Trial Outcomes & Findings for Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses (NCT NCT02366923)

NCT ID: NCT02366923

Last Updated: 2020-07-29

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

Target enrollment

28 participants

Primary outcome timeframe

12 Hours of Wear

Results posted on

2020-07-29

Participant Flow

Participant milestones

Participant milestones
Measure	Overall Participants Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table. stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table
Overall Study STARTED	28
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Participants Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table. stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table
Overall Study Withdrawal by Subject	1
Overall Study Positive Slit Lamp Findings	2
Overall Study High Astigmatism	3

Baseline Characteristics

Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Participants n=22 Participants Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table. stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table
Age, Continuous	25 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Hours of Wear

Population: There were outliers across four participants in five lenses due to the fact that the weight of the worn lens after 12 hours was greater than the baseline weight of the lens from the blister pack. 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

Outcome measures
Measure	Stenfilcon 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). stenfilcon 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 Stenfilcon A and Delefilcon A	2.82 absolute WC change Standard Deviation 1.31	2.91 absolute WC change Standard Deviation 2.31

PRIMARY outcome

Timeframe: 12 Hours of Wear

Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).

Outcome measures

Outcome measures
Measure	Stenfilcon 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). stenfilcon 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 Stenfilcon A and Delefilcon A	2.76 absolute WC change Interval 0.0 to 6.11	2.35 absolute WC change Interval 0.3 to 8.03

PRIMARY outcome

Timeframe: 12 Hours of Wear

Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).

Outcome measures

Outcome measures
Measure	Stenfilcon 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). stenfilcon 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 Stenfilcon A and Delefilcon A	5.22 percentage of dehyrdation Standard Deviation 2.42	9.21 percentage of dehyrdation Standard Deviation 7.38

PRIMARY outcome

Timeframe: 12 Hours of Wear

Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).

Outcome measures

Outcome measures
Measure	Stenfilcon 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). stenfilcon 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 Stenfilcon A and Delefilcon A	5.15 percentage of dehyrdation Interval 0.0 to 11.29	7.41 percentage of dehyrdation Interval 1.02 to 25.81

SECONDARY outcome

Timeframe: Up to 12 Hours of Wear

Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)

Outcome measures

Outcome measures
Measure	Stenfilcon A n=22 Participants Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design). stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye.	Delefilcon A n=22 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.
Subjective Comfort of Stenfilcon A and Delefilcon A 0 HR	92.0 units on a scale Standard Deviation 11.5	93.9 units on a scale Standard Deviation 8.4
Subjective Comfort of Stenfilcon A and Delefilcon A 1 HR	90.5 units on a scale Standard Deviation 8.4	92.8 units on a scale Standard Deviation 8.6
Subjective Comfort of Stenfilcon A and Delefilcon A 2 HR	90.9 units on a scale Standard Deviation 8.8	93.6 units on a scale Standard Deviation 6.2
Subjective Comfort of Stenfilcon A and Delefilcon A 3 HR	89.8 units on a scale Standard Deviation 10.9	92.7 units on a scale Standard Deviation 7.0
Subjective Comfort of Stenfilcon A and Delefilcon A 4 HR	89.7 units on a scale Standard Deviation 9.3	91.8 units on a scale Standard Deviation 8.0
Subjective Comfort of Stenfilcon A and Delefilcon A 5 HR	89.1 units on a scale Standard Deviation 9.5	90.6 units on a scale Standard Deviation 8.4
Subjective Comfort of Stenfilcon A and Delefilcon A 6 HR	87.5 units on a scale Standard Deviation 10.4	91.8 units on a scale Standard Deviation 7.8
Subjective Comfort of Stenfilcon A and Delefilcon A 7 HR	86.8 units on a scale Standard Deviation 10.4	89.5 units on a scale Standard Deviation 10.0
Subjective Comfort of Stenfilcon A and Delefilcon A 8 HR	84.7 units on a scale Standard Deviation 10.5	87.2 units on a scale Standard Deviation 10.7
Subjective Comfort of Stenfilcon A and Delefilcon A 9 HR	83.0 units on a scale Standard Deviation 11.6	85.6 units on a scale Standard Deviation 12.6
Subjective Comfort of Stenfilcon A and Delefilcon A 10 HR	80.9 units on a scale Standard Deviation 12.0	83.9 units on a scale Standard Deviation 13.4
Subjective Comfort of Stenfilcon A and Delefilcon A 11 HR	78.0 units on a scale Standard Deviation 14.8	81.4 units on a scale Standard Deviation 15.2
Subjective Comfort of Stenfilcon A and Delefilcon A 12 HR	75.5 units on a scale Standard Deviation 16.2	81.1 units on a scale Standard Deviation 14.7

Adverse Events

Overall Participants

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