Trial Outcomes & Findings for Feasibility Evaluation of Daily Disposable Toric Soft Contact Lenses Manufactured With an Alternative Hydration Process (NCT NCT05427539)

Results Overview

Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

66 participants

Primary outcome timeframe

Up to 1-Week Follow-up

Results posted on

2023-10-02

Participant Flow

A total of 66 subjects were enrolled in this study. Of those enrolled, 65 subjects were dispensed at least one study lens, while 1 subject failed to meet all eligibility criteria. Of those dispensed, 62 subjects completed the study while 3 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Senofilcon A Manufactured With PG Hydration\Senofilcon A Manufactured With IPA Hydration Subjects randomized to receive the senofilcon A contact lenses manufactured with PG hydration during the first period and senofilcon A manufactured with IPA hydration during the second period.	Senofilcon A Manufactured With IPA Hydration\Senofilcon A Manufactured With PG Hydration Subjects randomized to receive the senofilcon A contact lenses manufactured with IPA hydration during the first period and senofilcon A manufactured with PG hydration during the second period.
Period 1 STARTED	31	34
Period 1 COMPLETED	29	33
Period 1 NOT COMPLETED	2	1
Period 2 STARTED	29	33
Period 2 COMPLETED	29	33
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Senofilcon A Manufactured With PG Hydration\Senofilcon A Manufactured With IPA Hydration Subjects randomized to receive the senofilcon A contact lenses manufactured with PG hydration during the first period and senofilcon A manufactured with IPA hydration during the second period.	Senofilcon A Manufactured With IPA Hydration\Senofilcon A Manufactured With PG Hydration Subjects randomized to receive the senofilcon A contact lenses manufactured with IPA hydration during the first period and senofilcon A manufactured with PG hydration during the second period.
Period 1 Unsatisfactory Lens Fitting due to Test Article	1	1
Period 1 Withdrawal by Subject	1	0

Baseline Characteristics

Feasibility Evaluation of Daily Disposable Toric Soft Contact Lenses Manufactured With an Alternative Hydration Process

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total n=65 Participants Total Subjects
Age, Continuous	30.4 years STANDARD_DEVIATION 5.59 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants
Race/Ethnicity, Customized White	57 Participants n=5 Participants
Region of Enrollment United States	65 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1-Week Follow-up

Population: All subjects that were dispensed at least one study lens.

Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported.

Outcome measures

Outcome measures
Measure	Senofilcon A Manufactured With PG Hydration n=128 eyes Subjects that wore the senofilcon A contact lenses manufactured with PG hydration during either the first or second period of the study.	Senofilcon A Manufactured With IPA Hydration n=126 eyes Subjects that wore the senofilcon A contact lenses manufactured with IPA hydration during either the first or second period of the study.
Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings	0 proportion of eyes	0 proportion of eyes

Adverse Events

Senofilcon A Manufactured With PG Hydration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Senofilcon A Manufactured With IPA Hydration

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

Ben Straker

Johnson & Johnson Vision Care, Inc. (JJVC)

Phone: 1-800-843-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place