Lid Wiper Epitheliopathy Trial

This study has been terminated.
(Stage 1 failed to show a difference in LWE reduction.)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01870856
First received: June 4, 2013
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy in symptomatic contact lens wearers. Lid wiper epitheliopathy is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.


Condition Intervention
Lid Wiper Epitheliopathy
Device: Spectacles
Device: Delefilcon A contact lenses
Device: Etafilcon A contact lenses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Lid Wiper Epitheliopathy With and Without Daily Disposable Contact Lenses

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Stage 1: Percent of eyes experiencing at least 1 grade reduction in lid wiper epitheliopathy at 2 weeks [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
    Lid wiper epitheliopathy (LWE) will be measured by slit lamp evaluation of fluorescein and lissamine green staining to the tissue that lines the margin of the inside of the upper eyelid. LWE will be 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 will be compared between groups.

  • Stage 2: Percent of eyes experiencing at least 1 grade reduction in lid wiper epitheliopathy at 2 weeks [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
    Lid wiper epitheliopathy (LWE) will be measured by slit lamp evaluation of fluorescein and lissamine green staining to the tissue that lines the margin of the inside of the upper eyelid. LWE will be 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 will be compared between groups.


Secondary Outcome Measures:
  • Stage 2: Change in ocular discomfort score (as measured by SPEED) from baseline to 2 weeks [ Time Frame: Baseline (Day 0), Week 2 ] [ Designated as safety issue: No ]
    The SPEED questionnaire contains frequency (scale 0 to 3) and severity (scale 0 to 3) reported for the following four symptoms: dryness, grittiness/scratchiness, soreness/ irritation, and burning/watering. The SPEED score is derived as the summation over both the frequency and severity of all four symptoms, with resultant overall value 0 to 24, where 0=no ocular discomfort and 24=maximum ocular discomfort. Since the questionnaire is collected binocularly, the concept of study eye is not relevant.


Enrollment: 52
Study Start Date: July 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spectacles, Stage 1
Spectacles per participant's habitual perscription worn for two weeks
Device: Spectacles
Per participant's habitual prescription
Active Comparator: 1-DAY ACUVUE, Stage 1
Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for two weeks in a daily disposable mode
Device: Etafilcon A contact lenses
Hydrogel single vision contact lenses
Other Name: 1-DAY ACUVUE®
Experimental: DAILIES TOTAL1, Stage 2
Delefilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for two weeks in a daily disposable mode
Device: Delefilcon A contact lenses
Silicone hydrogel single vision contact lenses
Other Name: DAILIES TOTAL1®
Active Comparator: 1-DAY ACUVUE, Stage 2
Etafilcon A contact lenses worn in both eyes at least 5 days per week, at least 6 hours per day, for two weeks in a daily disposable mode
Device: Etafilcon A contact lenses
Hydrogel single vision contact lenses
Other Name: 1-DAY ACUVUE®

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 lid wiper epitheliopathy. In Stage 2, a second cohort of participants will wear one of two contact lens brands for two weeks, and lid wiper epitheliopathy and ocular discomfort will be compared.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 with best corrected distance visual acuity greater than or equal to 20/25 in each eye.
  • Astigmatism less than or equal to 0.75 diopter.
  • 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.

Exclusion Criteria:

  • Eye injury within twelve 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870856

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Anne Brobst, OD, FAAO Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01870856     History of Changes
Other Study ID Numbers: C-13-005
Study First Received: June 4, 2013
Last Updated: January 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Ocular discomfort
Contact lenses
Myopia

ClinicalTrials.gov processed this record on July 24, 2014