The COAT Trial: Cequa's Onset of Action Trial

Exclusion Criteria

• •Ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
• •Clinically significant ocular trauma.
• •Active ocular Herpes simplex or Herpes Zoster infection
• •Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
• •Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
• •Active, systemic, or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings.
• •Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
• •Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
• •Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
• •Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
• •Participation in this trial in the same patient's fellow eye
• •Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.