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ONG-TERM 24-HOUR INTRAOCULAR PRESSURE CONTROL AND PROGRESSION RATE OBTAINED WITH THE ASSOCIATION OF COMBIGAN IN THE MORNING AND GANFORT IN THE EVENING COMPARED WITH LATANOPROST IN HIGH RISK OPEN-ANGLE GLAUCOMA.

Phase 1
Conditions
Patients with glaucoma open angle or glaucoma exfoliative with high risknewly diagnosed and untreated.
Therapeutic area: Diseases [C] - Eye Diseases [C11]
Registration Number
EUCTR2013-001634-17-IT
Lead Sponsor
AZIENDA OSPEDALIERA S. PAOLO
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
60
Inclusion Criteria

-Newly diagnosed untreated patients;
-Willingness to comply with the investigator’s and protocol’s instructions;
->21 years of age;
-IOP equal to 27 mm Hg or more, at 10:00 am;
-Early to moderate POAG or XFG, exhibiting a visual field damage between –5 dB and -12 dB;
-High risk profile for progression.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- < 21 years of age;
- On any medication that can interfere with study drugs;
- Any comorbidity that could interfere with disease progress or VF reading;
- Ocular surgery within last 6 months;
- Pregnancy;
- Allergic or intolerable to any components in study drugs;
- Participating in any other study;
- Inability to give informed consent;
-Reactive airway disease, second or third degree heart block, poorly compensated congestive heart failure or concomitant use of systemic beta-blockers.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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