Glaucoma
Conditions
Brief summary
This is a data revision with a focus on 24 hour perfusion pressures of data from a previous randomized, double masked, multicenter clinical trial. The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a nonfixed combination of latanoprost and timolol. The main findings of the original trial had been published on Ophthalmology \[2007;114: 2244-2251\].
Interventions
DRUGBimatoprost
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients diagnosed as having POAG (primary open-angle glaucoma) or ocular hypertension and 18 years or older who fulfilled the eligibility requirements detailed below and signed an informed consent at the screening visit were included. Two different groups of patients were potentially eligible: 1. Those patients who were controlled (IOP\< 21 mmHg) on the nonfixed combination of latanoprost and timolol (twice daily or once daily morning administration) for at least 3 months prior to the baseline visit. 2. Patients on monotherapy either with latanoprost or timolol who were eligible for dual therapy being not satisfactorily controlled (IOP \< 21 mmHg, or, as judged by the physician, target IOP was not reached). Pseudoexfoliation glaucomas and patients with diabetes were not excluded.
Exclusion criteria
All patients in whom beta-blockers were contraindicated were excluded. Ocular Condition. 1. Closed/barely open anterior chamber angles (ACAs) or history of acute angle closure. The ACA was viewed by means of the Goldmann 1-mirror lens. Shaffer grading was used, and grades II, III, and IV were included. Grades 0 and I were excluded. 2. Ocular surgery or argon laser trabeculoplasty within the last 3 months. 3. Ocular inflammation/infection occurring within 3 months before the pretrial visit. 4. Neovascular glaucomas. 5. Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions. 6. Other abnormal ocular condition or symptom preventing the patient from entering the trial, according to the investigator's judgement. 7. Patients on either bimatoprost or the LTFC. 8. Patients who had undergone refractive surgery. General 9. Inability to adhere to treatment/visit plan. 10. Participation in any other clinical trial (i.e., requiring in- formed consent) within 1 month before the prestudy visit. 11. Pregnancy, nursing, or, if applicable, nonuse of adequate contraception. 12\. Any drug known to affect IOP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean diastolic and systolic perfusion pressures | Baseline - Week 2 - Week 6 - Week 12 | The Primary outcome was the difference in mean diastolic and systolic perfusion pressures after bimatoprost and the LTFC |
Countries
Germany, Greece, Italy, Switzerland, United Kingdom
Outcome results
None listed