Trial Outcomes & Findings for Visual Performance Investigation of Two Toric Soft Contact Lenses (NCT NCT01858701)

Last Updated: 2014-10-22

Results Overview

Ocular coma is a type of optical aberration or a distortion in image formation occurring when a bundle of light rays enters an optical system (eye) that is not parallel to the optic axis. Ocular coma will be measured in micrometers using a Ladarwave aberrometer. A lower number indicates less coma/less image distortion. One eye (right eye) contributed to the mean.

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

Day 30

Results posted on

2014-10-22

Participant Flow

Participants were recruited from 1 study center located in Canada.

Of the 49 enrolled, 9 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (40).

Participant milestones

Participant milestones
Measure	AO for Astig / Biofinity Toric Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2.	Biofinity Toric / AO for Astig Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2.
Period 1, First 30 Days of Wear STARTED	20	20
Period 1, First 30 Days of Wear COMPLETED	20	19
Period 1, First 30 Days of Wear NOT COMPLETED	0	1
Washout Period, 1-13 Days STARTED	20	19
Washout Period, 1-13 Days COMPLETED	18	17
Washout Period, 1-13 Days NOT COMPLETED	2	2
Period 2, Second 30 Days of Wear STARTED	18	17
Period 2, Second 30 Days of Wear COMPLETED	18	16
Period 2, Second 30 Days of Wear NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	AO for Astig / Biofinity Toric Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2.	Biofinity Toric / AO for Astig Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2.
Period 1, First 30 Days of Wear Withdrawal by Subject	0	1
Washout Period, 1-13 Days Inclusion/Exclusion Criteria Not Met	1	0
Washout Period, 1-13 Days Withdrawal by Subject	1	2
Period 2, Second 30 Days of Wear Comfort	0	1

Baseline Characteristics

Visual Performance Investigation of Two Toric Soft Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=49 Participants Lotrafilcon B toric contact lenses and comfilcon A toric contact lenses worn during Period 1 and Period 2 in a crossover assignment.
Age, Continuous	28 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30

Population: This analysis population includes all participants who completed the study.

Outcome measures

Outcome measures
Measure	Air Optix for Astig n=34 Participants Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.	Biofinity Toric n=34 Participants Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
Mean Ocular Coma Score at 5mm Pupil at Day 30	0.16 micrometers Standard Deviation 0.09	0.24 micrometers Standard Deviation 0.11

Adverse Events

Air Optix for Astig

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Biofinity Toric

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

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