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 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT02455895
Eligibility Criteria:
Inclusion Criteria:
* Male or female, of any race, at least 6 years of age.
* Must be eligible for a recommendation to use eye lid cleansing/scrubs for:
* Signs of acute or chronic blepharitis, such as eye lid debris (sleeves, collorates, flakes, crusting) requiring eye lid cleansing/scrubs, and/or
* Signs consistent with mild, moderate, or severe meibomian gland disease (MGD) such as dilated and blocked glands with inspissated secretions sluggish or stagnant upon expression.
* Must be able to read, understand and sign an informed consent form that has been approved by an Institutional Review Board/Ethics Committee. If subject is less than 18 years of age, the informed consent must be signed and dated by subject's legally authorized representative (parent or guardian). Assent to participate should also be obtained from subjects under 18 years of age if required by local regulation.
* Must agree to comply with the visit schedule and other requirements of the study. The parent or guardian must agree to ensure compliance of subjects less than 18 years of age.
* Must agree to remove contact lenses, if applicable, for 15 minutes before and after application of the study Investigational Product.
* Must agree for the duration of the study to refrain from use of makeup/cosmetic products used around the eye(s) such as eye liner, mascara, and/or shadow, foundation or powder. Use of such products is allowed if the eyelid skin area is avoided.
Exclusion Criteria:
* Presence of signs and symptoms of bacterial or allergic conjunctivitis or allergic dermatitis at the Day 1 Visit.
* Suspected fungal, viral, Chlamydia or Acanthamoeba infection based on clinical diagnosis.
* Visual acuity not correctable to 1.0 LogMAR or better (equivalent to Snellen 20/200) in either eye using either a Snellen or ETDRS chart.
* Use of any topical ocular medications including tear substitutes during study participation.
* Use of any preserved or non-preserved glaucoma medications during the 14 days prior to Visit 1 and anticipated use during study participation.
* Presence of nasolacrimal duct obstruction.
* Presence of a punctal plug in either eye.
* Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
* Presence of active inflammation and/or active structural change in the cornea, iris or anterior chamber at the Day 1 visit.
* Use of any topical ocular or oral antimicrobial agent within the 3 days prior to Day 1 visit.
* Use of topical ocular corticosteroids or non-steroidal topical ocular anti-inflammatories (NSAIDs), within 3 days prior to study entry and during the trial.
* Use of RESTASIS® (Cyclosporine Ophthalmic Emulsion) 0.05%) in either eye during the trial.
* Any current immunosuppressive disorder (e.g., HIV positive), or use of immunosuppressive therapy (including chemotherapy).
* Participation in any other investigational clinical study within 30 days prior to study enrollment.
* Any subject who is on staff at the investigational site or is a family member of staff personnel.
* Additionally, the Investigator or Medical Monitor may declare any subject ineligible for a sound medical reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT02455895
Study Brief:
Protocol Section:
NCT02455895