Trial Outcomes & Findings for Dehydration of Omafilcon A Contact Lenses Versus Delefilcon A Contact Lenses (NCT NCT02366910)
NCT ID: NCT02366910
Last Updated: 2020-07-31
Results Overview
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
12 Hours of Wear
Results posted on
2020-07-31
Participant Flow
Participant milestones
| Measure |
Overall Participants
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Overall Participants
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Screen Failure
|
3
|
Baseline Characteristics
Dehydration of Omafilcon A Contact Lenses Versus Delefilcon A Contact Lenses
Baseline characteristics by cohort
| Measure |
Overall Participants
n=21 Participants
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
|
|---|---|
|
Age, Continuous
|
24 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 Hours of WearPopulation: Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Outcome measures
| Measure |
Omafilcon A
n=18 Participants
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
|
Delefilcon A
n=18 Participants
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
|
|---|---|---|
|
Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A
|
1.59 absolute WC change
Standard Deviation 0.85
|
3.82 absolute WC change
Standard Deviation 1.75
|
PRIMARY outcome
Timeframe: 12 Hours of WearPopulation: Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Outcome measures
| Measure |
Omafilcon A
n=18 Participants
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
|
Delefilcon A
n=18 Participants
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
|
|---|---|---|
|
Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A
|
1.20 absolute WC change
Interval 0.21 to 3.01
|
3.38 absolute WC change
Interval 0.37 to 7.25
|
PRIMARY outcome
Timeframe: 12 HoursPopulation: Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Outcome measures
| Measure |
Omafilcon A
n=18 Participants
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
|
Delefilcon A
n=18 Participants
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
|
|---|---|---|
|
Moisture Retention (Mean) of Omafilcon A and Delefilcon A
|
2.58 percentage of dehyrdation
Standard Deviation 1.38
|
11.5 percentage of dehyrdation
Standard Deviation 5.2
|
PRIMARY outcome
Timeframe: 12 HoursPopulation: Because of the outliers across three participants, the sample size for statistical analysis is reduced to 18 pairs.
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Outcome measures
| Measure |
Omafilcon A
n=18 Participants
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
|
Delefilcon A
n=18 Participants
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye.
|
|---|---|---|
|
Moisture Retention (Median) of Omafilcon A and Delefilcon A
|
1.98 percentage of dehyrdation
Interval 0.35 to 4.9
|
9.89 percentage of dehyrdation
Interval 1.18 to 21.44
|
Adverse Events
Omafilcon A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delefilcon 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
Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs
Coopervision
Phone: (925) 621-3761
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are NOT employed by the organization sponsoring the study. There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
- Publication restrictions are in place
Restriction type: OTHER