Table 1.

Enrollment criteria

Key inclusion criteria

1. Be age ≥ 18 years at the screening visit 2. Have normal lid anatomy 3. Have a reported history of severe keratitis in one or both eyes and a history of previous treatment for keratitis within the previous 6 months 4. Did not have symptomatic improvement or did not tolerate previous treatment with topical cyclosporine or lifitegrast 5. Have all the following in at least one eye (the same eye) at screening and baseline:  (a) Inferior corneal fluorescein staining score ≥ 2 in any field  (b) Corneal sum fluorescein staining score ≥ 4  (c) Conjunctival sum lissamine green staining score ≥ 2  (d) Conjunctival redness score ≥ 1  (e) Schirmer score ≥ 1 mm/5 min and ≤ 10 mm/5 min  (f) Ocular discomfort score (ODS) ≥ 2

Key exclusion criteria

1. Have any ocular condition that, in the opinion of the investigator, could affect study parameters 2. Have a history of laser-assisted in situ keratomileusis (LASIK) and/or any other ocular surgical procedure within 12 months prior to the baseline visit; ocular trauma, penetrating intraocular surgery, refractive surgery, corneal transplantation, or eyelid surgery within 12 weeks prior to the screening visit; or any scheduled ocular surgical procedure during the study phase 3. Have active or any history of ocular herpes or other ocular infection within 30 days prior to the baseline visit 4. Have current punctal plugs, punctal occlusion, or a history of nasolacrimal duct obstruction 5. Be unwilling to avoid wearing contact lenses for 7 days prior to the screening visit and for the duration of the study phase 6. Have a best-corrected visual acuity < 0.7 logarithm of the minimum angle of resolution (logMAR) in each eye at the screening and baseline visits 7. Be under treatment with any corticosteroids, immunosuppressants, immunomodulators, or biologic agents for a concomitant condition 8. Use prohibited medications or devices and be unable to discontinue their use for the required period before entry into the study, as follows:  (a) Ophthalmic cyclosporine or lifitegrast within 12 weeks prior to the screening visit  (b) Topical and systemic corticosteroids, antibiotics, mast cell stabilizers, and vasoconstrictors and ocular autologous serum within 30 days prior to the screening visit  (c) Systemic tetracyclines, unless the dose has been stable for ≥ 30 days prior to the screening visit and will remain stable during the study phase  (d) Any topical or systemic medication known to cause ocular drying, unless the dose has been stable for ≥ 30 days prior to the screening visit and will remain stable during the study phase  (e) Topical and systemic antihistamines within 7 days prior to the screening visit  (f) Topical or nasal vasoconstrictors within 14 days prior to the screening visit  (g) Unable to refrain from using artificial tears within 2 h prior to each study visit  (h) Has had glucocorticoid implants within 3 years prior to the baseline visit or has had complications related to the device and/or has had the device removed within 90 days prior to the baseline visit  (i) Any US Food and Drug Administration (FDA)-approved medical devices other than punctal plugs for dry eye within 12 weeks prior to the screening visit

FDA US Food and Drug Administration, LASIK laser-assisted in situ keratomileusis, logMAR Logarithm of the Minimum Angle of Resolution, ODS ocular discomfort score