Trial Outcomes & Findings for Efficacy Study of Travoprost APS Versus TRAVATAN (NCT NCT00848536)

Results Overview

For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

371 participants

Primary outcome timeframe

3 months (measured at 9:00 am)

Results posted on

2012-04-06

Participant Flow

Patients were recruited from 30 study centers: 8 in the US, 6 in Mexico, 2 in Brazil, 4 in India, 2 in Australia, 2 in New Zealand, 2 in Latvia, and a single site in each: Taiwan, France, Belgium, and Italy.

Participant milestones

Participant milestones
Measure	TRAVATAN APS One drop once daily in the evening for 3 months	TRAVATAN One drop once daily in the evening for 3 months
Overall Study STARTED	185	186
Overall Study COMPLETED	181	179
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	TRAVATAN APS One drop once daily in the evening for 3 months	TRAVATAN One drop once daily in the evening for 3 months
Overall Study Adverse Event	2	2
Overall Study Withdrawal by Subject	0	1
Overall Study Protocol Violation	0	1
Overall Study Noncompliance	1	0
Overall Study Inadequate Control of IOP	1	1
Overall Study Patient Moved	0	2

Baseline Characteristics

Efficacy Study of Travoprost APS Versus TRAVATAN

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TRAVATAN APS n=185 Participants One drop once daily in the evening for 3 months	TRAVATAN n=186 Participants One drop once daily in the evening for 3 months	Total n=371 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	94 Participants n=5 Participants	109 Participants n=7 Participants	203 Participants n=5 Participants
Age, Categorical >=65 years	91 Participants n=5 Participants	77 Participants n=7 Participants	168 Participants n=5 Participants
Sex: Female, Male Female	112 Participants n=5 Participants	115 Participants n=7 Participants	227 Participants n=5 Participants
Sex: Female, Male Male	73 Participants n=5 Participants	71 Participants n=7 Participants	144 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months (measured at 9:00 am)

Population: Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.

For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis

Outcome measures

Outcome measures
Measure	TRAVATAN APS n=172 Participants One drop once daily in the evening for 3 months	TRAVATAN n=172 Participants One drop once daily in the evening for 3 months
Mean Intraocular Pressure at 9:00 am	17.9 mmHg Standard Error 0.25	18.1 mmHg Standard Error 0.25

PRIMARY outcome

Timeframe: 3 months (measured at 11:00 am)

Population: Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.

For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis

Outcome measures

Outcome measures
Measure	TRAVATAN APS n=171 Participants One drop once daily in the evening for 3 months	TRAVATAN n=171 Participants One drop once daily in the evening for 3 months
Mean Intraocular Pressure at 11:00 am	17.4 mmHg Standard Error 0.25	17.5 mmHg Standard Error 0.25

PRIMARY outcome

Timeframe: 3 months (measured at 4:00 pm)

Population: Per-Protocol. Patients who received study medication, satisfied pre-randomization criteria and satisfied protocol criteria at the specific time point were considered evaluable for PP analysis.

For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis

Outcome measures

Outcome measures
Measure	TRAVATAN APS n=171 Participants One drop once daily in the evening for 3 months	TRAVATAN n=171 Participants One drop once daily in the evening for 3 months
Mean Intraocular Pressure at 4:00 pm	16.9 mmHg Standard Error 0.25	17.1 mmHg Standard Error 0.25

Adverse Events

TRAVATAN APS

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

TRAVATAN

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TRAVATAN APS n=185 participants at risk One drop once daily in the evening for 3 months	TRAVATAN n=186 participants at risk One drop once daily in the evening for 3 months
Gastrointestinal disorders Abdominal mass	0.54% 1/185 • Number of events 1 • 3 Months	0.00% 0/186 • 3 Months
General disorders Chest pain	0.00% 0/185 • 3 Months	0.54% 1/186 • Number of events 1 • 3 Months
Infections and infestations Pneumonia	0.00% 0/185 • 3 Months	0.54% 1/186 • Number of events 1 • 3 Months

Other adverse events

Other adverse events
Measure	TRAVATAN APS n=185 participants at risk One drop once daily in the evening for 3 months	TRAVATAN n=186 participants at risk One drop once daily in the evening for 3 months
Eye disorders Ocular hyperaemia	11.4% 21/185 • Number of events 22 • 3 Months	10.2% 19/186 • Number of events 22 • 3 Months
Eye disorders Eye irritation	3.8% 7/185 • Number of events 8 • 3 Months	5.9% 11/186 • Number of events 12 • 3 Months
Eye disorders Conjunctival hyperaemia	4.3% 8/185 • Number of events 9 • 3 Months	5.4% 10/186 • Number of events 10 • 3 Months

Additional Information

Director Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937 or 817.568.6725

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60