Topical preservative-free hydrocortisone 0.335% improves signs and symptoms in patients with chronic dry eye disease and reduces ocular surface inflammation

Session Details

Session Title: Presented Poster Session: Medical Cornea

Venue: Poster Village: Pod 3

First Author: : D.Schmidl AUSTRIA

Co Author(s): :    M. Kallab   N. Hommer   S. Szegedi   R. Werkmeister   L. Schmetterer   G. Garhöfer        

Abstract Details

Purpose:

Dry Eye Disease (DED) is a complex multifactorial disease with ocular surface inflammation playing a key role in the pathophysiological process. Thus, anti-inflammatory agents are recommended when treatment with topical lubricants alone is considered insufficient. Here, we investigate the safety and efficacy of a short-term treatment with new topical low dose hydrocortisone 0.335% preservative free eye drops in patients with moderate to severe DED.

Setting:

Sixty patients (mean-age: 51±14 years) with moderate to severe DED were included in this randomized, observer masked, parallel group, phase IV study.

Methods:

Patients were randomized to receive either hydrocortisone 0.335% for 12 days 4 times daily followed by 2 days twice daily instillation (intense treatment group) or 8 days 3 daily instillation followed by 3 days twice daily instillation (recommended treatment group). Conjunctival hyperemia was assessed using the Efron scale at baseline, at day 14 and 28, respectively. Measurement of intraocular pressure (IOP) and standard clinical tests to assess signs and symptoms including ocular surfaces disease index (OSDI) were performed.

Results:

Conjunctival hyperemia significantly decreased by 23.9±21.2% in the intense and by 27.5±23.3% in the recommended treatment group (p<0.001 each) with no statistical difference between the groups. In addition, OSDI significantly decreased from baseline during the study period in both study groups (p<0.001, by 19.5±39.1% and 24.1±33.9%, respectively) after hydrocortisone treatment. IOP did not change at the end of the treatment period in neither the intense treatment group (baseline: 14.1±1.8mmHg; day 14: 13.9±2.0mmHg) nor in the recommended treatment group (baseline: 12.8±1.9mmHg; day 14: 13.3±2.1mmHg).

Conclusions:

Treatment with low-dose hydrocortisone 0.335% reduced ocular inflammation as assessed using the Efron scale and clinical signs and symptoms of DED . No change in IOP was observed after hydrocortisone treatment in neither of the two treatment schedules. Because of its good safety profile, low dose hydrocortisone may be an interesting alternative to standard corticosteroid treatment to cut the vicious circle of inflammation in DED.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented