Trial Outcomes & Findings for DAILIES TOTAL1® Lens Centration in a Japanese Population (NCT NCT02252133)

Results Overview

Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

53 participants

Primary outcome timeframe

Day 7, each product

Results posted on

2016-01-29

Participant Flow

Subjects were recruited from 3 study centers located in Japan.

Of the 53 enrolled, 6 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (47).

Participant milestones

Participant milestones
Measure	DT1, Then 1DAVTE Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.	1DAVTE, Then DT1 Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
Period 1 STARTED	23	24
Period 1 COMPLETED	23	24
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	23	24
Period 2 COMPLETED	23	24
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DAILIES TOTAL1® Lens Centration in a Japanese Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=47 Participants DAILIES TOTAL1® and 1-Day Acuvue® TruEye® contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Age, Continuous	37.0 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7, each product

Population: This analysis population includes all subjects who used the study lenses and who met all inclusion criteria and did not meet any exclusion criteria.

Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.

Outcome measures

Outcome measures
Measure	Dailies Total 1 n=42 Participants Delefilcon A contact lenses during Period 1 or Period 2 for 7 days.	1DAVTE n=45 Participants Narafilcon A contact lenses worn during Period 1 or Period 2 for 7 days.
Success Rate of Lens Centration After 7 ± 2 Days of Wear	100.0 percentage of subjects	86.7 percentage of subjects

Adverse Events

Dailies Total 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1DAVTE

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

Senior Manager, Clinical Development, Japan

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER