Trial Outcomes & Findings for Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses (NCT NCT02537522)

Last Updated: 2017-07-11

Results Overview

CLUE- The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ. Et al. August 2016). Keratometry measurements of major keratometric meridians (diopter \[DK\]) and their location (degrees) was collected at baseline for both eyes. The correlation between CLUE comfort and maximum Keratometry measurements of the two eyes within each subject and the correlation between CLUE comfort and the minimum Keratometry measurements of the two eyes within each subject were reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

72 participants

Primary outcome timeframe

3-day follow-up

Results posted on

2017-07-11

Participant Flow

A total of 72 subjects were enrolled into this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 71 were dispensed lenses. Of the dispensed subjects 45 completed both Phase I and II while 26 subjects were discontinued.

Participant milestones

Participant milestones
Measure	Test/Control - Phase 1 Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 8.5 Base Curve in their left eye and then wore the narafilcon A with 9.0 Base Curve in their right eye.	Control/Test - Phase 1 Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 9.0 Base Curve in their left eye and then wore the narafilcon A with 8.5 Base Curve in their right eye.	Test/Control - Phase 2 Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 8.5 Base Curve in both eyes and then wore narafilcon A lens with 9.0 Base Curve in both eyes.	Control/Test - Phase 2 Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 9.0 Base Curve in both eyes and then wore narafilcon A lens with 8.5 Base Curve in both eyes.
Phase I - Contralateral STARTED	34	37	0	0
Phase I - Contralateral COMPLETED	19	27	0	0
Phase I - Contralateral NOT COMPLETED	15	10	0	0
Phase II - Period 1 Bilateral STARTED	0	0	23	23
Phase II - Period 1 Bilateral COMPLETED	0	0	23	22
Phase II - Period 1 Bilateral NOT COMPLETED	0	0	0	1
Phase II - Period 2 Bilateral STARTED	0	0	23	22
Phase II - Period 2 Bilateral COMPLETED	0	0	23	22
Phase II - Period 2 Bilateral NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test/Control - Phase 1 Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 8.5 Base Curve in their left eye and then wore the narafilcon A with 9.0 Base Curve in their right eye.	Control/Test - Phase 1 Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 9.0 Base Curve in their left eye and then wore the narafilcon A with 8.5 Base Curve in their right eye.	Control/Test - Phase 2 Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 9.0 Base Curve in both eyes and then wore narafilcon A lens with 8.5 Base Curve in both eyes.
Phase I - Contralateral Subject no longer eligible	15	7	0
Phase I - Contralateral Withdrawal by Subject	0	1	0
Phase I - Contralateral incorrect randomization	0	1	0
Phase I - Contralateral unsatisfactory lens fitting	0	1	0
Phase II - Period 1 Bilateral Adverse Event	0	0	1

Baseline Characteristics

Evaluation of 8.5 vs 9.0 Base Curve for 1-DAY ACUVUE(r) TruEye(r) Brand Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=71 Participants All subjects that were dispensed at least one study lens throughout the course of the study.
Age, Continuous	28.7 years STANDARD_DEVIATION 6.24 • n=99 Participants
Sex: Female, Male Female	43 Participants n=99 Participants
Sex: Female, Male Male	28 Participants n=99 Participants
Region of Enrollment United States	71 participants n=99 Participants

PRIMARY outcome

Timeframe: 3-day follow-up

Population: Subjects that completed all study visits without a major protocol deviation.

Outcome measures

Outcome measures
Measure	Narafilcon A- 8.5 Base Curve n=43 Participants Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.	Narafilcon A- 9.0 Base Curve n=43 Participants Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
Correlation Between Subjective CLUE Comfort and Keratometry Minimum Keratometry measurements	0.042 Pearson Correlation	0.004 Pearson Correlation
Correlation Between Subjective CLUE Comfort and Keratometry Maximum Keratometry measurements	-0.001 Pearson Correlation	-0.002 Pearson Correlation

PRIMARY outcome

Timeframe: 3-day follow-up

Population: Subjects that completed all study visits without a major protocol deviation.

Assessment The Contact Lens User Evaluation (CLUE)™ questionnaire is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20) with a range of 0-120, where higher scores indicate a more favorable/positive response (Wirth, RJ Et al. August 2016). Corneal diameter (horizontal visible iris diameter \[HVID\]) was collected at baseline for both eyes using a slit lamp reticle, measuring to the nearest 0.05 mm.The maximum (or minimum) measurements of HVID between the two eyes of each subject were used for correlation analyses between subjective CLUE comfort score and corneal diameter.

Outcome measures

Outcome measures
Measure	Narafilcon A- 8.5 Base Curve n=43 Participants Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase II.	Narafilcon A- 9.0 Base Curve n=43 Participants Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase II.
Correlation Between Subjective CLUE Comfort and Corneal Diameter Minimum Corneal diameter	0.011 Pearson Correlation	-0.086 Pearson Correlation
Correlation Between Subjective CLUE Comfort and Corneal Diameter Maximum Corneal diameter	0.021 Pearson Correlation	-0.119 Pearson Correlation

Adverse Events

Narafilcon A- 8.5 Base Curve

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Narafilcon A- 9.0 Base Curve

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

Andrea Le, OD -Manager Global Medical Affairs

Johnson & Johnson Vision Care Inc.

Phone: 904 4431866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60