Trial Outcomes & Findings for Efficacy of Changing to DUOTRAV® From Prior Therapy (NCT NCT01327599)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

Week 12

Results posted on

2014-02-10

Participant Flow

Participants were recruited from 10 study centers in France and 3 study centers in Germany.

This reporting group includes all enrolled participants.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	60
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Adverse Event	1
Overall Study Could Not Attend Visit	1
Overall Study Withdrawal of Consent	1

Baseline Characteristics

Efficacy of Changing to DUOTRAV® From Prior Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DUOTRAV® n=59 Participants 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
Age, Continuous	73.2 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

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

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.

Outcome measures

Outcome measures
Measure	DUOTRAV® n=55 Participants 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
Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline Baseline (Day 1)	20.0 millimeters mercury (mmHg) Standard Deviation 1.0
Mean Change From Baseline in IOP at Week 12 in Subjects Using Ganfort® at Baseline Change from baseline at Week 12	-3.8 millimeters mercury (mmHg) Standard Deviation 1.9

SECONDARY outcome

Timeframe: Week 12

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

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.

Outcome measures

Outcome measures
Measure	DUOTRAV® n=57 Participants 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
Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline Baseline (Day 1)	14.9 Units on a scale Standard Deviation 10.9
Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Week 12 in Subjects Using Ganfort® at Baseline Change from Baseline at Week 12	-3.6 Units on a scale Standard Deviation 6.5

SECONDARY outcome

Timeframe: Week 12

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

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.

Outcome measures

Outcome measures
Measure	DUOTRAV® n=57 Participants 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
Mean Change From Baseline in Ocular Hyperemia Score at Week 12 in Subjects Using Ganfort® at Baseline	-0.1 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Week 4, Week 12

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

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.

Outcome measures

Outcome measures
Measure	DUOTRAV® n=57 Participants 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
Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline Week 4	78.6 percentage of participants
Percentage of Subjects Who Reach Target IOP of ≤ 18 mmHg in Subjects Using Ganfort® at Baseline Week 12	85.5 percentage of participants

SECONDARY outcome

Timeframe: Week 4

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

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.

Outcome measures

Outcome measures
Measure	DUOTRAV® n=57 Participants 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
Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline Baseline (Day 1)	20.1 millimeters mercury (mmHg) Standard Deviation 1.1
Mean Change From Baseline in IOP at Week 4 in Subjects Using Ganfort® at Baseline Change from Baseline at Week 4	-3.8 millimeters mercury (mmHg) Standard Deviation 2.1

Adverse Events

DUOTRAV®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Doug Hubatsch, Therapeutic Unit Head, Global Medical Affairs

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER