Trial Outcomes & Findings for Clinical Evaluation of an Investigational Soft Contact Lens (NCT NCT01254747)

NCT ID: NCT01254747

Last Updated: 2012-07-10

Results Overview

Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 130 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2012-07-10

Participant Flow

Participants were recruited and enrolled from 1 US study center and 1 German study center.

This reporting group includes all enrolled and dispensed participants (129). One US participant was enrolled, but not dispensed.

Participant milestones

Measure	Delefilcon A Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Overall Study STARTED	40	29	30	30
Overall Study COMPLETED	40	23	26	28
Overall Study NOT COMPLETED	0	6	4	2

Reasons for withdrawal

Measure	Delefilcon A Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Overall Study Unacceptable subjective vision	0	0	0	2
Overall Study Difficult removal handling	0	0	1	0
Overall Study Symptoms and problems	0	2	1	0
Overall Study Lost to Follow-up	0	0	1	0
Overall Study Biomicroscopy	0	0	1	0
Overall Study Discomfort	0	4	0	0

Baseline Characteristics

Clinical Evaluation of an Investigational Soft Contact Lens

Baseline characteristics by cohort

Measure	Delefilcon A n=40 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B n=29 Participants Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A n=30 Participants Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A n=30 Participants Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Total n=129 Participants Total of all reporting groups
Age Continuous	35.7 years STANDARD_DEVIATION 10.4 • n=5 Participants	35.6 years STANDARD_DEVIATION 11.4 • n=7 Participants	38.4 years STANDARD_DEVIATION 10.6 • n=5 Participants	37.0 years STANDARD_DEVIATION 11.4 • n=4 Participants	36.6 years STANDARD_DEVIATION 10.8 • n=21 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	19 Participants n=7 Participants	24 Participants n=5 Participants	20 Participants n=4 Participants	95 Participants n=21 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	34 Participants n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Overall comfort was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Delefilcon A n=40 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B n=23 Participants Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A n=26 Participants Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A n=28 Participants Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Overall Comfort	9.5 Units on a scale Standard Deviation 0.7	7.9 Units on a scale Standard Deviation 1.6	9.0 Units on a scale Standard Deviation 0.9	8.6 Units on a scale Standard Deviation 1.2

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Vision quality during the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Vision quality during the day was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Delefilcon A n=40 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B n=23 Participants Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A n=26 Participants Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A n=28 Participants Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Vision Quality During the Day	9.6 Units on a scale Standard Deviation 0.6	8.8 Units on a scale Standard Deviation 1.2	9.5 Units on a scale Standard Deviation 0.9	8.7 Units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Overall handling was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall handling was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Delefilcon A n=40 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B n=23 Participants Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A n=26 Participants Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A n=28 Participants Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Overall Handling	9.3 Units on a scale Standard Deviation 0.9	8.5 Units on a scale Standard Deviation 1.4	9.3 Units on a scale Standard Deviation 0.9	9.1 Units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Dryness throughout the day was assessed and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Dryness throughout the day was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

Outcome measures

Measure	Delefilcon A n=40 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B n=23 Participants Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A n=26 Participants Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A n=28 Participants Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Dryness Throughout the Day	9.5 Units on a scale Standard Deviation 0.6	7.7 Units on a scale Standard Deviation 2.0	9.0 Units on a scale Standard Deviation 1.5	8.5 Units on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Average daily wear time (hours) was reported by the participant as a single, retrospective evaluation of 4 weeks of wear.

Outcome measures

Measure	Delefilcon A n=40 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B n=23 Participants Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A n=26 Participants Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A n=28 Participants Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Average Daily Wear Time	13.8 Hours Standard Deviation 2.2	13.8 Hours Standard Deviation 2.1	14.2 Hours Standard Deviation 1.8	13.8 Hours Standard Deviation 1.6

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Lens fit was assessed by the investigator for each eye using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded on a 5-point scale, with 2=unacceptable loose, 1=acceptable loose, 0=optimal, -1=acceptable tight, and -2=unacceptable tight.

Outcome measures

Measure	Delefilcon A n=80 Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B n=46 Eyes Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A n=52 Eyes Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A n=56 Eyes Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Lens Fit	0.1 Units on a scale Standard Deviation 0.3	0.1 Units on a scale Standard Deviation 0.6	0.1 Units on a scale Standard Deviation 0.6	-0.6 Units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Corrected visual acuity was tested for each eye while the participant read distant charts in normal lighting. Corrected visual acuity was measured with a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.

Outcome measures

Measure	Delefilcon A n=80 Eyes Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B n=46 Eyes Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A n=52 Eyes Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A n=56 Eyes Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Corrected Visual Acuity	-0.06 logMAR Standard Deviation 0.04	-0.04 logMAR Standard Deviation 0.06	-0.07 logMAR Standard Deviation 0.05	-0.06 logMAR Standard Deviation 0.06

SECONDARY outcome

Timeframe: 4 weeks

Population: Analysis conducted per protocol, with exclusions due to reasons such as protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Overall satisfaction was recorded on a 5-point Likert scale as a single, retrospective evaluation of 4 weeks of wear. The following scale was used: 2=very satisfied, 1=somewhat satisfied, 0=neither, -1=somewhat dissatisfied, and -2=very dissatisfied.

Outcome measures

Measure	Delefilcon A n=40 Participants Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B n=23 Participants Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A n=26 Participants Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A n=28 Participants Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Overall Satisfaction	1.4 Units on a scale Standard Deviation 1.3	0.6 Units on a scale Standard Deviation 1.4	1.5 Units on a scale Standard Deviation 0.8	1.1 Units on a scale Standard Deviation 1.0

Adverse Events

Delefilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lotrafilcon B

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Nelfilcon A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Narafilcon A

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Delefilcon A n=40 participants at risk Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Lotrafilcon B n=29 participants at risk Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Nelfilcon A n=30 participants at risk Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.	Narafilcon A n=30 participants at risk Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
Eye disorders Contact Lens-Related Discomfort	0.00% 0/40 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.	17.2% 5/29 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.	0.00% 0/30 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.	0.00% 0/30 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.
Eye disorders Contact Lens-Related Dryness	0.00% 0/40 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.	0.00% 0/29 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.	6.7% 2/30 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.	0.00% 0/30 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.
Eye disorders Contact Lens-Related Unacceptable Subjective Vision	0.00% 0/40 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.	0.00% 0/29 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.	0.00% 0/30 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.	6.7% 2/30 • Adverse events were collected for the duration of the trial: 15-NOV-2010 to 20-DEC-2010. The safety population included all enrolled and exposed participants: 129.

Additional Information

Director of Alcon Clinical, Atlanta

Alcon Research

Phone: 1-800-241-7629

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place