Trial Outcomes & Findings for Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens (NCT NCT01094743)

NCT ID: NCT01094743

Last Updated: 2018-06-19

Results Overview

Snellen monocular visual acuity measurement

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 52 participants
• Primary outcome timeframe: after 1 week of lens wear
• Results posted on: 2018-06-19

Participant Flow

Participant milestones

Measure	Galyfilcon A Prototype Lens / Lotrafilcon B Lens All enrolled subjects were to wear both lenses through the course of the study.
Period 1 STARTED	52
Period 1 COMPLETED	50
Period 1 NOT COMPLETED	2
Period 2 STARTED	50
Period 2 COMPLETED	50
Period 2 NOT COMPLETED	0

Reasons for withdrawal

Measure	Galyfilcon A Prototype Lens / Lotrafilcon B Lens All enrolled subjects were to wear both lenses through the course of the study.
Period 1 Unsatisfactory comfort at lens fitting	2

Baseline Characteristics

Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens

Baseline characteristics by cohort

Measure	Galyfilcon A Prototype Lens / Lotrafilcon B Lens n=52 Participants All enrolled subjects were to wear both lenses through the course of the study.
Age, Continuous	28 years STANDARD_DEVIATION 5.76 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: All completed subjects

Snellen monocular visual acuity measurement

Outcome measures

Measure	Galyfilcon A Prototype n=100 eyes All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.	Lotrafilcon B n=100 eyes All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Visual Acuity Monocular 20/15 monocular	59 eyes	64 eyes
Visual Acuity Monocular 20/20 monocular	40 eyes	30 eyes
Visual Acuity Monocular 20/25 monocular	1 eyes	5 eyes
Visual Acuity Monocular 20/30 monocular	0 eyes	1 eyes

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: All completed subjects

Snellen binocular visual acuity measurement

Outcome measures

Measure	Galyfilcon A Prototype n=50 Participants All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.	Lotrafilcon B n=50 Participants All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Visual Acuity Binocular 20/15 binocular	40 participants	42 participants
Visual Acuity Binocular 20/20 binocular	10 participants	8 participants

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: Completed subjects

Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

Outcome measures

Measure	Galyfilcon A Prototype n=50 Participants All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.	Lotrafilcon B n=50 Participants All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Subjective Assessment of Lens Comfort	66.23 units on a scale Standard Deviation 24.112	55 units on a scale Standard Deviation 21.844

PRIMARY outcome

Timeframe: after 1 week of lens wear

Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

Outcome measures

Measure	Galyfilcon A Prototype n=50 Participants All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.	Lotrafilcon B n=50 Participants All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Subjective Assessment of Quality of Vision	63.22 units on a scale Standard Deviation 25.345	59.83 units on a scale Standard Deviation 20.036

SECONDARY outcome

Timeframe: after 1 week of lens wear

Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

Outcome measures

Measure	Galyfilcon A Prototype n=100 eyes All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.	Lotrafilcon B n=100 eyes All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Limbal Redness Grade 0 None	37 eyes	35 eyes
Limbal Redness Grade 1 Trace	61 eyes	61 eyes
Limbal Redness Grade 2 Mild	2 eyes	4 eyes

SECONDARY outcome

Timeframe: after 1 week of lens wear

Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

Outcome measures

Measure	Galyfilcon A Prototype n=100 eyes All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.	Lotrafilcon B n=100 eyes All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Bulbar Redness Grade 0 None	44 eyes	34 eyes
Bulbar Redness Grade 1 Trace	50 eyes	64 eyes
Bulbar Redness Grade 2 Mild	6 eyes	2 eyes

SECONDARY outcome

Timeframe: 10 minutes after lens insertion at time of initial lens fitting

Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

Outcome measures

Measure	Galyfilcon A Prototype n=50 Participants All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.	Lotrafilcon B n=50 Participants All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
Subjective Assessment of Lens Comfort	76.67 units on a scale Standard Deviation 18.487	65 units on a scale Standard Deviation 19.842

Adverse Events

Galyfilcon A Prototype Lens / Lotrafilcon B Lens

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

Huan Sheng, MD, PhD

Johnson & Johnson Vision Care

Phone: 1-904-443-3440

Email: HSheng2@its.jnj.com

Results disclosure agreements

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

Restriction type: OTHER