Trial Outcomes & Findings for A Clinical Comparison of Two Daily Disposable Contact Lenses. (NCT NCT00775021)

NCT ID: NCT00775021

Last Updated: 2018-06-19

Results Overview

Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 123 participants
• Primary outcome timeframe: 1 week
• Results posted on: 2018-06-19

Participant Flow

Participant milestones

Measure	Etafilcon A/Nelfilcon A etafilcon A contact lens worn first and nelfilcon A contact lens worn second	Nelfilcon A/Etafilcon A nelfilcon A contact lens worn first and etafilcon A contact lens second.
First Intervention STARTED	63	60
First Intervention COMPLETED	62	60
First Intervention NOT COMPLETED	1	0
Second Intervention STARTED	62	60
Second Intervention COMPLETED	62	59
Second Intervention NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Etafilcon A/Nelfilcon A etafilcon A contact lens worn first and nelfilcon A contact lens worn second	Nelfilcon A/Etafilcon A nelfilcon A contact lens worn first and etafilcon A contact lens second.
First Intervention Lost to Follow-up	1	0
Second Intervention Adverse Event	0	1

Baseline Characteristics

A Clinical Comparison of Two Daily Disposable Contact Lenses.

Baseline characteristics by cohort

Measure	Total Participants n=121 Participants Total number of participants that completed the study.
Age, Continuous	28.7 years STANDARD_DEVIATION 8.5 • n=93 Participants
Sex: Female, Male Female	80 Participants n=93 Participants
Sex: Female, Male Male	41 Participants n=93 Participants
Region of Enrollment United Kingdom	121 participants n=93 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Analysis includes all participants that completed the study.

Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Outcome measures

Measure	Etafilcon A n=121 Participants All subjects that wore etafilcon A contact lenses and completed the study.	Nelfilcon A n=121 Participants All subjects that wore nelfilcon A contact lenses and completed the study.
Overall Comfort	3.6685 units on a scale Standard Error 0.1141	3.4352 units on a scale Standard Error 0.1148

SECONDARY outcome

Timeframe: 1 week

Population: Analysis includes all participants that completed the study.

The investigator assessed abrasion to the lower portion of the cornea using the following scale:0 = None 1 = Slight micropunctate (1-10 spots) 2 = Moderate micropunctate (11-20 spots) 3 = Severe micropunctate (>20 spots)4 = Slight macropunctate (1-5 spots) 5 = Moderate macropuntate (>5-10 spots) 6 = Severe macropunctate (>10 spots) 7 = Slight patch (1-2mm)8 = Moderate patch (>2-4mm) 9 = Severe patch (>4mm)

Outcome measures

Measure	Etafilcon A n=121 Participants All subjects that wore etafilcon A contact lenses and completed the study.	Nelfilcon A n=121 Participants All subjects that wore nelfilcon A contact lenses and completed the study.
Inferior Region Corneal Staining	0.7004 units on a scale Standard Error 0.0643	0.8085 units on a scale Standard Error 0.0643

SECONDARY outcome

Timeframe: 1 week

Population: Analysis includes all participants that completed the study.

Subjects rated study contact lens comfort at the end of a day of lens wear using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Outcome measures

Measure	Etafilcon A n=121 Participants All subjects that wore etafilcon A contact lenses and completed the study.	Nelfilcon A n=121 Participants All subjects that wore nelfilcon A contact lenses and completed the study.
End of the Day Comfort	3.148 units on a scale Standard Error 0.127	2.7479 units on a scale Standard Error 0.1274

SECONDARY outcome

Timeframe: 1 Week

Population: Analysis includes all participants that completed the study.

Subjects rated study contact lens for comfort immediately when they first put the lenses on using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Outcome measures

Measure	Etafilcon A n=121 Participants All subjects that wore etafilcon A contact lenses and completed the study.	Nelfilcon A n=121 Participants All subjects that wore nelfilcon A contact lenses and completed the study.
Initial Comfort	3.5694 units on a scale Standard Error 0.1229	3.6783 units on a scale Standard Error 0.1233

SECONDARY outcome

Timeframe: 1 week

Population: Analysis includes all participants that completed the study.

Subjects rated study contact lens for overall ease of handling using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

Outcome measures

Measure	Etafilcon A n=121 Participants All subjects that wore etafilcon A contact lenses and completed the study.	Nelfilcon A n=121 Participants All subjects that wore nelfilcon A contact lenses and completed the study.
Overall Lens Handling	3.546 units on a scale Standard Error 0.1189	3.2971 units on a scale Standard Error 0.1187

Adverse Events

Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nelfilcon 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

Kurt Moody, Director Design R&D

Vistakon

Phone: 904-443-3088

Results disclosure agreements

• Principal investigator is a sponsor employee The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
• Publication restrictions are in place

Restriction type: OTHER