Investigating iLux Efficacy in Contact Lens Wearers With Evaporative Dry Eye Disease

NCT04159935 | Terminated Phase 4 Results FDA Device

• 1 other identifier: 41401
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to investigate the efficacy of a single iLux® treatment in symptomatic CL wearers who have DED (according to the TFOS DEWS II diagnostic criteria), of the evaporative dry eye disease subtype (EDE).

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Mean Change in the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From Baseline to 1 Month

  The mean change in dry eye symptoms from baseline based on the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire score was evaluated 1 month after iLux treatment. The SPEED questionnaire is a dry eye questionnaire developed to assess the frequency (0-3 scale, with higher values indicating more frequent symptoms) and severity (0-4 scale, with higher values indicating more severe symptoms) of patient symptoms. Scores range from 0-28. A higher SPEED score represents more frequent and/or more severe symptoms.

  1 month

Secondary Outcomes (12)

• Meibomian Gland Score at Baseline

  Baseline

• Meibomian Gland Score at 1 Month

  1 Month

• Meibomian Gland Score at 3 Months

  3 Months

• Comfortable Contact Lens Wear Time at Baseline

  Baseline

• Comfortable Contact Lens Wear Time at 1 Month

  1 Month

Study Arms (2)

iLux® treatment

EXPERIMENTAL

The treatment group will receive iLux® treatment at Visit 1 and will be reviewed 1- and 3-months after iLux® treatment.

Device: iLux® system

Delayed iLux® treatment

EXPERIMENTAL

Delayed iLux® treatment provided after 1 month (i.e. 1 month of no treatment, administer treatment after 1 month). Review 1- and 3-months after iLux® treatment.

Device: iLux® system

Interventions

iLux® system DEVICE

Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.

Delayed iLux® treatment; iLux® treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 18 years of age and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Has been using the same CL type (brand, material and dimensions) for \> 3 months;
• Wears commercially available soft CLs on average \>2 hours per day, 4-7 days per week;
• Is willing to try to wear their habitual CLs on average ≥ 6 hours per day, 4-7 days per week and maintain this for the duration of their involvement in the study;
• Demonstrates an acceptable lens fit of their habitual contact lenses;
• Does not have contact lens discomfort due to contact lens fit, lens material or known solution compatibility issues, in the opinion of the investigator;
• Has at least one month supply of their habitual contact lens products at the time of the screening visit;
• Has a CLDEQ-8 score ≥ 12;
• Has dry eye symptoms without CL wear (OSDI ≥ 13) and has at least one of the two following signs:
• Non-invasive tear break-up time (NITBUT) of \< 10 seconds in at least one eye;
• Fluorescein staining: \> 5 spots of corneal staining OR \> 9 conjunctival spots OR lid wiper staining (≥ 2mm length, ≥ 25% width) in at least one eye;
• Has a lipid layer thickness of ≤ 100 nm in both eyes;
• A meibomian gland secretion score (MGS) of ≤ 15 for 15 glands of the lower lid in both eyes.

You may not qualify if:

• Is participating in any concurrent clinical or research study;
• Has used any prescription systemic medications or topical treatments for MGD or dry eye for the past 30 days prior to the screening visit and not willing to stop using these for the study duration (excluding over-the-counter artificial tears, dietary supplements and ocular lubricants but includes warm compresses, eyelid massage, eyelid hygiene, manual meibomian gland expression, punctal plug insertion or punctal occlusion, intense pulsed light treatment of the face or eyelids);
• Has previously received treatment with an eyelid thermal pulsation device;
• Has a history of any of the following ocular (eye or eyelid) conditions or procedures in either eye within the past 90 days prior to the screening visit:
• Ocular trauma
• Chemical burns
• Ocular Herpes simplex or Herpes zoster infection
• Limbal stem cell deficiency
• Recurrent ocular inflammation (e.g. uveitis, iritis, scleritis, episcleritis, keratitis)
• Has undergone ocular surgery (e.g. intraocular, oculoplastic, corneal or refractive surgery procedure) within the past 12 months prior to the screening visit;
• Has permanent make-up or tattoos on their eyelids;
• Has any other known active\* ocular disease and/or infection in either eye including: cicatricial lid margin disease or severe (≥ grade 3) blepharitis; moderate to severe (grade 2-4) allergic, vernal or giant papillary conjunctivitis; a hordeolum or stye; ocular surface abnormality that may compromise corneal integrity (e.g. Grade 3 corneal fluorescein staining, recurrent corneal erosion, corneal epithelial defect, map dot fingerprint dystrophy, previously treated chemical burn);
• Has an eyelid abnormality that affects normal lid function (e.g. entropion, ectropion, oedema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis);
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Has any other condition that could compromise treatment or increase the risk of a procedure-related injury;

Sponsors & Collaborators

• University of Waterloo: lead
• Alcon Research: collaborator

Study Sites (1)

Centre for Ocular Research & Education

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

The study was cancelled due to COVID-19.

Results Point of Contact

• Title: Jill Woods
• Organization: Centre for Ocular Research and Education

jwoods@uwaterloo.ca

5198884567

Study Officials

• Lyndon Jones, PhD, FCOptom

  Centre for Ocular Research & Education

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: November 15, 2019
• Primary Completion: April 14, 2020
• Study Completion: April 14, 2020
• Last Updated: May 16, 2023
• Results First Posted: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)