Lid Wiper EpitheliopathyPhase 4NCT03209505
The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)
A Phase 4 study testing Acuvue Oasys and Air Optix Night & Day Aqua in people with Lid Wiper Epitheliopathy, run by University of Houston at 1 site in United States.
Trial summary
This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with contact lenses having difference coefficients of friction (CoF) Read more about this study
- Who is it for?
- Ages 18 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Lid Wiper Epitheliopathy
- What is being tested?
- Acuvue Oasys and Air Optix Night & Day Aqua
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 13 Apr 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 46 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Must be healthy non-soft contact lens wearers (neophytes), or experienced contact lens wearers that have not worn their contact lenses for a minimum of 7 days
- Have a spherical equivalent refractive error between -0.75 to -6.50DS at the spectacle plane
- The subject must be able to attend study visits at the prescribed visit times and adhere to the study instructions
Who cannot join
- Pregnant and/or lactating females by self-report
- Presence of current LWE on the upper eyelid (>0.5 in height or width)
- Has greater than -1.00DC of refractive cylinder
- Has greater than 1.00D of anisometropia
- Is aphakic
- Has clinically significant corneal or conjunctival staining that would prevent contact lens fitting, as assessed with sodium fluorescein dye
Show all 14Show fewer
- Has significant ocular surface disease (e.g. Sjögrens Disease, Stevens-Johnson Syndrome, etc.) or significant Dry Eye Syndrome
- Has clinically significant corneal vascularization or central corneal scaring
- Has active ocular surface infection (e.g. conjunctivitis)
- Has a positive history of eyelid surgery or trauma
- Has a positive history of refractive surgery
- Takes medications that significantly impact contact lens comfort and/or ocular surface health
- Has taken part in another contact lens or contact lens solution clinical trial within the last 7 days
- Is unwilling to have eyes photographed or video recorded
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ocular Surface Institute, The University of Houston College of Optometry
Houston, Texas, 77204
About this study
This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with contact lenses having difference coefficients of friction (CoF)
Read the detailed description
The primary study objectives are to determine the amount of Lid Wiper Epitheliopathy (LWE) induced in subjects after contact lens fitting that do not have LWE at study enrollment. Subjects in the trial will be fit in 2 contact lenses with different coefficients of friction (CoF). One eye will be fit in a contact lens with a low coefficient of friction (Acuvue Oasys®, Johnson \& Johnson Vision, Jacksonville FL) while the contralateral eye will be fit in a contact lens with a high CoF (Air Optix® Night \& Day® Aqua, Ft. Worth, TX), as reported in the scientific literature. The eye receiving each lens will be assigned randomly. The presence of LWE will be assessed at 2 different time points, approximately 2 hours after contact lens fitting and approximately after 7 days of contact lens wear.
- Conditions
- Lid Wiper Epitheliopathy
- Being tested
- Acuvue Oasys, Air Optix Night & Day Aqua
- Keywords
- Lid Wiper Epitheliopahty, Coefficient of Friction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuvue OasysDevice
FDA approved contact lens, fit for daily wear
Air Optix Night & Day AquaDevice
FDA approved contact lens, fit for daily wear
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Air Optix Night & Day Aqua |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week post contact lens fitting
Secondary 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.
Measured: 2 hours post contact lens fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start26 Jun 2017
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lid Wiper EpitheliopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. One eye will be fit in a contact lens with a low coefficient of friction while the contralateral eye will be fit in a contact lens with a high coefficient of friction.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric R. Ritchey, University of Houston
- Investigators
- Eric R Ritchey, OD, PhD, Principal investigator, University of HoustonRachel Redfern, OD, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209505
- Sponsor's protocol ID
- STUDY00000386
- Status last verified
- Aug 2021
- First submitted
- 30 Jun 2017
- Last updated
- 31 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)
- ClinicalTrials.gov ID
- NCT03209505
- Acronym / sponsor ID
- STUDY00000386
- Conditions
- Lid Wiper Epitheliopathy
- Keywords
- Lid Wiper Epitheliopahty, Coefficient of Friction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Posted 31 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with contact lenses having difference coefficients of friction (CoF)
Detailed description
The primary study objectives are to determine the amount of Lid Wiper Epitheliopathy (LWE) induced in subjects after contact lens fitting that do not have LWE at study enrollment. Subjects in the trial will be fit in 2 contact lenses with different coefficients of friction (CoF). One eye will be fit in a contact lens with a low coefficient of friction (Acuvue Oasys®, Johnson \& Johnson Vision, Jacksonville FL) while the contralateral eye will be fit in a contact lens with a high CoF (Air Optix® Night \& Day® Aqua, Ft. Worth, TX), as reported in the scientific literature. The eye receiving each lens will be assigned randomly. The presence of LWE will be assessed at 2 different time points, approximately 2 hours after contact lens fitting and approximately after 7 days of contact lens wear.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. One eye will be fit in a contact lens with a low coefficient of friction while the contralateral eye will be fit in a contact lens with a high coefficient of friction.
| Arm | Type | Receives |
|---|---|---|
| Eye 1: Low coefficient of friction | Other | Device: Acuvue OasysSubjects 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. |
| Eye 2: High coefficient of friction | Other | Device: Air Optix Night & Day AquaSubjects 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 |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- Must be healthy non-soft contact lens wearers (neophytes), or experienced contact lens wearers that have not worn their contact lenses for a minimum of 7 days
- Have a spherical equivalent refractive error between -0.75 to -6.50DS at the spectacle plane
- The subject must be able to attend study visits at the prescribed visit times and adhere to the study instructions
Key exclusion criteria (14 listed)
- Pregnant and/or lactating females by self-report
- Presence of current LWE on the upper eyelid (>0.5 in height or width)
- Has greater than -1.00DC of refractive cylinder
- Has greater than 1.00D of anisometropia
- Is aphakic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acuvue OasysFDA approved contact lens, fit for daily wear | Device | Eye 1: Low coefficient of friction |
| Air Optix Night & Day AquaFDA approved contact lens, fit for daily wear | Device | Eye 2: High coefficient of friction |
Primary outcome
Lid Wiper Epitheliopathy
Time frame: 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.
1 secondary outcome
Lid Wiper Epitheliopathy
Time frame: 2 hours post contact lens fitting
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric R Ritchey, OD, PhD principal investigator
University of Houston
Rachel Redfern, OD, PhD principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acuvue Oasys and Air Optix Night & Day Aqua in people with Lid Wiper Epitheliopathy, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lid Wiper Epitheliopathy (time frame: One week post contact lens fitting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.