Trial Outcomes & Findings for Efficacy and Safety of Travoprost 0.004% Versus Tafluprost 0.0015% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension (NCT NCT00966940)

Results Overview

Intraocular pressure was measured by Goldmann applanation tonometry.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

51 participants

Primary outcome timeframe

6 weeks

Results posted on

2012-06-20

Participant Flow

Patients were recruited from four private practices located in Germany.

Participant milestones

Participant milestones
Measure	Travoprost-to-tafluprost Travoprost, then tafluprost	Tafluprost-to-travoprost Tafluprost, then travoprost
Period 1, First 6 Weeks STARTED	28	23
Period 1, First 6 Weeks COMPLETED	25	23
Period 1, First 6 Weeks NOT COMPLETED	3	0
Period 2, Second 6 Weeks STARTED	25	23
Period 2, Second 6 Weeks COMPLETED	25	23
Period 2, Second 6 Weeks NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Travoprost-to-tafluprost Travoprost, then tafluprost	Tafluprost-to-travoprost Tafluprost, then travoprost
Period 1, First 6 Weeks Withdrawal by Subject	2	0
Period 1, First 6 Weeks Protocol Violation	1	0

Baseline Characteristics

Efficacy and Safety of Travoprost 0.004% Versus Tafluprost 0.0015% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Travoprost-to-tafluprost n=28 Participants Travoprost, then tafluprost	Tafluprost-to-travoprost n=23 Participants Tafluprost, then travoprost	Total n=51 Participants Total of all reporting groups
Age Continuous	69.1 years STANDARD_DEVIATION 7.8 • n=99 Participants	68.5 years STANDARD_DEVIATION 10.5 • n=107 Participants	68.8 years STANDARD_DEVIATION 9.0 • n=206 Participants
Sex: Female, Male Female	16 Participants n=99 Participants	15 Participants n=107 Participants	31 Participants n=206 Participants
Sex: Female, Male Male	12 Participants n=99 Participants	8 Participants n=107 Participants	20 Participants n=206 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Intraocular pressure was measured by Goldmann applanation tonometry.

Outcome measures

Outcome measures
Measure	Travoprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	Tafluprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Mean Intraocular Pressure (IOP) at 8:00 PM	17.1 mm Hg Standard Deviation 3.17	17.7 mm Hg Standard Deviation 3.23

SECONDARY outcome

Timeframe: 6 weeks

Population: This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Intraocular pressure was measured by Goldmann applanation tonometry.

Outcome measures

Outcome measures
Measure	Travoprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	Tafluprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Mean Intraocular Pressure (IOP) at 8:00 AM	17.0 mm Hg Standard Deviation 2.36	17.5 mm Hg Standard Deviation 2.20

SECONDARY outcome

Timeframe: 6 weeks

Population: This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Intraocular pressure was measured by Goldmann applanation tonometry.

Outcome measures

Outcome measures
Measure	Travoprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	Tafluprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Mean Intraocular Pressure (IOP) at 10:00 AM	16.7 mm Hg Standard Deviation 2.39	17.3 mm Hg Standard Deviation 2.50

SECONDARY outcome

Timeframe: 6 weeks

Population: This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Intraocular pressure was measured by Goldmann applanation tonometry.

Outcome measures

Outcome measures
Measure	Travoprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	Tafluprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Mean Intraocular Pressure (IOP) at 12:00 PM	16.7 mm Hg Standard Deviation 2.47	17.2 mm Hg Standard Deviation 2.46

SECONDARY outcome

Timeframe: 6 weeks

Population: This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Intraocular pressure was measured by Goldmann applanation tonometry.

Outcome measures

Outcome measures
Measure	Travoprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	Tafluprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Mean Intraocular Pressure (IOP) at 2:00 PM	16.9 mm Hg Standard Deviation 2.69	17.3 mm Hg Standard Deviation 2.77

SECONDARY outcome

Timeframe: 6 weeks

Population: This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Intraocular pressure was measured by Goldmann applanation tonometry.

Outcome measures

Outcome measures
Measure	Travoprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	Tafluprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Mean Intraocular Pressure (IOP) at 4:00 PM	17.1 mm Hg Standard Deviation 2.85	17.6 mm Hg Standard Deviation 2.80

SECONDARY outcome

Timeframe: 6 weeks

Population: This reporting group includes all patients randomized to both periods of the study and exposed to both study drugs.

Intraocular pressure was measured by Goldmann applanation tonometry.

Outcome measures

Outcome measures
Measure	Travoprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically	Tafluprost n=48 Participants One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
Mean Intraocular Pressure (IOP) at 6:00 PM	16.9 mm Hg Standard Deviation 3.12	17.6 mm Hg Standard Deviation 3.13

Adverse Events

Travoprost

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tafluprost

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

Director of Medical Affairs

Alcon Research, Ltd.

Phone: 1-800-862-5266

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60