Trial Outcomes & Findings for DW Evaluation of Lotrafilcon B Lenses in a Modified Design (NCT NCT02157909)

Results Overview

With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of "no re-fit," an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

134 participants

Primary outcome timeframe

Dispense (Day 0), Week 1

Results posted on

2015-08-11

Participant Flow

Subjects were recruited from 5 study centers located in the US.

Of the 134 enrolled, 2 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (132).

Participant milestones

Participant milestones
Measure	AOA Modified Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days	AOA Sphere Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
Overall Study STARTED	66	66
Overall Study COMPLETED	66	66
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DW Evaluation of Lotrafilcon B Lenses in a Modified Design

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AOA Modified n=66 Participants Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days	AOA Sphere n=66 Participants Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days	Total n=132 Participants Total of all reporting groups
Age, Continuous	29.9 years STANDARD_DEVIATION 9.5 • n=5 Participants	31.3 years STANDARD_DEVIATION 9.8 • n=7 Participants	30.6 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	50 Participants n=7 Participants	95 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Dispense (Day 0), Week 1

Population: This analysis population includes all randomized and treated subjects.

With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of "no re-fit," an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.

Outcome measures

Outcome measures
Measure	AOA Modified n=66 Participants Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days	AOA Sphere n=66 Participants Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes Dispense (Day 0)	100.0 percentage of subjects	100.0 percentage of subjects
Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes Week 1	100.0 percentage of subjects	100.0 percentage of subjects

Adverse Events

Pre-treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AOA Modified

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AOA Sphere

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

Head Clinical Development, Vision Care, GCRA

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