Trial Outcomes & Findings for Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses (NCT NCT01362907)

NCT ID: NCT01362907

Last Updated: 2012-08-03

Results Overview

As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

1 week of wear, replacing lenses daily

Results posted on

2012-08-03

Participant Flow

Participants were recruited from 4 US private practices.

Participant milestones

Participant milestones
Measure	Delefilcon A / Etafilcon A Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.	Etafilcon A / Delefilcon A Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
Period 2, One Week COMPLETED	20	20
Period 2, One Week NOT COMPLETED	0	0
Period 1, One Week STARTED	20	20
Period 1, One Week COMPLETED	20	20
Period 1, One Week NOT COMPLETED	0	0
Period 2, One Week STARTED	20	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Comparison of Silicone Hydrogel and HEMA-based Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=40 Participants All enrolled participants
Age Continuous	32.7 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week of wear, replacing lenses daily

Population: All enrolled and dispensed participants.

As tested for each eye individually while wearing study lenses. VA was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. Positive logMAR values indicated poorer vision, and negative values denoted better visual acuity.

Outcome measures

Outcome measures
Measure	Delefilcon A n=40 Participants Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A n=80 eyes Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Corrected Distance Monocular Visual Measurement Reported as Visual Acuity (VA)	-0.02 logMAR Standard Deviation 0.06	-0.02 logMAR Standard Deviation 0.05

PRIMARY outcome

Timeframe: 1 week of wear, replacing lenses daily

Population: All enrolled and dispensed participants.

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Outcome measures
Measure	Delefilcon A n=40 Participants Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A n=40 Participants Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Comfort	9.0 Units on a scale Standard Deviation 1.5	8.1 Units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 1 week of wear, replacing lenses daily

Population: All enrolled and dispensed participants.

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall vision quality was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Outcome measures
Measure	Delefilcon A n=40 Participants Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A n=40 Participants Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Vision Quality	9.4 Units on a scale Standard Deviation 1.0	8.9 Units on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: 1 week of wear, replacing lenses daily

Population: All enrolled and dispensed participants.

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being difficult and 10 being easy.

Outcome measures

Outcome measures
Measure	Delefilcon A n=40 Participants Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A n=40 Participants Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Handling	8.5 Units on a scale Standard Deviation 1.9	8.6 Units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 1 week of wear, replacing lenses daily

Population: All enrolled and dispensed participants.

As assessed for each eye individually by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit is reported on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight.

Outcome measures

Outcome measures
Measure	Delefilcon A n=80 eyes Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.	Etafilcon A n=80 eyes Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
Overall Lens Fit	-0.1 Units on a scale Standard Deviation 0.5	0.1 Units on a scale Standard Deviation 0.3

Adverse Events

Delefilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A

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

Joachim Nick, Dipl. Ing. (FH)

Alcon Research

Phone: +49 6022 240 520

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
Publication restrictions are in place

Restriction type: OTHER