Clinical trial NCT02154217: Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures
Official title: Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[2007;114: 2244-2251\].


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in mean diastolic and systolic perfusion pressures
timeFrame: Baseline - Week 2 - Week 6 - Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitaets-augenklinik
city: Magdeburg
country: Germany
facility: Universitaets-augenklinik
city: Larissa
country: Greece
facility: Department of Ophthalmology, University of Thessaly, University Hos- pital of Larissa
city: Thessaloniki
country: Greece
facility: II Department of Ophthalmology, Aristotle University of Thessaloniki
city: Milan
country: Italy
facility: A.O. San Paolo
state: Lombardy
city: Bari
country: Italy
facility: Clinica Oculistica, Dipartimento di Oftalmologia-Otorinolaringoiatria, Università di Bari
city: Rome
country: Italy
facility: Clinica Oculistica, Università degli studi di Roma, Tor Vergata
city: Bern
country: Switzerland
facility: Universitäts-Augenklinik, Inselspital, University of Bern
city: London
country: United Kingdom
facility: Moorfields Eye Hospital,
Study officials:
affiliation: A.O. San Paolo Hospital Milan Italy
name: Luca Rossetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rossetti L, Karabatsas CH, Topouzis F, Vetrugno M, Centofanti M, Boehm A, Viswanathan A, Vorwerk C, Goldblum D. Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on circadian intraocular pressure. Ophthalmology. 2007 Dec;114(12):2244-51. doi: 10.1016/j.ophtha.2007.01.025. Epub 2007 Apr 25.
citation: Rossetti L, Sacchi M, Karabatsas CH, Topouzis F, Vetrugno M, Centofanti M, Boehm A, Vorwerk C, Goldblum D, Fogagnolo P. Comparison of the effects of bimatoprost and a fixed combination of latanoprost and timolol on 24-hour blood and ocular perfusion pressures: the results of a randomized trial. BMC Ophthalmol. 2015 Jan 22;15:7. doi: 10.1186/1471-2415-15-7.