Success of Transitioning Uncontrolled Glaucoma Patients From Prior Mono or Adjunctive Therapy to DuoTrav

Glaucoma Clinical Trial

Official title:

Safety and Efficacy of Switching to the Travoprost/Timolol Maleate Fixed Combination (DUOTRAV®) From Prior Mono or Two-Drug Therapy in Germany

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519753
• Other study ID #: CMS-06-12
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2007
• Last updated: November 17, 2016
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: January 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of transitioning uncontrolled glaucoma patients to DuoTrav from other mono or adjunctive therapies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Age related.

• Other protocol-defined exclusion criteria may apply.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav)
One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks

Locations

Country	Name	City	State
Germany	Mainz	Mainz

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pfeiffer N, Scherzer ML, Maier H, Schoelzel S, Jasek MC, Stewart JA, Stewart WC. Safety and efficacy of changing to the travoprost/timolol maleate fixed combination (DuoTrav) from prior mono- or adjunctive therapy. Clin Ophthalmol. 2010 May 14;4:459-66. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intraocular pressure at 12 weeks from travoprost prior therapy (baseline)		Baseline and 12 weeks	No
Secondary	Change in intraocular pressure at 12 weeks from other prior therapies (baseline)		12 weeks	No