Lid Wiper Epitheliopathy Trial

NCT01870856 | Terminated Results

• 1 other identifier: C-13-005
• Study Type: interventional
• Target: 187
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lid Wiper Epitheliopathy

Keywords

Ocular discomfort; Contact lenses; Myopia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 2

Secondary Outcomes (1)

• Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks

  Baseline, Week 2

Study Arms (4)

Spectacles, Stage 1

EXPERIMENTAL

Spectacles per participant's habitual perscription worn for 2 weeks

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

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

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

Device: Etafilcon A contact lenses

Interventions

Spectacles DEVICE

Per participant's habitual prescription

Spectacles, Stage 1

Delefilcon A contact lenses DEVICE

Silicone hydrogel single vision contact lenses

Also known as: DAILIES TOTAL1®

DAILIES TOTAL1, Stage 2

Etafilcon A contact lenses DEVICE

Hydrogel single vision contact lenses

Also known as: 1-DAY ACUVUE®

1-DAY ACUVUE, Stage 1; 1-DAY ACUVUE, Stage 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Anne Brobst, Clinical Project Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Anne Brobst, OD, FAAO

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 29, 2014
• Results First Posted: October 29, 2014

Record last verified: 2014-10