Lid Wiper EpitheliopathyNCT01870856
Lid Wiper Epitheliopathy Trial
A study testing Spectacles, Delefilcon A contact lenses and Etafilcon A contact lenses in people with Lid Wiper Epitheliopathy, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lid Wiper Epitheliopathy
- What is being tested?
- Spectacles, Delefilcon A contact lenses and Etafilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Oct 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign Informed Consent document.
- Severe lid wiper epitheliopathy (upper lid) in either eye.
- Currently wearing spherical daily disposable soft contact lenses or daily wear soft contact lenses in both eyes with at least 3 months of contact lens wearing experience.
- Symptomatic as determined by the SPEED questionnaire.
- Willing to follow visit schedule.
- Habitual contact lens power with the range of -1.00 to -6.00 diopters (D) with best corrected distance visual acuity greater than or equal to 20/25 in each eye.
Show all 10Show fewer
- Astigmatism less than or equal to 0.75D.
- Possess spectacles which provide visual acuity of at least 20/25 in each eye.
- Willing and able to complete daily diaries.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Eye injury within 12 weeks immediately prior to enrollment.
- Any ocular condition that would contraindicate contact lens wear.
- Any use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator.
- Currently wearing toric or multifocal soft contact lenses.
- Participation in a clinical study (including contact lens or contact lens care product) within the previous 30 days.
- Routinely sleeps in lenses for at least 1 night per week.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Evaluation of Lid Wiper Epitheliopathy With and Without Daily Disposable Contact Lenses
The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.
Read the detailed description
This study will be conducted in two stages. In Stage 1, participants will wear either spectacles or contact lenses for two weeks to determine the impact of interruption of contact lens wear on LWE. In Stage 2, a second cohort of participants will wear one of two contact lens brands for two weeks, and LWE and ocular discomfort will be compared.
- Conditions
- Lid Wiper Epitheliopathy
- Being tested
- Spectacles, Delefilcon A contact lenses, Etafilcon A contact lenses
- Keywords
- Ocular discomfort, Contact lenses, Myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpectaclesDevice
Per participant's habitual prescription
Delefilcon A contact lensesDevice
Also called DAILIES TOTAL1®
Silicone hydrogel single vision contact lenses
Etafilcon A contact lensesDevice
Also called 1-DAY ACUVUE®
Hydrogel single vision contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Spectacles, Stage 1 | Experimental | Spectacles per participant's habitual perscription worn for 2 weeks Receives: Device: Spectacles |
| 1-DAY ACUVUE, Stage 1 | Active comparator | Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode Receives: Device: Etafilcon A contact lenses |
| DAILIES TOTAL1, Stage 2 | Experimental | Delefilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode Receives: Device: Delefilcon A contact lenses |
| 1-DAY ACUVUE, Stage 2 | Active comparator | Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode Receives: Device: Etafilcon A contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.
Measured: Baseline, Week 2
Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
This outcome measure was not evaluated since primary efficacy was not demonstrated.
Measured: Baseline, Week 2
Secondary outcomes (1)
Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks
This outcome measure was not evaluated since primary efficacy was not demonstrated.
Measured: Baseline, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: Primary efficacy was not demonstrated in Stage 1
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Brobst, OD, FAAO, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870856
- Sponsor's protocol ID
- C-13-005
- Status last verified
- Oct 2014
- First submitted
- 4 Jun 2013
- Last updated
- 29 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lid Wiper Epitheliopathy With and Without Daily Disposable Contact Lenses
- ClinicalTrials.gov ID
- NCT01870856
- Acronym / sponsor ID
- C-13-005
- Conditions
- Lid Wiper Epitheliopathy
- Keywords
- Ocular discomfort, Contact lenses, Myopia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary efficacy was not demonstrated in Stage 1
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Posted 29 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.
Detailed description
This study will be conducted in two stages. In Stage 1, participants will wear either spectacles or contact lenses for two weeks to determine the impact of interruption of contact lens wear on LWE. In Stage 2, a second cohort of participants will wear one of two contact lens brands for two weeks, and LWE and ocular discomfort will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Spectacles, Stage 1 | Experimental | Device: SpectaclesSpectacles per participant's habitual perscription worn for 2 weeks |
| 1-DAY ACUVUE, Stage 1 | Active comparator | Device: Etafilcon A contact lensesEtafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode |
| DAILIES TOTAL1, Stage 2 | Experimental | Device: Delefilcon A contact lensesDelefilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode |
| 1-DAY ACUVUE, Stage 2 | Active comparator | Device: Etafilcon A contact lensesEtafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sign Informed Consent document.
- Severe lid wiper epitheliopathy (upper lid) in either eye.
- Currently wearing spherical daily disposable soft contact lenses or daily wear soft contact lenses in both eyes with at least 3 months of contact lens wearing experience.
- Symptomatic as determined by the SPEED questionnaire.
- Willing to follow visit schedule.
Key exclusion criteria (7 listed)
- Eye injury within 12 weeks immediately prior to enrollment.
- Any ocular condition that would contraindicate contact lens wear.
- Any use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator.
- Currently wearing toric or multifocal soft contact lenses.
- Participation in a clinical study (including contact lens or contact lens care product) within the previous 30 days.
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 |
|---|---|---|
| SpectaclesPer participant's habitual prescription | Device | Spectacles, Stage 1 |
| Delefilcon A contact lensesAlso: DAILIES TOTAL1®Silicone hydrogel single vision contact lenses | Device | DAILIES TOTAL1, Stage 2 |
| Etafilcon A contact lensesAlso: 1-DAY ACUVUE®Hydrogel single vision contact lenses | Device | 1-DAY ACUVUE, Stage 1, 1-DAY ACUVUE, Stage 2 |
Primary outcome
Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
Time frame: Baseline, Week 2
LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.
Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
Time frame: Baseline, Week 2
This outcome measure was not evaluated since primary efficacy was not demonstrated.
1 secondary outcome
Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks
Time frame: Baseline, Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Anne Brobst, OD, FAAO study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing Spectacles, Delefilcon A contact lenses and Etafilcon A contact lenses in people with Lid Wiper Epitheliopathy, run by Alcon Research.
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 10 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2014). 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?
Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks (time frame: Baseline, Week 2). The study lists 2 primary outcomes in all. 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 29 Oct 2014.