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Trial Outcomes & Findings for The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) (NCT NCT03209505)

NCT ID: NCT03209505

Last Updated: 2021-08-31

Results Overview

Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

One week post contact lens fitting

Results posted on

2021-08-31

Participant Flow

The study was a contralateral fitting study with one eye receiving the Acuvue Oasys and the contralateral eye receiving the Air Optix Night and Day. Forty eyes of twenty subjects were examined and completed the study

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure
Eye 1: Low Coefficient of Friction
Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 1 will be fit in a contact lens with a low coefficient of friction, Acuvue Oasys. Acuvue Oasys: FDA approved contact lens, fit for daily wear
Eye 2: High Coefficient of Friction
Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 2 One eye will be fit in a contact lens with a high coefficient of friction, Air Optix Night \& Day Aqua Air Optix Night \& Day Aqua: FDA approved contact lens, fit for daily wear
Overall Study
STARTED
10 20
10 20
Overall Study
COMPLETED
10 20
10 20
Overall Study
NOT COMPLETED
0 0
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Contact Lenses
n=20 Participants
Forty (40) eyes of twenty subjects were examined. One eye of each subject was assigned either the low coefficient of friction lens and the other eye received the high coefficient of friction lens. Lens/eye assignment occurred per the study randomization schedule.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
23.95 years
STANDARD_DEVIATION 2.31 • n=5 Participants
Sex: Female, Male
Female
15 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
14 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants
Refractive Error: Right Eye
-2.19 Diopters
STANDARD_DEVIATION 1.46 • n=5 Participants
Refractive Error: Left Eye
-1.94 Diopters
STANDARD_DEVIATION 1.75 • n=5 Participants

PRIMARY outcome

Timeframe: One week post contact lens fitting

Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy.

Outcome measures

Outcome measures
Measure
Eye 1: Low Coefficient of Friction
n=20 Eyes
Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 1 will be fit in a contact lens with a low coefficient of friction, Acuvue Oasys. Acuvue Oasys: FDA approved contact lens, fit for daily wear
Eye 2: High Coefficient of Friction
n=20 Eyes
Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 2 One eye will be fit in a contact lens with a high coefficient of friction, Air Optix Night \& Day Aqua Air Optix Night \& Day Aqua: FDA approved contact lens, fit for daily wear
Lid Wiper Epitheliopathy
0.63 score on a scale
Interval 0.0 to 1.44
0.25 score on a scale
Interval 0.0 to 1.94

SECONDARY outcome

Timeframe: 2 hours post contact lens fitting

Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy.

Outcome measures

Outcome measures
Measure
Eye 1: Low Coefficient of Friction
n=20 Eyes
Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 1 will be fit in a contact lens with a low coefficient of friction, Acuvue Oasys. Acuvue Oasys: FDA approved contact lens, fit for daily wear
Eye 2: High Coefficient of Friction
n=20 Eyes
Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 2 One eye will be fit in a contact lens with a high coefficient of friction, Air Optix Night \& Day Aqua Air Optix Night \& Day Aqua: FDA approved contact lens, fit for daily wear
Lid Wiper Epitheliopathy
0.75 score on a scale
Interval 0.0 to 1.75
0.13 score on a scale
Interval 0.0 to 1.44

Adverse Events

Eye 1: Low Coefficient of Friction

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Eye 2: High Coefficient of Friction

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

Eric Ritchey, OD, PhD

University of Houston College of Optometry

Phone: 713-743-1933

Results disclosure agreements

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