Phase
Condition
Dry Eyes
Sjogren's Syndrome
Eyelid Inflammation
Treatment
Placebo Ophthalmic Solution (Vehicle)
IC265 Ophthalmic Solution 1%
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be at least 18 years of age;
Provide written informed consent
Have a reported or documented history of dry eye for at least 6 months prior toVisit 1
Have a history of use or desire to use eye drops for dry eye symptoms within 6months of Visit 1
Report a score of ≥ 2 on a Ocular Discomfort & 4-symptom questionnaire in at leastone symptom at Visits 1 and 2
Have a Schirmer's Test score of ≤10mm and ≥1mm in at least one eye at Visits 1and 2
Have a pre-CAE(controlled adverse environment) (conjunctival redness score ≥ 1according to the Conjunctival Redness for Dry Eye Scale in at least one eye atVisits 1 and 2
Have a corneal fluorescein staining score of ≥ 2 in at least one region (e.g.inferior, superior, or central) at Visits 1 and 2
Have a sum corneal fluorescein staining score of ≥ 4, based on the sum of theinferior, superior, and central regions at Visits 1 and 2
Have a total lissamine green conjunctival score of ≥ 2, based on the sum of thetemporal and nasal regions at Visits 1 and 2
Demonstrate a response to the CAE at Visits 1 and 2 as defined by:
Having at least a ≥1 point increase in fluorescein staining in the inferiorregion in at least one eye following CAE exposure
Reporting an Ocular Discomfort Score ≥3 at 2 or more consecutive time points inat least one eye during CAE exposure (if a subject has an ocular discomfortrating of 3 at time = 0 for an eye, s/he must report an ocular discomfortrating of 4 for two consecutive measurements for that eye) Note: a subjectcannot have an ocular discomfort score of 4 at time = 0)
Exclusion
Exclusion Criteria:
Have any clinically significant slit lamp findings at Visit 1 that may includeactive blepharitis, meibomian gland dysfunction, ocular rosacea, lid margininflammation or active ocular allergies that require therapeutic treatment
Have any clinically significant (CS) posterior chamber findings, or a history ofsuch findings/disorders, that may include exudative (i.e., wet) age-related maculardegeneration, retinal vein occlusion, diabetic retinopathy, glaucoma, ocularhypertension, or any other retinal or optic nerve disease/disorder that requiretherapeutic treatment and/or in the opinion of the Investigator may interfere withstudy parameters
Have worn contact lenses within 48 hours prior to Visit 1 or anticipate usingcontact lenses during the study
Have laser-assisted in situ keratomileusis (LASIK) or similar type of cornealrefractive surgery and/or any other ocular surgical procedure within 12 months priorto Visit 1; or have any ocular surgical procedure scheduled to be conducted duringthe study period
Have had any surgeries of the ocular surface or lid in the past 6 months
Have a history of lacrimal duct obstruction in either eye within 12 months prior toVisit 1
Have used temporary (i.e., collagen) punctal plugs within 12 weeks prior to Visit 1or anticipate their use during the study period
Have permanent punctal plugs inserted or removed - including falling out - or havehad surgical punctal occlusion within 12 weeks prior to Visit 1 or anticipate anysuch event at any time during the study period
Use any of the following treatments in the period indicated before Visit 1 oranticipate their use at any time during the study
Study Design
Connect with a study center
Iacta Selected Site
Andover, Massachusetts 01810
United StatesSite Not Available

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