Trial Outcomes & Findings for Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers (NCT NCT01244529)

Results Overview

Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

after 15 minutes of contact lens wear

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	All Arms, All Interventions All subjects wore all intervention throughout the course of the study.
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=41 Participants All subjects who where enrolled wore all intervention lenses throughout the course of the study. The specific lenses used include the following: senofilcon A (control) soft contact lens with 8.8 base; senofilcon A (control) soft contact lens with 8.4 base curve; galyfilcon A (control) soft contact lens with 8.7 base curve; galyfilcon A (control) soft contact lens with 8.3 base curve; galyfilcon A Plus (test) soft contact lens with 8.7 base curve; galyfilcon A Plus (test) soft contact lens with 8.3 base curve.
Age, Continuous	34.0 years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United Kingdom	41 participants n=5 Participants

PRIMARY outcome

Timeframe: after 15 minutes of contact lens wear

Population: Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.

Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.

Outcome measures

Outcome measures
Measure	Galyfilcon A Plus (Test) n=82 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon A (Control) n=82 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Senofilcon A n=82 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon AP 8.7 BC All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon A 8.7 BC All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Senofilcon A 8.8 BC All subjects wore each of the lenses at a point in the study as this was a contralateral study.
Lens Centration Acceptance Acceptable centration	74 eyes	62 eyes	69 eyes	—	—	—
Lens Centration Acceptance Unacceptable centration	8 eyes	20 eyes	13 eyes	—	—	—

PRIMARY outcome

Timeframe: after 15 minutes of contact lens wear

Population: Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.

Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.

Outcome measures

Outcome measures
Measure	Galyfilcon A Plus (Test) n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon A (Control) n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Senofilcon A n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon AP 8.7 BC n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon A 8.7 BC n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Senofilcon A 8.8 BC n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.
Primary Gaze Lens Movement Acceptable movement	93 percentage of eyes	93 percentage of eyes	100 percentage of eyes	93 percentage of eyes	90 percentage of eyes	98 percentage of eyes
Primary Gaze Lens Movement Unacceptable movement	7 percentage of eyes	7 percentage of eyes	0 percentage of eyes	7 percentage of eyes	10 percentage of eyes	2 percentage of eyes

PRIMARY outcome

Timeframe: after 15 minutes of contact lens wear

Population: Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.

Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.

Outcome measures

Outcome measures
Measure	Galyfilcon A Plus (Test) n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon A (Control) n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Senofilcon A n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon AP 8.7 BC n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon A 8.7 BC n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Senofilcon A 8.8 BC n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.
Fit Acceptability Acceptable Fit	90 percentage of eyes	90 percentage of eyes	95 percentage of eyes	83 percentage of eyes	71 percentage of eyes	80 percentage of eyes
Fit Acceptability Unacceptable Fit	10 percentage of eyes	10 percentage of eyes	5 percentage of eyes	17 percentage of eyes	29 percentage of eyes	20 percentage of eyes

SECONDARY outcome

Timeframe: after 15 minutes of contact lens wear

Population: Analysis was on those completed subjects who were enrolled, randomized, and assigned to a study arm.

The lens power fit of test lenses will be compared to control lenses to determine if the power matches. Percent of eyes with exact power fit will be evaluated.

Outcome measures

Outcome measures
Measure	Galyfilcon A Plus (Test) n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon A (Control) n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Senofilcon A n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon AP 8.7 BC n=41 eyes All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Galyfilcon A 8.7 BC All subjects wore each of the lenses at a point in the study as this was a contralateral study.	Senofilcon A 8.8 BC All subjects wore each of the lenses at a point in the study as this was a contralateral study.
New Lens Power Fit Match to Control Lenses Lens Power the Same	98 percentage of eyes	98 percentage of eyes	98 percentage of eyes	98 percentage of eyes	—	—
New Lens Power Fit Match to Control Lenses Lens Power Not the Same	2 percentage of eyes	2 percentage of eyes	2 percentage of eyes	2 percentage of eyes	—	—

Adverse Events

All Arms, All Interventions

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

Kathy Osborn, OD

Johnson & Johnson Vision Care

Phone: 1-904-443-1032

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication requires agreement and written authorization from Sponsor.
Publication restrictions are in place

Restriction type: OTHER