Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT03055832
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and older of any gender or race
* Written informed consent to participate in the study
* Willingness and ability to return for all study visits
* Positive history of self-reported dry eye symptoms for three months prior to the study using OSDI with a score of ≥ 23 at the baseline visit
* Evidence of meibomian gland (MG) obstruction, based on total MGS of ≤12 in lower eyelids for each eye as assessed by a clinician not involved in the study procedure
* Tear break-up time \<10 seconds
* Agreement/ability to abstain from dry eye/MGD medications for the time between the screening visit and the final study visit (ocular lubricants are allowed if no changes are made during the study)
Exclusion Criteria:
* History of ocular or corneal surgery including intraocular, oculo-plastic, corneal or refractive surgery within 1 year
* Subjects with giant papillary conjunctivitis
* Subject with punctal plugs or who have had punctal cautery
* Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination
* Active ocular herpes zoster or simplex of eye or eyelid or a history of these within the last 3 months
* Subjects who are aphakic
* Cicatricial lid margin disease identified via slit lamp examination, including pemphigoid, symblepharon, etc.
* Active ocular infection
* Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
* Ocular surface abnormality that may compromise corneal integrity
* Lid surface abnormalities that affect lid function in either eye
* Anterior blepharitis (staphylococcal, demodex or seborrheic grade 3 or 4)
* Systemic disease conditions that cause dry eye
* Unwillingness to abstain from systemic medications known to cause dryness for the study duration
* Women who are pregnant, nursing, or not utilizing adequate birth control measures
* Individuals who have either changed the dosing of systemic medications or non-dry eye/MGD ophthalmic medications within the past 30 days prior to screening
* Individuals who are unable or unwilling to remain on a stable dosing regimen for the duration of the study
* Individuals using isotretinoin (Accutane) within 1 year, cyclosporine-A (Restasis) or lifitegrast ophthalmic solution 5% (Xiidra) within 3 months, or any other dry eye or MGD medications within 2 weeks of screening (ocular lubricants are allowed if no changes are made during the study)
* Individuals wearing contact lenses at any time during the prior three months or during the study period
* Eyelid tattoos, including permanent eyeliner makeup
* Individuals that were treated with LipiFlow in either eye in the last 24 months
* Individuals using another ophthalmic investigational device or agent within 30 days of study participation
* Individuals who are unable to complete the required patient questionnaires in English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03055832
Study Brief:
Protocol Section:
NCT03055832