Trial Outcomes & Findings for Adherence Assessment With Travalert Dosing Aid (NCT NCT00508469)

Results Overview

Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

102 participants

Primary outcome timeframe

6 months

Results posted on

2012-07-12

Participant Flow

Patients were recruited from 5 hospitals in Spain.

Baseline characteristics are presented for the per-protocol population.

Participant milestones

Participant milestones
Measure	Travalert With Travoprost/Timolol Fixed Combination One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.	Travalert With Travoprost and Timolol One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
Overall Study STARTED	52	50
Overall Study COMPLETED	35	40
Overall Study NOT COMPLETED	17	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adherence Assessment With Travalert Dosing Aid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Travalert With Travoprost/Timolol Fixed Combination n=43 Participants One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.	Travalert With Travoprost and Timolol n=42 Participants One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.	Total n=85 Participants Total of all reporting groups
Age Continuous	63.8 years STANDARD_DEVIATION 11.1 • n=5 Participants	68.6 years STANDARD_DEVIATION 11.8 • n=7 Participants	66.2 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Per protocol

Patients were considered adherent if a minimum of 80% of their instillations were administered ±2 hours of the scheduled time.

Outcome measures

Outcome measures
Measure	Travalert With Travoprost/Timolol Fixed Combination n=43 Participants One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.	Travalert With Travoprost and Timolol n=42 Participants One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
Adherence	63 percentage of adherent patients	43 percentage of adherent patients

Adverse Events

Travalert With Travoprost/Timolol Fixed Combination

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Travalert With Travoprost and Timolol

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Travalert With Travoprost/Timolol Fixed Combination n=52 participants at risk One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.	Travalert With Travoprost and Timolol n=50 participants at risk One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
Cardiac disorders Heart Failure	1.9% 1/52 • Number of events 1 • Adverse events were collected for the duration of the study: 2 years, 3 months. The safety population includes all enrolled patients.	0.00% 0/50 • Adverse events were collected for the duration of the study: 2 years, 3 months. The safety population includes all enrolled patients.
Cardiac disorders Brachycardia	0.00% 0/52 • Adverse events were collected for the duration of the study: 2 years, 3 months. The safety population includes all enrolled patients.	2.0% 1/50 • Number of events 1 • Adverse events were collected for the duration of the study: 2 years, 3 months. The safety population includes all enrolled patients.

Other adverse events

Adverse event data not reported

Additional Information

Severine Durier, PharmD

Alcon France

Phone: +33 1 47 10 48 43

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER