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Trial Outcomes & Findings for A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses (NCT NCT03306641)

NCT ID: NCT03306641

Last Updated: 2020-09-22

Results Overview

Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

Baseline

Results posted on

2020-09-22

Participant Flow

Participant milestones

Participant milestones
Measure
Test Contact Lens Then Nelfilcon A Lens (Control)
Per randomized schedule, subject will wear a pair of the test lens for one week and then cross-over with the control pair for 1 week. Test Contact Lens: Daily disposable contact lens Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Nelfilcon A Lens (Control) Then Test Contact Lens
Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week. Test Contact Lens: Daily disposable contact lens Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)
First Intervention
STARTED
23
22
First Intervention
COMPLETED
23
22
First Intervention
NOT COMPLETED
0
0
Second Intervention
STARTED
23
22
Second Intervention
COMPLETED
23
22
Second Intervention
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Overall Study
n=45 Participants
Per randomized schedule, subject will wear either a pair of the test lens or control lens for one week and then cross-over to the other pair for 1 week. Test Contact Lens: Daily disposable contact lens Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Age, Categorical
<=18 years
0 Participants
n=45 Participants
Age, Categorical
Between 18 and 65 years
45 Participants
n=45 Participants
Age, Categorical
>=65 years
0 Participants
n=45 Participants
Age, Continuous
26 years
STANDARD_DEVIATION 8 • n=45 Participants
Sex: Female, Male
Female
32 Participants
n=45 Participants
Sex: Female, Male
Male
13 Participants
n=45 Participants
Region of Enrollment
United States
45 participants
n=45 Participants

PRIMARY outcome

Timeframe: Baseline

Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

Outcome measures

Outcome measures
Measure
Test Contact Lens
n=45 Participants
Per randomized schedule, subject will wear a pair of the test lens for one week in this cross-over study. Test Contact Lens: Daily disposable contact lens
Nelfilcon A Lens (Control)
n=45 Participants
Per randomized schedule, subject will wear a pair of the control lens for one week in this cross-over study. Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Lens Fit Acceptance
2.6 units on a scale
Standard Deviation 0.6
3.1 units on a scale
Standard Deviation 0.3

PRIMARY outcome

Timeframe: 1-Week

Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

Outcome measures

Outcome measures
Measure
Test Contact Lens
n=45 Participants
Per randomized schedule, subject will wear a pair of the test lens for one week in this cross-over study. Test Contact Lens: Daily disposable contact lens
Nelfilcon A Lens (Control)
n=45 Participants
Per randomized schedule, subject will wear a pair of the control lens for one week in this cross-over study. Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Lens Fit Acceptance
2.6 units on a scale
Standard Deviation 0.6
3.0 units on a scale
Standard Deviation 0.4

Adverse Events

Test Contact Lens

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

Nelfilcon A Lens (Control)

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

Lee Hall, BSc, PhD, MCOptom, FBCLA

CooperVision, Inc

Phone: 925 251 6684

Results disclosure agreements

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