocular surgery or laser. Additional inclusion criteria were: 1. Open-angle by gonioscopy (Grade III-IV according to Shaffer?s grading system) 2. Untreated diurnal IOP between 23 and 32 mm Hg (mean of the two highest values recorded in a daytime IOP curve with measurements every 2 hours between 08:00 and 18:00 by a calibrated Goldmann applanation tonometry) 3. Visual acuity 20/40 or better 4. Mean defect >6 dB using the Humphrey 24-2 program (Humphrey Visual Field Analyzer model 745 perimeter, Humphrey Instruments, Inc., USA) 5. No history of allergy to the ingredients of any of the study drugs 6. No history of cardiovascular disease (e.g. arterial hypertension, heart disease, arrhythmia) 7. No concomitant systemic treatment (e.g. beta-blockers, angiotensin-converting enzyme inhibitors) that could modify IOP, or blood pressure. 8. Females were enrolled in the study only if they were postmenopausal or were using contraceptives

Exclusion criteria

Exclusion criteria: See inclusion criteria

Design outcomes

Primary

MeasureTime frame
The following were measured at baseline, and at the end of each treatment period: 1. 24-hour IOP 2. Ambulatory BP 3. Calculated DOPP

Secondary

MeasureTime frame
Adverse events

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026