Efficacy of Changing to DUOTRAV® From Prior Therapy

Ocular Hypertension 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 Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01327599
• Other study ID #: RDG-10-272
• Secondary ID: 2011-000161-13
• Status: Completed
• Phase: Phase 4
• First received: March 30, 2011
• Last updated: January 13, 2014
• Start date: August 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma in at least one eye.

• 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.

• IOP considered to be safe (in the opinion of the investigator), in both eyes, to assure clinical stability of vision and the optic nerve throughout the study period.

• IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study 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.

• Able to follow instructions and willing and able to attend all study visits.

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

• Sign informed consent.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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.

• Corneal dystrophies in either eye.

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

• Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.

• History of severe allergic rhinitis.

• 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.

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

Intervention

Drug:
• Travoprost 0.004%+Timolol 0.5% ophthalmic solution
Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline	IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.	Week 12	No
Secondary	Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline	The OSDI is a 12-item quality of life questionnaire designed to assess ocular surface symptoms, their severity, and their impact on the subject's ability to function. Each item was scored by the subject on a 0-4 Likert-type scale (0=None, 4=All of the Time), with a resultant overall score of 0-100 (0=no disability, 100=complete disability). A negative number change from baseline represents a perceived improvement in ocular health.	Week 12	No
Secondary	Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline	Ocular hyperemia (visible eye redness) was assessed during slit lamp examination and graded on a 5-point scale (0=none, 4=severe). A positive number change from baseline indicates an increase in ocular redness. One eye was chosen as the study eye, and only the study eye was used for analysis.	Week 12	No
Secondary	Percentage of Subjects Who Reach Target IOP of = 18 mmHg in Subjects Using Ganfort® at Baseline	IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. An increase in intraocular pressure may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.	Week 4, Week 12	No
Secondary	Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline	IOP (fluid pressure in the eye) was measured with Goldmann applanation tonometry. A positive number change from baseline indicates an increase in intraocular pressure, which may be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only the study eye was used for analysis.	Week 4	No