Trial Outcomes & Findings for Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution (NCT NCT01809197)

Last Updated: 2014-07-22

Results Overview

Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.

Recruitment status

COMPLETED

Study phase

Target enrollment

387 participants

Primary outcome timeframe

Day 30; after 4 hours of lens wear

Results posted on

2014-07-22

Participant Flow

Subjects were recruited from 22 study sites located in the US.

Of the 387 enrolled, 15 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (372).

Participant milestones

Participant milestones
Measure	Air Optix/OFPM Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system	Acuvue Oasys/Habitual MPS Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
Overall Study STARTED	187	185
Overall Study COMPLETED	177	177
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Air Optix/OFPM Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system	Acuvue Oasys/Habitual MPS Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
Overall Study Lost to Follow-up	4	2
Overall Study Adverse Event	2	3
Overall Study Failed slit lamp exam	1	0
Overall Study Non-Compliance	1	1
Overall Study Decision Unrelated to an Adverse Event	1	0
Overall Study Withdrawal by Subject	1	1
Overall Study Product not available	0	1

Baseline Characteristics

Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Air Optix/OFPM n=187 Participants Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system	Acuvue Oasys/Habitual MPS n=184 Participants Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system	Total n=371 Participants Total of all reporting groups
Age, Continuous	32.4 years STANDARD_DEVIATION 10.12 • n=5 Participants	35.0 years STANDARD_DEVIATION 11.14 • n=7 Participants	33.7 years STANDARD_DEVIATION 10.70 • n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants	142 Participants n=7 Participants	283 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	42 Participants n=7 Participants	88 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30; after 4 hours of lens wear

Population: This analysis population includes all subjects who were randomized and received study regimen (test or control) with a Day 30 response to this Likert item.

Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.

Outcome measures

Outcome measures
Measure	Air Optix/OFPM n=178 Participants Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system	Acuvue Oasys/Habitual MPS n=177 Participants Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"	4.2 units on a scale Standard Deviation 0.90	4.4 units on a scale Standard Deviation 0.66

Adverse Events

Air Optix/OFPM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acuvue Oasys/Habitual MPS

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

Jessie Lemp, GMA Brand Lead - Vision Care

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