Trial Outcomes & Findings for Prospective Study of an Investigational Daily Disposable Contact Lens (NCT NCT01295905)

NCT ID: NCT01295905

Last Updated: 2012-07-10

Results Overview

Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: 3 months of wear, lenses replaced daily
• Results posted on: 2012-07-10

Participant Flow

Participants were recruited and enrolled from six (6) US study centers.

This reporting group includes all enrolled participants.

Participant milestones

Measure	Delefilcon A Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Narafilcon B Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Overall Study STARTED	60	30
Overall Study COMPLETED	58	30
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Delefilcon A Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Narafilcon B Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Overall Study Did not meet inclusion criteria	1	0
Overall Study Met exclusion criteria	1	0

Baseline Characteristics

Prospective Study of an Investigational Daily Disposable Contact Lens

Baseline characteristics by cohort

Measure	Delefilcon A n=60 Participants Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Narafilcon B n=30 Participants Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Total n=90 Participants Total of all reporting groups
Age Continuous	29.01 years STANDARD_DEVIATION 8.86 • n=93 Participants	31.39 years STANDARD_DEVIATION 10.05 • n=4 Participants	29.80 years STANDARD_DEVIATION 9.29 • n=27 Participants
Sex: Female, Male Female	40 Participants n=93 Participants	19 Participants n=4 Participants	59 Participants n=27 Participants
Sex: Female, Male Male	20 Participants n=93 Participants	11 Participants n=4 Participants	31 Participants n=27 Participants
Region of Enrollment United States	60 participants n=93 Participants	30 participants n=4 Participants	90 participants n=27 Participants

PRIMARY outcome

Timeframe: 3 months of wear, lenses replaced daily

Population: Per protocol.

Each eye tested individually while reading a chart distant to the participant in normal lighting. Visual acuity was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. Visual acuity is reported as the number of eyes achieving 20/20 Snellen acuity or better.

Outcome measures

Measure	Delefilcon A n=116 eyes Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Narafilcon B n=60 eyes Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Corrected Distance Monocular Visual Measurement in Normal Illumination Reported as Visual Acuity	111 eyes	58 eyes

SECONDARY outcome

Timeframe: 3 months of wear, lenses replaced daily

Population: Per protocol.

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Delefilcon A n=58 Participants Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Narafilcon B n=30 Participants Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Overall Vision	9.5 Units on a scale Standard Deviation 0.8	9.1 Units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 3 months of wear, lenses replaced daily

Population: Per protocol.

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months 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

Measure	Delefilcon A n=58 Participants Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Narafilcon B n=30 Participants Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Overall Comfort	9.3 Units on a scale Standard Deviation 0.9	8.9 Units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 3 months of wear, lenses replaced daily

Population: Per protocol.

As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall handling was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Delefilcon A n=58 Participants Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Narafilcon B n=30 Participants Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Overall Handling	9.1 Units on a scale Standard Deviation 1.3	9.1 Units on a scale Standard Deviation 1.2

Adverse Events

Delefilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Narafilcon B

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Delefilcon A n=60 participants at risk Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.	Narafilcon B n=30 participants at risk Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
Eye disorders Sterile infiltrate with secondary iritis	0.00% 0/60 • Adverse events were collected for the duration of the study: 19-JAN-2011 to 20-MAY-2011. This reporting group includes all enrolled and exposed participants.	3.3% 1/30 • Adverse events were collected for the duration of the study: 19-JAN-2011 to 20-MAY-2011. This reporting group includes all enrolled and exposed participants.

Other adverse events

Adverse event data not reported

Additional Information

Director of Alcon Clinical, Atlanta

Alcon Research

Phone: 1-800-241-7629

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