Condition category
Cancer
Date applied
18/07/2007
Date assigned
08/08/2007
Last edited
09/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 subject’s 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 measures

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

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 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

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 dell’Università 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

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16799034

Publication citations

  1. 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.

Additional files

Editorial Notes