Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination) From Prior Therapy

Glaucoma Clinical Trial

Official title:

Assessing the Efficacy and Tolerability of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Prior Prostaglandin Fixed Combination

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01514721
• Other study ID #: RDG-11-171
• Status: Terminated
• Phase: Phase 4
• First received: January 18, 2012
• Last updated: December 2, 2014
• Start date: June 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess efficacy and tolerability of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom® or Ganfort® fixed combination pharmacotherapy in patients with open-angle glaucoma or ocular hypertension with uncontrolled intraocular pressure (IOP).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of ocular hypertension, open-angle glaucoma, or pigment dispersion glaucoma in both eyes.

• On a stable IOP-lowering regimen of prostaglandin fixed combination (either Xalacom or Ganfort) within 4 weeks prior to the Screening Visit.

• IOP between 19 and 35 mmHg at any time of day in at least 1 eye.

• Best corrected visual acuity (BCVA) of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.

• 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.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known medical history of allergy, hypersensitivity, or poor tolerance to any component of DuoTrav® deemed clinically significant in the opinion of the Principal Investigator.

• Corneal dystrophies in either eye.

• Risk of visual field or VA worsening as a consequence of participation in the study, in the investigator's best judgment.

• Any disease or condition that would preclude the safe administration of a topical beta-blocker, present a special risk to the subject, or interfere with optimal participation in the study.

• Women who are pregnant or lactating.

• Participation in any other investigational study within 30 days prior to the Screening Visit.

• Other protocol-defined exclusion criteria may apply.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Travoprost/Timolol Maleate BAK-Free Fixed Combination
Commercially marketed Travoprost/Timolol BAK-free ophthalmic solution indicated for the treatment of patients with open angle glaucoma (OAG) or ocular hypertension (OH).

Locations

Country	Name	City	State
Brazil	Alcon Investigational Site	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intra-ocular pressure (IOP) at final visit from prior therapy (i.e., from baseline)	Goldmann applanation tonometry will be performed at the baseline visit and the 12-week visit to record IOP. Change in IOP will be calculated. IOP will be measured in mmHg.	12 weeks	No
Secondary	Percentage of patients who reach target IOP (=18mmHg)	Goldmann applanation tonometry will be performed at the 12-week visit to record IOP. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP =18mmHg to the overall study population.	12 weeks	No
Secondary	Change in Ocular Surface Disease Index (OSDI) score at final visit from baseline	An OSDI questionnaire will be completed by the subject at the baseline visit and at the 12-week visit. For each visit, an overall OSDI score will be calculated using individual item responses, and the change in OSDI score from baseline will be calculated.	12 weeks	No
Secondary	Change in ocular hyperemia score at final visit from baseline	Ocular hyperemia will be assessed by qualified personnel at the baseline visit and again at the 12-week visit, and change from baseline will be calculated.	12 weeks	No