Prospective evaluation of the efficacy and safety of topical hydrocortisone treatment on clinical signs and symptoms of dry eye disease associated with moderate meibomian gland dysfunction

Dry Eye and Meibomian Gland Dysfunction

Efficacy: Change in MGD-DE symptom score from D0 to D14., Exploratory: Change from D0 value to D14 (both eyes) in level of the following inflammatory cytokines in tears: IL-6, TNF alpha, IL-1b, IL-10, IFNγ, IL-17A, IL-2, IL-4. First eye to sample will be the study eye., Safety: Incidence of increased intraocular pressure (IOP). Change in IOP between D0, D14, D28 and D84.

Efficacy: Ocular Symptoms • Change in OSDI score between D0 and D14, D28 and D84. • Change in MGD-DE symptom score from D0 to D28 and D84. • Change in VAS score of each of 7 symptoms (itching, dry eye sensation, burning, foreign body sensation, ocular redness, ocular fatigue, and blurry vision) between D0 and D14, D28 and D84., Efficacy: Ocular signs of DED • Change in hyperemia score (McMonnies – Chapman scale) between D0 and D14, D28 and D84. • Change in TBUT between D0 and D14, D28 and D84. • Change in corneal and conjunctival staining with fluorescein (Oxford grading scale) between D0 and D14, D28 and D84. • Change in corneal and conjunctival staining with lissamine green (Van Bijsterveld scale) between D0 and D14, D28 and D84. • Change in Schirmer I test between D0 and D14, D28 and D84., Efficacy: Ocular signs of MGD • Change in grading of MGD according to a graduation from 0 to 4 between D0 and D84. • Change in lid abnormality score according to a graduation from 0 to 2, where 0 is no findings and 2 is severe findings, between D0 an, Safety: • Incidence of adverse events (AE) and serious adverse events (SAE) occurred during the study. • Change in visual acuity between D0, D14, D28 and D84. Early Treatment Diabetic Retinopathy Study (ETDRS) scale will be used.

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