Assessing the efficacy and tolerability of changing to DuoTrav® as replacement therapy in patients previously on Bimatoprost/Timolol combination therapy

• Conditions: The study population must have been diagnosed with open angle glaucoma or ocular hypertension; MedDRA version: 14.1Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2011-000161-13-DE
• Lead Sponsor: Alcon Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-05
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Must be at least 18 years of age.
2. Must have a clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma in at least one eye.
3. Must be on a stable IOP lowering regimen of bimatoprost 0.03% / timolol 0.5% therapy (either administered concomitantly or in a fixed combination) within 4 weeks prior to the Screening Visit.
4. Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
5. Must have an IOP of between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye). In any eye not designated as a study eye, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
6. Must be willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
7. Must be able to follow instructions and be willing and able to attend all study visits.
8. Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
9. An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating subject, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
2. Any abnormality preventing reliable applanation tonometry in either eye.
3. Corneal dystrophies in either eye.
4. Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.
5. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
6. History of ocular herpes simplex.
7. Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
8. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator?s best judgment.
9. Progressive retinal or optic nerve disease from any cause apart from glaucoma.
10. Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
11. Bronchial asthma, history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
12. Sinus bradycardia, second- or third-degree atrioventricular block, overt cardiac failure, or cardiogenic shock that would preclude the safe administration of a topical beta-blocker.
13. History of severe allergic rhinitis.
14. Unwillingness to risk the possibility of darkened iris or eyelash changes.
15. A history of, or at risk for uveitis or cystoid macular edema (CME).
16. Any clinically significant, serious, or severe medical condition.
17. Women of childbearing potential not using reliable means of birth control for at least one month prior to the Screening/Baseline Visit. A reliable effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner.
18. Women who are pregnant or lactating.
19. A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
20. Participation in any other investigational study within 30 days prior to the Screening Visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess efficacy and tolerability of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior bimatoprost 0.03% /timolol 0.5% pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.;Secondary Objective: To evaluate ocular surface symptoms and ocular hyperemia after changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-free) for 12 weeks using the Ocular Surface Disease Index (OSDI) questionnaire, as well as a percentage of patients who reach a target IOP of = 18 mmHg.;Primary end point(s): Change in IOP at the final visit from prior bimatoprost 0.03%/timolol 0.5% fixed combination (Ganfort®) therapy i.e. from baseline;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in ocular surface disease index scores at final visit from baseline, change in hyperemia score at final visit from baseline, percentage of subjects who reach target IOP (</= 18 mmHg);Timepoint(s) of evaluation of this end point: 12 weeks