Global DuoTrav® Study

Ocular Hypertension Clinical Trial

Official title:

Prospective, Randomized, Multi-Center Study to Evaluate the Efficacy and Tolerability of DuoTrav® in Patients Previously Uncontrolled on a Beta-blocker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003391
• Other study ID #: M-13-038
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2013
• Last updated: July 13, 2015
• Start date: December 2013
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics CommitteeAustralia: Human Research Ethics CommitteeMexico: Ethics CommitteeKorea: Institutional Review BoardRussia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate superior intraocular pressure (IOP) control with travoprost 0.004% / timolol 0.5% (DuoTrav®) compared to beta-blocker monotherapy in patients with open-angle glaucoma or ocular hypertension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a clinical diagnosis of either open angle glaucoma or ocular hypertension.

• Currently on beta-blocker monotherapy (for >30 days) and would benefit, in the opinion of the investigator, from further lOP reduction.

• Have a mean baseline lOP of >18 mmHg and <32 mmHg in at least one eye.

• Must be able to understand and sign an Informed Consent form.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Severe central visual field loss in either eye within the last year.

• Chronic, recurrent or severe inflammatory eye disease (e.g., sclerotic, uveitis, or herpes keratitis).

• Ocular trauma or surgery within the past 6 months.

• Ocular infection or ocular inflammation within the past 3 months.

• Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to 20/80 Snellen, 0.60 logMAR or 0.25 decimal).

• Any abnormality preventing reliable measurement of IOP.

• Other ocular pathology (including severe dry eye) that may, in the opinion of the investigator, preclude the administration of study medication.

• Condition that requires the use of any additional topical or systemic ocular hypotensive medication during the study.

• Hypersensitivity to prostaglandin analogues or any component of the study medications in the opinion of the investigator.

• Asthma, history of asthma, or severe chronic obstructive pulmonary disease.

• Condition that does not allow the patient to discontinue all glucocorticoids administered by any route safely.

• Therapy with another investigational agent within 30 days prior to Visit 1.

• Any other condition including severe illness which would make the patient, in the opinion of the investigator, unsuitable for the study.

• Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.

• Other protocol-specified exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• Beta-blocker monotherapy
Per subject's current prescribed therapy
• Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure (IOP) at 8AM	IOP (fluid pressure inside the eye) will be assessed using Goldmann applanation tonometry and is measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).	Week 4	No
Secondary	Mean change from baseline in IOP (8AM) at Week 4	IOP (fluid pressure inside the eye) will be assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement.	Baseline (Day 0), Week 4	No
Secondary	Percentage change from baseline in IOP (8AM) at Week 4	IOP (fluid pressure inside the eye) will be assessed using Goldmann applanation tonometry and is measured in mmHg. A negative change indicates an improvement.	Baseline (Day 0), Week 4	No