Trial Outcomes & Findings for Corneal Staining Associated With Daily Disposable Beauty Contact Lenses (NCT NCT01882465)

Last Updated: 2018-06-19

Results Overview

Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) using Sodium Fluorescein strips. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The total was calculated by using the sum across all regions by time point. The range for the total grade for each time point would be 0-20. The total average grade for each lens and time point was evaluated as an average change from baseline level of corneal staining.

Recruitment status

TERMINATED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

20 minutes and 7 hours post lens fitting

Results posted on

2018-06-19

Participant Flow

A total of 35 subjects were enrolled in this study. Of the enrolled 1 subject did not meet the eligibility criteria.

Of the remaining 34 subjects, 1 subjects withdrew consent before randomization and was discontinued from the study. A total of 33 subjects were dispensed a study lens. Of the dispensed subjects 2 were discontinued and 31 completed the study. A total of 3 subjects were discontinued from this study.

Participant milestones

Participant milestones
Measure	Etafilcon A/2-HEMA, EGDMA/Hefilcon A Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.	Etafilcon A/Hefilcon A/2-HEMA, EGDMA Non-ionic Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the hefilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.	2-HEMA, EGDMA Non-ionic/Etafilcon A/Hefilcon A Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the etafilcon A lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.	2-HEMA, EGDMA Non-ionic/Hefilcon A/Etafilcon A Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.	Hefilcon A/2-HEMA, EGDMA Non-ionic/Etafilcon A Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.	Hefilcon A/Etafilcon A /2-HEMA, EGDMA Non-ionic Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the etafilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.	Not Assigned Subjects that signed the inform consent, but them withdrew consent, prior to lens dispensing.
Period 1 STARTED	6	6	5	6	5	5	1
Period 1 COMPLETED	6	6	5	5	5	5	0
Period 1 NOT COMPLETED	0	0	0	1	0	0	1
Period 2 STARTED	6	6	5	5	5	5	0
Period 2 COMPLETED	6	6	5	5	4	5	0
Period 2 NOT COMPLETED	0	0	0	0	1	0	0
Period 3 STARTED	6	6	5	5	4	5	0
Period 3 COMPLETED	6	6	5	5	4	5	0
Period 3 NOT COMPLETED	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	2-HEMA, EGDMA Non-ionic/Hefilcon A/Etafilcon A Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.	Hefilcon A/2-HEMA, EGDMA Non-ionic/Etafilcon A Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.	Not Assigned Subjects that signed the inform consent, but them withdrew consent, prior to lens dispensing.
Period 1 Lens Discomfort	1	0	0
Period 1 Withdrawal by Subject	0	0	1
Period 2 Protocol Violation	0	1	0

Baseline Characteristics

Corneal Staining Associated With Daily Disposable Beauty Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=35 Participants All subjects that were enrolled into the study.
Age, Continuous	22.03 Years STANDARD_DEVIATION 2.885 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian	35 Participants n=5 Participants
Region of Enrollment Hong Kong	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: 20 minutes and 7 hours post lens fitting

Population: All subjects that completed every study visit without a major protocol deviation.

Outcome measures

Outcome measures
Measure	Etafilcon A n=62 Subject Eyes Subjects that received the etafilcon A lens in any of the three study periods.	2-HEMA, EGDMA Non-ionic n=62 Subject Eyes Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods.	Hefilcon A n=64 Subject Eyes Subjects that received the hefilcon A lens in any of the three study periods.
Corneal Staining Baseline: 20 Minutes	0.26 units on a scale Standard Deviation 0.569	0.15 units on a scale Standard Deviation 0.580	0.29 units on a scale Standard Deviation 0.624
Corneal Staining 7 Hours Post Lens Fitting	-0.04 units on a scale Standard Deviation 1.154	0.49 units on a scale Standard Deviation 1.090	-0.02 units on a scale Standard Deviation 1.233

Adverse Events

Etafilcon A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2-HEMA, EGDMA Non-ionic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hefilcon 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

Charis Lau, PharmD, OD, FAAO- Principal Research Optometrist

Johnson & Johnson Vision Care Inc.

Phone: 904-433-3500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60