Efficacy of Changing to DUOTRAV® From Prior Therapy

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01327599
• Collaborator: (none)
• Enrollment: 60
• Arm: 1
• Duration (Months): 15

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Open-Angle Glaucoma; Ocular Hypertension; Pigment Dispersion Glaucoma	Drug: Travoprost 0.004%+Timolol 0.5% ophthalmic solution	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Aug 1, 2011
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DUOTRAV® Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks	Drug: Travoprost 0.004%+Timolol 0.5% ophthalmic solution; Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD); Other Names: DUOTRAV®

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline [Week 12]

   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.

Secondary Outcome Measures

1. Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline [Week 12]

   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.

2. Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline [Week 12]

   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.

3. Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline [Week 4, Week 12]

   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.

4. Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline [Week 4]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Severine Durier, Pharm.D, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01327599
• Other Study ID Numbers: RDG-10-272; 2011-000161-13
• First Posted: Apr 1, 2011
• Last Update Posted: Feb 10, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Alcon Research: Open-angle glaucoma; Ocular hypertension; Pigment dispersion glaucoma; Intraocular pressure
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Timolol; Travoprost; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 10 study centers in France and 3 study centers in Germany.
Pre-assignment Detail	This reporting group includes all enrolled participants.

Arm/Group Title	DUOTRAV®
Arm/Group Description	Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
Period Title: Overall Study
STARTED	60
COMPLETED	57
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	DUOTRAV®
Arm/Group Description	Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
Overall Participants	59
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.2 (9.8)
Sex: Female, Male (Count of Participants)
Female	38 64.4%
Male	21 35.6%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

All subjects using Ganfort at baseline who received study medication and attended Week 12 visit.

Arm/Group Title	DUOTRAV®
Arm/Group Description	Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
Measure Participants	55
Baseline (Day 1)	20.0 (1.0)
Change from baseline at Week 12	-3.8 (1.9)

2. Secondary Outcome

Title	Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.

Arm/Group Title	DUOTRAV®
Arm/Group Description	Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
Measure Participants	57
Baseline (Day 1)	14.9 (10.9)
Change from Baseline at Week 12	-3.6 (6.5)

3. Secondary Outcome

Title	Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline
Description	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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.

Arm/Group Title	DUOTRAV®
Arm/Group Description	Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
Measure Participants	57
Mean (Standard Deviation) [units on a scale]	-0.1 (0.7)

4. Secondary Outcome

Title	Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline
Description	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.
Time Frame	Week 4, Week 12

Outcome Measure Data

Analysis Population Description

ITT: All subjects using Ganfort at baseline who received study medication and had at least one on-therapy study visit, minus missing responses.

Arm/Group Title	DUOTRAV®
Arm/Group Description	Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
Measure Participants	57
Week 4	78.6 133.2%
Week 12	85.5 144.9%

5. Secondary Outcome

Title	Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline
Description	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.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

All subjects using Ganfort at baseline who received study medication and attended Week 4 visit.

Arm/Group Title	DUOTRAV®
Arm/Group Description	Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
Measure Participants	57
Baseline (Day 1)	20.1 (1.1)
Change from Baseline at Week 4	-3.8 (2.1)

Adverse Events

Time Frame	Adverse events were collected for the duration of the study (1 year, 3 months). An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship.
Adverse Event Reporting Description	Adverse events were collected spontaneously from the subjects and systematically by inquiry and review of protocol-specific ocular or systemic parameters evaluated during the study. This reporting group includes all participants who received study medication.
Arm/Group Title	DUOTRAV®
Arm/Group Description	Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
All Cause Mortality
	DUOTRAV®
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	DUOTRAV®
	Affected / at Risk (%)	# Events
Total	0/60 (0%)
Other (Not Including Serious) Adverse Events
	DUOTRAV®
	Affected / at Risk (%)	# Events
Total	0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

France: All results obtained during this study are the property of the Sponsor. All information given to the investigators must remain confidential and cannot be used outside the framework of this study. Germany: Investigators can publish results 12 months after the Sponsor's final evaluation of the data. The Sponsor is entitled to request a delay of such publication due to business or operational reasons.