Trial Outcomes & Findings for Investigational Multi-purpose Contact Lens Care Solution. (NCT NCT01055613)

Last Updated: 2018-06-19

Results Overview

Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The number of eyes with Grade 3 or higher for each lens was reported for each assessment.

Recruitment status

COMPLETED

Study phase

Target enrollment

312 participants

Primary outcome timeframe

3 months

Results posted on

2018-06-19

Participant Flow

A total of 312 subjects were enrolled in this study. Of the enrolled subjects 12 did not meet the eligibility criteria and 300 were randomized to treatment using an allocation of 2:1 for test and control, respectively. Of the 300 randomized subjects 13 were discontinued from the study and 287 subjects completed the study.

Participant milestones

Participant milestones
Measure	Experimental Multi-purpose Solution Experimental multi-purpose contact lens care solution (Test treatment)	ReNu MultiPlus Multi-Purpose Solution Marketed multi-purpose contact lens care solution (Control Treatment).
Overall Study STARTED	200	100
Overall Study COMPLETED	191	96
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Multi-purpose Solution Experimental multi-purpose contact lens care solution (Test treatment)	ReNu MultiPlus Multi-Purpose Solution Marketed multi-purpose contact lens care solution (Control Treatment).
Overall Study No Longer Meets Eligibility Criteria	3	0
Overall Study Unacceptable lens fit	1	0
Overall Study Discomfort	2	1
Overall Study Lost to Follow-up	1	1
Overall Study Protocol Violation	1	1
Overall Study Subject Disinterest	1	1

Baseline Characteristics

Investigational Multi-purpose Contact Lens Care Solution.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Mutli-purpose Solution n=200 Participants Experimental multi-purpose solution (Test treatment) .	ReNu Multi-purpose Solution n=100 Participants Marketed multi-purpose solution (Control Treatment).	Total n=300 Participants Total of all reporting groups
Age, Continuous	32.40 years STANDARD_DEVIATION 9.231 • n=5 Participants	31.05 years STANDARD_DEVIATION 8.624 • n=7 Participants	31.73 years STANDARD_DEVIATION 8.928 • n=5 Participants
Sex: Female, Male Female	145 Participants n=5 Participants	71 Participants n=7 Participants	216 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	29 Participants n=7 Participants	84 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Island Pacificer	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized White	185 participants n=5 Participants	88 participants n=7 Participants	273 participants n=5 Participants
Race/Ethnicity, Customized Other	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Native Alaskian	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	200 participants n=5 Participants	100 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The analysis population consists of all subjects that were dispensed a solution during the course of the study.

Outcome measures

Outcome measures
Measure	Experimental Multi-purpose Solution n=382 Subject Eye's Experimental multi-purpose contact lens care solution (Test treatment)	ReNu MultiPlus Multi-Purpose Solution n=192 Subject Eye's Marketed multi-purpose contact lens care solution (Control Treatment).
Slit Lamp Findings Tarsal Abnormalities	14 Subjects Eyes	12 Subjects Eyes
Slit Lamp Findings Corneal Staining	11 Subjects Eyes	16 Subjects Eyes
Slit Lamp Findings Conjunctival Staining	0 Subjects Eyes	0 Subjects Eyes

PRIMARY outcome

Timeframe: Up to 3 Months

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

Distance visual acuity was collected at the 1-, 2-, 3-week and 1- and 3- month follow-up evaluations. The average LogMAR across all visits for each lens type was reported.

Outcome measures

Outcome measures
Measure	Experimental Multi-purpose Solution n=382 Subject Eyes Experimental multi-purpose contact lens care solution (Test treatment)	ReNu MultiPlus Multi-Purpose Solution n=192 Subject Eyes Marketed multi-purpose contact lens care solution (Control Treatment).
Distance Visual Acuity (LogMAR)	-0.030 LogMAR Standard Deviation 0.0639	-0.031 LogMAR Standard Deviation 0.0634

Adverse Events

Experimental Multi-purpose Solution

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

ReNu MultiPlus Multi-Purpose Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental Multi-purpose Solution n=200 participants at risk Experimental multi-purpose contact lens care solution (Test treatment)	ReNu MultiPlus Multi-Purpose Solution n=100 participants at risk Marketed multi-purpose contact lens care solution (Control Treatment).
Eye disorders Microbial Keratitis	0.50% 1/200 • Number of events 1 • Throughout the duration of the study. Approximately 3 months.	0.00% 0/100 • Throughout the duration of the study. Approximately 3 months.

Other adverse events

Adverse event data not reported

Additional Information

Brian Pall, O.D.- Research Principle Optometrist

Johnson & Johnson Vision Care Inc.

Phone: 904-443-1290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60