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

ISRCTN	ISRCTN67123277
DOI	https://doi.org/10.1186/ISRCTN67123277
Secondary identifying numbers	N/A

Submission date: 18/07/2007
Registration date: 08/08/2007
Last edited: 09/08/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Luciano Quaranta
Scientific

Centro per lo studio del glaucoma
Piazzale Spedali Civili 1
Brescia
25123
Italy

Phone	+39 (0)30 3995 847
Email	quaranta@med.unibs.it

Study information

Study design	Randomized, observer-masked, two-treatment, two-period cross-over study.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	To evaluate the short-term effect of Timolol-Dorzolamide Fixed Combination (TDFC), and latanoprost 0.005% on the 24-hour Intraocular Pressure (IOP), ambulatory Blood Pressure (BP), and Diastolic Ocular Perfusion Pressure (DOPP), in newly-diagnosed Primary Open-Angle Glaucoma (POAG) patients.
Ethics approval(s)	Institutional Review Board of Clinica Oculistica Università degli studi Brescia (ref: 02/2005/03)
Health condition(s) or problem(s) studied	Primary open-angle glaucoma
Intervention	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 once in the evening (20:00). Twenty-four hour IOP and ambulatory BP were measured at the beginning after the interim washout and at the end of each treatment period, thus obtaining 4 circadian curves. At the time of 24-hour IOP and BP assessments patients were hospitalized, and the drugs were administered by the dosing coordinator of the study according to the protocol. The IOP was measured every two hours. A calibrated Goldmann applanation tonometer (Haag-Streit, Switzerland) was employed to measure sitting IOP at the slit lamp between 08:00 and 22:00, while supine IOP was measured between 24:00 and 06:00, with the patient in bed, by means of a calibrated handheld electronic tonometer (TonoPen XL; 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, Saitama, Japan). Ambulatory BP monitoring units indirectly measure BP through oscillometric measurement of the vibratory signals associated with blood flow in the brachial artery. The BP device satisfies the recommendation by the British Hypertension Society and Association for Advancement of Medical Instrumentation on accuracy levels for both systolic and diastolic blood pressures. A cuff of appropriate size was placed in the subjects non-dominant arm and BP measurements were taken automatically every 15 minutes between 08:00 to 22:00, and every 30 minutes from 22:00 to 08:00. If a certain reading was not performed properly the device was programmed to repeat it. The recorded BP values throughout the 24-hour period were later recovered from the recording chip and stored in a personal computer. During the study BP and IOP readings were monitored in the hospital on two separate days, so as to not influence BP readings by the process of IOP measurements, or by waking the patient during the night for IOP evaluation. IOP measurements were performed by three well-trained masked observers who were unaware of the treatment assignments; their agreement was previously tested on a pilot sample of 15 patients, resulting in an intraclass correlation coefficient of 0.97 and 0.99 for Tonopen and Goldmann tonometry, respectively. A comprehensive ocular and systemic examination was performed at baseline and at the conclusion of each phase of the trial, and any ocular or systemic adverse events were noted.
Intervention type	Other
Primary outcome measure	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 outcome measures	Adverse events
Overall study start date	01/01/2005
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	27
Key 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 Shaffers 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
Key exclusion criteria	See inclusion criteria
Date of first enrolment	01/01/2005
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Italy

Study participating centre

Centro per lo studio del glaucoma

Brescia
25123
Italy

Sponsor information

Clinica Oculistica (Italy)
Hospital/treatment centre

Piazzale Spedali Civili 1
brescia
25123
Italy

Phone	+39 (0)30 3995 847
Email	quaranta@med.unibs.it

Funders

Funder type

Government

Ministry of Education, University and Research (Ministero dellUniversità e della Ricerca; MIUR) (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	01/07/2006		Yes	No