Trial Outcomes & Findings for Clinical Evaluation of Etafilcon A With Ketotifen (NCT NCT03388138)

Results Overview

Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

143 participants

Primary outcome timeframe

Baseline (Visit 1) and 1-week follow up (Visit 2)

Results posted on

2022-03-17

Participant Flow

A total of 143 subjects were enrolled into this study. Of those enrolled, 141 were dispensed a study lens and 2 subjects were enrolled but not dispensed. Of the dispensed subjects 140 completed the study and 1 discontinued from the study.

Participant milestones

Participant milestones
Measure	Etafilcon A With Ketotifen Subjects that were randomized to the etafilcon A with ketotifen contact lens throughout the entire duration of the study.	Etafilcon A Subjects that were randomized to the etafilcon A contact lens throughout the entire duration of the study.
Overall Study STARTED	94	47
Overall Study COMPLETED	93	47
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Etafilcon A With Ketotifen Subjects that were randomized to the etafilcon A with ketotifen contact lens throughout the entire duration of the study.	Etafilcon A Subjects that were randomized to the etafilcon A contact lens throughout the entire duration of the study.
Overall Study Protocol Violation	1	0

Baseline Characteristics

Clinical Evaluation of Etafilcon A With Ketotifen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etafilcon A With Ketotifen n=94 Participants Subjects that were randomized to the etafilcon A with ketotifen contact lens throughout the entire duration of the study.	Etafilcon A n=47 Participants Subjects that were randomized to the etafilcon A contact lens throughout the entire duration of the study.	Total n=141 Participants Total of all reporting groups
Age, Continuous	30.4 years STANDARD_DEVIATION 4.98 • n=5 Participants	29.6 years STANDARD_DEVIATION 4.56 • n=7 Participants	30.1 years STANDARD_DEVIATION 4.84 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	31 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	16 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White	83 Participants n=5 Participants	43 Participants n=7 Participants	126 Participants n=5 Participants
Region of Enrollment United States	94 participants n=5 Participants	47 participants n=7 Participants	141 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Visit 1) and 1-week follow up (Visit 2)

Population: Per-protocol (PP) population which consists of all subjects who completed the study without a major protocol deviation.

Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.

Outcome measures

Outcome measures
Measure	Etafilcon A With Ketotifen n=186 eyes Subjects that wore the etafilcon A with ketotifen contact lens throughout the entire duration of the study.	Etafilcon A n=92 eyes Subjects that wore the etafilcon A contact lens throughout the entire duration of the study.
Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population) Visit 1 (Baseline)	-0.111 logMAR Standard Deviation 0.0702	-0.109 logMAR Standard Deviation 0.0809
Monocular Contact Lens-corrected Distance Visual Acuity (Per-Protocol Population) Visit 2 (1-week follow up)	-0.115 logMAR Standard Deviation 0.0717	-0.118 logMAR Standard Deviation 0.0814

PRIMARY outcome

Timeframe: Baseline (Visit 1) and 1-week follow up (Visit 2)

Population: Modified intent-to-treat (MITT) which consists of all the subjects who were administered either study lens excluding subjects who drop out prior to administering any study article.

Monocular contact lens-corrected distance visual acuity was assessed using a logMAR visual acuity scale. This was evaluated for each eye, under high luminance and high contrast conditions at 4 meters from ETDRS charts. Distance visual acuity was reported by lens type and visit.

Outcome measures

Outcome measures
Measure	Etafilcon A With Ketotifen n=188 eyes Subjects that wore the etafilcon A with ketotifen contact lens throughout the entire duration of the study.	Etafilcon A n=94 eyes Subjects that wore the etafilcon A contact lens throughout the entire duration of the study.
Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population) Visit 1 (Baseline)	-0.109 logMAR Standard Deviation 0.0740	-0.110 logMAR Standard Deviation 0.0806
Monocular Contact Lens-corrected Distance Visual Acuity (Modified Intent-to-Treat Population) Visit 2 (1-week follow up)	-0.115 logMAR Standard Deviation 0.0717	-0.117 logMAR Standard Deviation 0.0815

SECONDARY outcome

Timeframe: Up to 1-Week Follow-up

Population: Modified intent-to-treat (MITT) which consists of all the subjects who were administered either study lens excluding subjects who drop out prior to administering any study article. MITT is identical to safety population.

Slit lamp findings were assessed using a biomicroscope for each subject eye at all scheduled and unscheduled visits. Clinical significant slit lamp findings are defined as Grade 3 or Grade 4. (Grade 0=None, Grade 1=Trace, Grade 2=Mild, Grade 3=Moderate and Grade 4= Severe). The data was dichotomized as 1=Grade 3 or Grade 4 and 0, otherwise. The number of eyes with clinically significant slit lamp findings for each lens type was reported.

Outcome measures

Outcome measures
Measure	Etafilcon A With Ketotifen n=188 eyes Subjects that wore the etafilcon A with ketotifen contact lens throughout the entire duration of the study.	Etafilcon A n=94 eyes Subjects that wore the etafilcon A contact lens throughout the entire duration of the study.
The Number of Eyes With Clinically Significant Slit Lamp Findings	0 Number of Eyes	0 Number of Eyes

SECONDARY outcome

Timeframe: Up to 1-Week Follow-up

Population: Modified intent-to-treat (MITT) which consists of all the subjects who were administered either study lens excluding subjects who drop out prior to administering any study article. MITT is identical to safety population.

Lens fit was assessed for each subject and eye using a biomicroscope. Unacceptable lens fit was assessed at all scheduled and unscheduled visits. A subject was deemed to have an unacceptable lens fitting if they met any of the following criteria: (1) Limbal exposure at primary gaze with extreme eye movement, (2) edge lift, (3) excessive movement in primary up gaze, (4) insufficient movement in all three of the following conditions: primary gaze, up gaze and push up test. The number of eyes with unacceptable lens fitting was reported for each lens type.

Outcome measures

Outcome measures
Measure	Etafilcon A With Ketotifen n=188 Number of Eyes Subjects that wore the etafilcon A with ketotifen contact lens throughout the entire duration of the study.	Etafilcon A n=94 Number of Eyes Subjects that wore the etafilcon A contact lens throughout the entire duration of the study.
The Number of Eyes With Unacceptable Lens Fitting	0 eyes	1 eyes

Adverse Events

Etafilcon A With Ketotifen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon 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 O.D, MS, FAAO

Johnson & Johnson Vision Care, Inc.

Phone: 1-800-843-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60