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Trial Outcomes & Findings for Clinical Evaluation of Two Daily Disposable Contact Lenses (NCT NCT01163760)

NCT ID: NCT01163760

Last Updated: 2018-06-19

Results Overview

Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

1-week follow-up

Results posted on

2018-06-19

Participant Flow

There were 50 subjects enrolled in this single site study, located at Singapore University.

There were 50 patients enrolled and randomized, and 50 patients completed the study.

Participant milestones

Participant milestones
Measure
Etafilcon A First, Then Ocufilcon D
etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
Ocufilcon D First, Then Etafilcon A
ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
Etafilcon A First, Then Etafilcon A
etafilcon A contact lenses worn for both periods.
Ocufilcon D First, Then Ocufilcon D
Ocufilcon D contact lenses worn for both periods.
Period 1 (Fit)
STARTED
12
13
13
12
Period 1 (Fit)
COMPLETED
12
13
13
12
Period 1 (Fit)
NOT COMPLETED
0
0
0
0
Period 2 (Follow-up)
STARTED
12
13
13
12
Period 2 (Follow-up)
COMPLETED
12
13
13
12
Period 2 (Follow-up)
NOT COMPLETED
0
0
0
0
Period 3 (Fit)
STARTED
12
13
13
12
Period 3 (Fit)
COMPLETED
12
13
13
12
Period 3 (Fit)
NOT COMPLETED
0
0
0
0
Period 4 (Follow-up)
STARTED
12
13
13
12
Period 4 (Follow-up)
COMPLETED
12
13
13
12
Period 4 (Follow-up)
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Two Daily Disposable Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall
n=50 Participants
Total number of completed participants are included in baseline measurements.
Age, Continuous
25.0 years
STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male
Female
31 Participants
n=5 Participants
Sex: Female, Male
Male
19 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1-week follow-up

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

Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)

Outcome measures

Outcome measures
Measure
Etafilcon A
n=51 Participants
etafilcon A contact lenses worn in either the first or second period.
Ocufilcon D
n=49 Participants
ocufilcon D contact lenses worn in either the first or second period.
Lens Comfort
3.08 units on a scale
Standard Deviation 0.98
3.00 units on a scale
Standard Deviation 1.15

SECONDARY outcome

Timeframe: 1-week follow-up

Population: Subjects analyzed were those enrolled, randomized, and completed the study.

Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".

Outcome measures

Outcome measures
Measure
Etafilcon A
n=51 Participants
etafilcon A contact lenses worn in either the first or second period.
Ocufilcon D
n=49 Participants
ocufilcon D contact lenses worn in either the first or second period.
Comfort Throughout the Whole Day
39.2 percentage of participants
36.7 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1-week-follow-up

Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".

Outcome measures

Outcome measures
Measure
Etafilcon A
n=51 Participants
etafilcon A contact lenses worn in either the first or second period.
Ocufilcon D
n=49 Participants
ocufilcon D contact lenses worn in either the first or second period.
Comfort While Working on Computer
47.0 percentage of participants
42.9 percentage of participants

Adverse Events

Etafilcon A/ Ocufilcon D

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ocufilcon D / Etafilcon A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Etafilcon A/ Etafilcon A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Oculfilcon D / Ocufilcon D

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, FAAO

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