Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
Brief Summary: The purpose of this post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.


Options:
A: Inclusion Criteria:

* Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum when MG expressed in upper or lower eyelids.
* At least one out of 8 questions on dry eye symptoms is answered with often or all the time (Appendix C, Questionnaire modified after Schein et al.,1997).
* Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.

Exclusion Criteria:

* Known history of thyroid disorders (diagnosed by physician).
* No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
* Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
* Active ocular infection or pterygium.
* Anticipated necessity to wear contact lens in the duration of the study.
* Living in the same household as another participant of the study.
* Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops (eg. Restasis) not permitted by the study.
B: Inclusion Criteria:

* Understand and sign an Informed Consent document;
* Have Meibomian Gland Dysfunction with evaporative dry eye disease at the screening visit;
* Agree not to wear contact lenses for the duration of the study;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

* History of eye surgery, as specified in the protocol;
* Eye infection or inflammation, as specified in the protocol;
* Eyelid abnormalities; eyelid tattoos;
* Treated with LipiFlow or iLux in either eye in the last 12 months;
* Contact lens wear within the 1 month prior to Screening;
* Other protocol-specified exclusion criteria may apply.
C: Key Inclusion Criteria:

* At least 22
* Subject has dry eye symptoms and uses artificial tears/lubricants regularly
* Subject has moderate to severe symptoms based on a dry eye questionnaire
* Subject has an abnormal tear break-up time
* Subject's eyelid glands secrete a low amount of meibum
* Best corrected visual acuity 20/100 or better
* Willing and able to comply with protocol
* Willing and able to provide consent
* English-speaking

Key Exclusion Criteria:

* Use of medications that treat dry eye disease or that are known to cause ocular dryness.
* Use of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, NSAIDs
* Prior office-based dry eye treatment within the past 12 months, gland expression within the past 6 months, debridement within the past 3 months, punctal plus within 30 days, TrueTear within the past 2 weeks, or meibomian gland probing.
* History of eyelid, conjunctival or corneal surgery within the past year.
* Contact lens use within past 2 weeks
* Ocular conditions or diseases that could limit the safety or effectiveness of the study treatment.
D: Inclusion Criteria:

* Be between the ages of 18 and 79 years of age.
* Must understand and be able, willing and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

* Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia..
* Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for Dry Eye Disease, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
* Active ocular allergy.
* LASIK or PRK surgery that was performed within one year of Visit 1.
* Started or changed the dose of chronic ocular medication within 30 days of visit 1.
* Contact lens worn within the past eight (8) hours.
* Any ophthalmologic drops within 2 hours of screening and visit 1 procedures.
* Pregnancy or lactation.
* Abnormality of nasolacrimal drainage (by history).
* Punctual plugs placement or cauterization within 30 days of Visit 1
* Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Visit 1.
* Systemic disease known to affect tear production or loss including, but not limited to thyroid eye disease, that has been diagnosed or has not been stable within 30 days of Visit 1.
* Known hypersensitivity to any of the agents used in testing i.e. sodium fluorescein, lissamine green, oxybuprocaine or proparacaine.

Answer: B