Trials Sponsors Conditions Drugs Pricing

Conditions

Lid Wiper Epitheliopathy

Keywords

Lid Wiper EpitheliopahtyCoefficient of Friction

Outcome Measures

Primary Outcomes (1)

Lid Wiper Epitheliopathy
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.
One week post contact lens fitting

Secondary Outcomes (1)

Lid Wiper Epitheliopathy
2 hours post contact lens fitting

Study Arms (2)

Eye 1: Low coefficient of friction

OTHER

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.

Device: Acuvue Oasys

Eye 2: High coefficient of friction

OTHER

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

Device: Air Optix Night & Day Aqua

Interventions

Acuvue OasysDevice

FDA approved contact lens, fit for daily wear

Eye 1: Low coefficient of friction

Air Optix Night & Day AquaDevice

FDA approved contact lens, fit for daily wear

Eye 2: High coefficient of friction

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 46 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Must be able to read and understand the study informed consent
Must be a minimum of 18 years of age and less than 46 years of age at study enrollment

Sponsors & Collaborators

University of Houston
Otherlead

Study Sites (1)

The Ocular Surface Institute, The University of Houston College of Optometry

Houston, Texas, 77204, United States

Results Point of Contact

Title: Eric Ritchey, OD, PhD
Organization: University of Houston College of Optometry

Study Officials

Eric R Ritchey, OD, PhD
University of Houston
PRINCIPAL INVESTIGATOR
Rachel Redfern, OD, PhD
University of Houston
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes
Restrictive Agreement: No

Enrollment

20 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Masking Details: Subjects will be masked to the contact lens brand fit in each eye. The subject's Lid Wiper Epitheliopathy will be graded using photographs of the eyelid, where the grader is masked to the lens type in each eye.
Purpose: BASIC SCIENCE
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

June 30, 2017

First Posted

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Eye 1: Low coefficient of friction

Eye 2: High coefficient of friction

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Eye 1: Low coefficient of friction

Eye 2: High coefficient of friction

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations