Contact information
Type
Scientific
Primary contact
Prof Luciano Quaranta
ORCID ID
Contact details
Centro per lo studio del glaucoma
Piazzale Spedali Civili 1
Brescia
25123
Italy
+39 (0)30 3995 847
quaranta@med.unibs.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
Institutional Review Board of Clinica Oculistica Università degli studi Brescia (ref: 02/2005/03)
Study design
Randomized, observer-masked, two-treatment, two-period cross-over study.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
01/01/2005
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
27
Participant exclusion criteria
See inclusion criteria
Recruitment start date
01/01/2005
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Italy
Trial participating centre
Centro per lo studio del glaucoma
Brescia
25123
Italy
Sponsor information
Organisation
Clinica Oculistica (Italy)
Sponsor details
Piazzale Spedali Civili 1
brescia
25123
Italy
+39 (0)30 3995 847
quaranta@med.unibs.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Ministry of Education, University and Research (Ministero dellUniversità e della Ricerca; MIUR) (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Publication citations
-
Results
Quaranta L, Gandolfo F, Turano R, Rovida F, Pizzolante T, Musig A, Gandolfo E, Effects of topical hypotensive drugs on circadian IOP, blood pressure, and calculated diastolic ocular perfusion pressure in patients with glaucoma., Invest. Ophthalmol. Vis. Sci., 2006, 47, 7, 2917-2923, doi: 10.1167/iovs.05-1253.