a study to assess the safety and efficacy of ic265 ophthalmic solution for dry eye in adult participants

Conditions: Dry Eye Syndromes

Summary: this study will evaluate the safety, tolerability and efficacy of ic265 compared to vehicle in participants with signs and symptoms dry eye disease.


Eligibility criteria:
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 to visit 1 * have a history of use or desire to use eye drops for dry eye symptoms within 6 months of visit 1 * report a score of ≥ 2 on a ocular discomfort \& 4-symptom questionnaire in at least one 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 ≥ 1 according to the conjunctival redness for dry eye scale in at least one eye at visits 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 the inferior, superior, and central regions at visits 1 and 2 * have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal and nasal regions at visits 1 and 2 * demonstrate a response to the cae at visits 1 and 2 as defined by: 1. having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following cae exposure 2. reporting an ocular discomfort score ≥3 at 2 or more consecutive time points in at least one eye during cae exposure (if a subject has an ocular discomfort rating of 3 at time = 0 for an eye, s/he must report an ocular discomfort rating of 4 for two consecutive measurements for that eye) note: a subject cannot have an ocular discomfort score of 4 at time = 0) exclusion criteria: * have any clinically significant slit lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction, ocular rosacea, lid margin inflammation or active ocular allergies that require therapeutic treatment * have any clinically significant (cs) posterior chamber findings, or a history of such findings/disorders, that may include exudative (i.e., wet) age-related macular degeneration, retinal vein occlusion, diabetic retinopathy, glaucoma, ocular hypertension, or any other retinal or optic nerve disease/disorder that require therapeutic treatment and/or in the opinion of the investigator may interfere with study parameters * have worn contact lenses within 48 hours prior to visit 1 or anticipate using contact lenses during the study * have laser-assisted in situ keratomileusis (lasik) or similar type of corneal refractive surgery and/or any other ocular surgical procedure within 12 months prior to visit 1; or have any ocular surgical procedure scheduled to be conducted during the 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 to visit 1 * have used temporary (i.e., collagen) punctal plugs within 12 weeks prior to visit 1 or anticipate their use during the study period * have permanent punctal plugs inserted or removed - including falling out - or have had surgical punctal occlusion within 12 weeks prior to visit 1 or anticipate any such event at any time during the study period * use any of the following treatments in the period indicated before visit 1 or anticipate their use at any time during the study