Trial Outcomes & Findings for A Comparison of Two Daily Disposable Contact Lenses (NCT NCT00600080)

Results Overview

Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (\< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

2-week

Results posted on

2015-05-21

Participant Flow

Sixty subjects were enrolled onto the study to wear contact lenses for two weeks on a daily wear basis.

Sixty subjects enrolled and sixty subjects completed.

Participant milestones

Participant milestones
Measure	Etafilcon A/Nelfilcon A etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2.	Nelfilcon A/Etafilcon A nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2.
Period 1: Baseline to One-week STARTED	28	32
Period 1: Baseline to One-week COMPLETED	28	32
Period 1: Baseline to One-week NOT COMPLETED	0	0
Period 2: One-week to Two-weeks STARTED	28	32
Period 2: One-week to Two-weeks COMPLETED	28	32
Period 2: One-week to Two-weeks NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of Two Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=60 Participants All subjects crossed over to use each treatment for one week
Age, Continuous	29.6 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United Kingdom	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 2-week

Population: Subjects analyzed are those who were enrolled, randomized to a study arm, and completed the study.

Measured using high contrast and low contrast vision charts without the use of spectacles (glasses) or refraction equipment (for contact lens wearers). Values are on the logMar scale where lower values (\< 0) refer to 'better' values of sight. These scores are converted from a Snellen eye chart examination.

Outcome measures

Outcome measures
Measure	Nelfilcon A n=60 Participants All subjects who wore nelfilcon A lenses for one week	Etafilcon A n=60 Participants All subjects who wore etafilcon A lenses for one week
Visual Acuity High Contrast	-0.10 logMAR scale Standard Deviation 0.07	-0.10 logMAR scale Standard Deviation 0.07
Visual Acuity Low Contrast	0.17 logMAR scale Standard Deviation 0.09	0.18 logMAR scale Standard Deviation 0.09

PRIMARY outcome

Timeframe: 2-week

Population: Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.

Outcome measures

Outcome measures
Measure	Nelfilcon A n=60 Participants All subjects who wore nelfilcon A lenses for one week	Etafilcon A n=60 Participants All subjects who wore etafilcon A lenses for one week
Subjective Lens Comfort	86.0 units on a scale Standard Deviation 13.9	88.2 units on a scale Standard Deviation 12.4

SECONDARY outcome

Timeframe: 2-week

Population: Analyzed subjects were those who were enrolled and randomized to a study arm.

Subjects were asked to rate lens performance on a scale of 0 to 100 point scale (0= "Extremely poor" or "Cannot use lenses" and 100= "Excellent" or "Highly impressed with these lenses overall"). The average score is reported. A factor analysis was used to identify the questions pertaining to product performance, a factor loading of 0.4 or greater was used.

Outcome measures

Outcome measures
Measure	Nelfilcon A n=60 Participants All subjects who wore nelfilcon A lenses for one week	Etafilcon A n=60 Participants All subjects who wore etafilcon A lenses for one week
Subject-reported Overall Product Performance	86.5 units on a scale Standard Error 11.3	87.7 units on a scale Standard Error 12.3

SECONDARY outcome

Timeframe: Baseline, 1-week, 2-week

Population: Subjects analyzed were those who were enrolled, randomized to a study arm, and completed the study.

Number of subjects that measured as an optimum fit. Lens fit will be assessed using the following evaluations: horizontal and vertical centration, corneal coverage and movement. Normally, for an acceptable fit, centration and movement will fall within currently accepted clinical criteria \[between -1 and +1 on a -2 to +2 grading scale.

Outcome measures

Outcome measures
Measure	Nelfilcon A n=60 Participants All subjects who wore nelfilcon A lenses for one week	Etafilcon A n=60 Participants All subjects who wore etafilcon A lenses for one week
Optimum Lens Fit At Dispensing	22 participants	18 participants
Optimum Lens Fit At Follow-up	18 participants	18 participants

Adverse Events

Etafilcon A First Nelfilcon A Second

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nelfilcon A First Etafilcon A Second

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

Kurt Moody, OD

Johnson & Johnson Vision Care

Phone: +1 904 443-3088

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