Trial Outcomes & Findings for Contact Lens Insertion and Removal in a Senior Subject Demographic (NCT NCT03597178)

Results Overview

The subject attempted to insert a contact lens in each eye. The subject were allowed to voluntarily end the contact lens insertion activity at any time prior to the 20-minute time point. The time of insertion for each eye or the time of stopping the insertion process for each eye was recorded. Similarly, the time of removal for each lens or the time of stopping the removal process for each lens was recorded.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Lens insertion and Removal, up to 2-Hours

Results posted on

2019-08-28

Participant Flow

A total of 16 subjects were enrolled into this study. Of those enrolled, 2 failed to meet all eligibility criteria. Of 14 dispensed subjects all completed the study.

Participant milestones

Participant milestones
Measure	Senofilcon A Subjects that wore senofilcon A during the entire duration of the study
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contact Lens Insertion and Removal in a Senior Subject Demographic

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Dispensed Subjects n=14 Participants All subjects dispensed a study lens.
Age, Continuous	65.3 Years STANDARD_DEVIATION 2.37 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Lens insertion and Removal, up to 2-Hours

Population: All subjects who successfully ompleted all study visits and did not substanially deviate from the protocol as deterined by the trial cohort review committee prior to database lock.

The subject attempted to insert a contact lens in each eye. The subject were allowed to voluntarily end the contact lens insertion activity at any time prior to the 20-minute time point. The time of insertion for each eye or the time of stopping the insertion process for each eye was recorded. Similarly, the time of removal for each lens or the time of stopping the removal process for each lens was recorded.

Outcome measures

Outcome measures
Measure	Senofilcon A n=28 Eyes Subjects that inserted and removed the senofilcon A lens.
Overall Success Rate of Insertion and Removal of a Contact Lens	85.7 Percentage of eyes

Adverse Events

Senofilcon 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

Brian Pall OD, MS, FAAO- Director of Clinical Sciences

Johnson & Johnson

Phone: 9044431290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60