Trial Outcomes & Findings for Effects of Multifocal Contact Lens on Ocular Tissue (NCT NCT02345720)

Results Overview

Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm\^2.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

30 days Post wear

Results posted on

2018-06-19

Participant Flow

A total of 23 subjects were enrolled in this study. Of the enrolled subjects, 3 did not meet the eligibility criteria and 20 were dispensed a study lens. All dispensed subjects completed the study.

Participant milestones

Participant milestones
Measure	Etafilcon PVP (Multi-focal) All subjects wore the same study lenses throughout the duration of this study.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Multifocal Contact Lens on Ocular Tissue

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etafilcon PVP (Multi-focal) n=20 Participants All subjects wore the same study lenses throughout the duration of this study.
Age, Continuous	50.6 Years STANDARD_DEVIATION 6.85 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	20 Participants n=5 Participants
Region of Enrollment United Kingdom	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days Post wear

Population: The analysis population consists of all subjects that were dispensed a study lens.

Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm\^2.

Outcome measures

Outcome measures
Measure	Etafilcon PVP (Multi-focal) n=20 Participants All subjects wore the same study lenses throughout the duration of this study.
Upper Eye Lid Margin Staining	1.96 mm^2 Standard Deviation 1.03

PRIMARY outcome

Timeframe: 30 Days Post Wear

Population: The analysis population consist of all subjects that were dispensed a study lens.

Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.

Outcome measures

Outcome measures
Measure	Etafilcon PVP (Multi-focal) n=20 Participants All subjects wore the same study lenses throughout the duration of this study.
Limbal Staining Nasal	1.03 percentage of limbal area Standard Deviation 1.30
Limbal Staining Temporal	0.68 percentage of limbal area Standard Deviation 1.38

PRIMARY outcome

Timeframe: 30 Days Post Wear

Population: The analysis population consists of all subjects that were dispensed a study lens.

The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.

Outcome measures

Outcome measures
Measure	Etafilcon PVP (Multi-focal) n=20 Participants All subjects wore the same study lenses throughout the duration of this study.
Corneal Staining	0.05 percentage of upper corneal quadrant Standard Deviation 0.12

Adverse Events

Etafilcon PVP (Multi-focal)

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

Tom Karkkainen, OD, MS, FAAO

Johnson & Johnson Vision Care Inc.

Phone: 904-443-3500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60