Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures

• Sponsor: University of Milan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02154217
• Collaborator: (none)
• Enrollment: 200
• Locations: 9
• Arms: 2
• Patients Per Site: 22.2

Study Details

Study Description

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].

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Bimatoprost; Drug: Latanoprost/Timolol	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures
• Actual Primary Completion Date: Dec 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bimatoprost once daily	Drug: Bimatoprost
Experimental: Latanoprost/Timolol once daily	Drug: Latanoprost/Timolol

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

11. Any drug known to affect IOP.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitaets-augenklinik	Dresden		Germany
2	Universitaets-augenklinik	Magdeburg		Germany
3	Department of Ophthalmology, University of Thessaly, University Hos- pital of Larissa	Larissa		Greece
4	II Department of Ophthalmology, Aristotle University of Thessaloniki	Thessaloniki		Greece
5	A.O. San Paolo	Milan	Lombardy	Italy	20142
6	Clinica Oculistica, Dipartimento di Oftalmologia-Otorinolaringoiatria, Università di Bari	Bari		Italy
7	Clinica Oculistica, Università degli studi di Roma, Tor Vergata	Rome		Italy
8	Universitäts-Augenklinik, Inselspital, University of Bern	Bern		Switzerland
9	Moorfields Eye Hospital,	London		United Kingdom

Sponsors and Collaborators

• University of Milan

Investigators

• Principal Investigator: Luca Rossetti, MD, A.O. San Paolo Hospital Milan Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Paolo Fogagnolo, MD, University of Milan
• ClinicalTrials.gov Identifier: NCT02154217
• Other Study ID Numbers: LR-BLT
• First Posted: Jun 3, 2014
• Last Update Posted: Jun 3, 2014
• Last Verified: May 1, 2014

• Additional relevant MeSH terms: Glaucoma; Timolol; Bimatoprost; Latanoprost

Study Results

No Results Posted as of Jun 3, 2014