Investigating iLux Efficacy in Contact Lens Wearers With Evaporative Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: iLux® system
Intervention description: Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is at least 18 years of age and has full legal capacity to volunteer;

          2. Has read and signed an information consent letter;

          3. Is willing and able to follow instructions and maintain the appointment schedule;

          4. Has been using the same CL type (brand, material and dimensions) for > 3 months;

          5. Wears commercially available soft CLs on average >2 hours per day, 4-7 days per week;

          6. 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;

          7. Demonstrates an acceptable lens fit of their habitual contact lenses;

          8. Does not have contact lens discomfort due to contact lens fit, lens material or known
             solution compatibility issues, in the opinion of the investigator;

          9. Has at least one month supply of their habitual contact lens products at the time of
             the screening visit;

         10. Has a CLDEQ-8 score ≥ 12;

         11. Has dry eye symptoms without CL wear (OSDI ≥ 13) and has at least one of the two
             following signs:

               1. Non-invasive tear break-up time (NITBUT) of < 10 seconds in at least one eye;

               2. Fluorescein staining: > 5 spots of corneal staining OR > 9 conjunctival spots OR
                  lid wiper staining (≥ 2mm length, ≥ 25% width) in at least one eye;

         12. Has a lipid layer thickness of ≤ 100 nm in both eyes;

         13. A meibomian gland secretion score (MGS) of ≤ 15 for 15 glands of the lower lid in both
             eyes.

        Exclusion Criteria:

          1. Is participating in any concurrent clinical or research study;

          2. 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);

          3. Has previously received treatment with an eyelid thermal pulsation device;

          4. 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:

               1. Ocular trauma

               2. Chemical burns

               3. Ocular Herpes simplex or Herpes zoster infection

               4. Limbal stem cell deficiency

               5. Recurrent ocular inflammation (e.g. uveitis, iritis, scleritis, episcleritis,
                  keratitis)

          5. Has undergone ocular surgery (e.g. intraocular, oculoplastic, corneal or refractive
             surgery procedure) within the past 12 months prior to the screening visit;

          6. Has permanent make-up or tattoos on their eyelids;

          7. 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);

          8. Has an eyelid abnormality that affects normal lid function (e.g. entropion, ectropion,
             oedema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis);

          9. Has a systemic condition that in the opinion of the investigator may affect a study
             outcome variable;

         10. Has any other condition that could compromise treatment or increase the risk of a
             procedure-related injury;

         11. Is using any systemic or topical medications that in the opinion of the investigator
             may affect a study outcome variable;

         12. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

         13. Has a history of sensitivity to rapidly blinking lights or photosensitive epilepsy;

         14. Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time
             of enrolment;

         15. Is aphakic;

         16. Is a member of CORE directly involved in the study;

         17. Has taken part in a clinical research study within the last 30 days. * For the
             purposes of this study, active ocular disease is defined as infection or inflammation
             which requires therapeutic treatment. Mild (i.e. not considered clinically relevant)
             lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and
             conjunctival staining and dry eye are not considered active ocular disease.
             Neovascularization and corneal scars are the result of previous hypoxia, infection or
             inflammation and are therefore not active.