Trial Outcomes & Findings for A Non-dispensing Fit Evaluation of Investigational Limbal Ring Soft Contact Lenses With Polyvinylpyrrolidone (PVP) in Asian Eyes (NCT NCT02036320)

NCT ID: NCT02036320

Last Updated: 2018-06-19

Results Overview

The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 190 participants
• Primary outcome timeframe: 15 mins post insertion
• Results posted on: 2018-06-19

Participant Flow

206 subjects were enrolled in this study. 16 subjects did not meet the eligibility criteria. 190 subjects were dispensed lenses and, 177 subjects completed all study visits without a major protocol deviation. 13 subjects were recorded as having protocol violations. No subjects were discontinued during this study.

Participant milestones

Measure	Test 1/Test 2 Subjects who received test lens 1 first and then received test lens 2.	Test 2/Test 1 Subjects who received test lens 2 first and then received test lens 1.
Period 1 STARTED	95	95
Period 1 COMPLETED	95	95
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	95	95
Period 2 COMPLETED	95	95
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Non-dispensing Fit Evaluation of Investigational Limbal Ring Soft Contact Lenses With Polyvinylpyrrolidone (PVP) in Asian Eyes

Baseline characteristics by cohort

Measure	Overall n=190 Participants All subjects that were dispensed a test article during the study.
Age, Continuous	24.75 years STANDARD_DEVIATION 4.416 • n=93 Participants
Sex: Female, Male Female	190 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	190 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	161 participants n=93 Participants
Region of Enrollment Canada	29 participants n=93 Participants

PRIMARY outcome

Timeframe: 15 mins post insertion

Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.

The number of subject eyes that were classified as having acceptable mechanical lens fit, with a slit lamp.

Outcome measures

Measure	Test 1 n=354 Eyes Subjects that received Test lens 1 during the first or second period of the study.	Test 2 n=354 Eyes Subjects that received Test lens 2 during the first or second period of the study.
Mechanical Lens Fit Acceptance	345 Eyes	337 Eyes

PRIMARY outcome

Timeframe: 15 mins post insertion

Population: The analysis population consists of subjects that completed all study visits without a major protocol deviation.

The number of subject eyes that were classified as having acceptable cosmetic lens fit in primary gaze, without a slit lamp.

Outcome measures

Measure	Test 1 n=354 Eyes Subjects that received Test lens 1 during the first or second period of the study.	Test 2 n=354 Eyes Subjects that received Test lens 2 during the first or second period of the study.
Cosmetic Lens Fit Acceptance	349 Eyes	349 Eyes

PRIMARY outcome

Timeframe: 15 mins post insertion

Population: The analysis population consists of subjects that completed all study visits, without a major protocol deviation

The number of subjects that did not exhibit a "hula hoop" effect as recorded by Eye Care Practitioner (ECP) judgment of acceptable physiology, in primary gaze, without a slit lamp.

Outcome measures

Measure	Test 1 n=177 Participants Subjects that received Test lens 1 during the first or second period of the study.	Test 2 n=177 Participants Subjects that received Test lens 2 during the first or second period of the study.
Lens Does Not Exhibit "Hula Hoop" Effect	176 Subject	176 Subject

Adverse Events

Test 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test 2

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

Meredith Jansen,O.D.,M.S., FAAO

Johnson and Johnson Vision Care Inc.

Phone: 904-443-3500

Email: mjanse12@ITS.JNJ.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60