Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure

• Status: Completed
• Trial end date: 2020-03-04
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the safety and efficacy of hydrocortisone eye drops in the treatment of OSD (ocular surface disease) patients with and without glaucoma.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Molise
• Collaborator: Medivis
• Treatments: Hydrocortisone

Criteria

Inclusion Criteria:

• age of at least 18 years

• diagnosis of OSD (Ocular Surface Disease)

• normal ophthalmic findings except history of OSD for at least 3 months, and current therapy with topical lubricants for at least 3 months

• POAG (primary open-angle glaucoma ) patients on medical therapy

Exclusion Criteria:

• clinically significant slit lamp findings at screening visit except OSD

• participation in a clinical trial in the 4 weeks preceding the screening visit

• symptoms of a clinically relevant illness in the 3 weeks before the screening visit

• presence/ history of a severe medical or surgical condition

• intake of parasympathomimetic or antipsychotic drugs

• wearing of contact lenses

• previous refractive laser surgery (e.g photorefractive keratectomy-PRK, laser assisted in situ keratomileusis-LASIK, etc.)

• history of IOP increase caused by systemic or topical treatment with corticosteroids

• IOP greater than 22 mmHg

• treatment with corticosteroids in the 4 weeks preceding the study

• types of glaucoma other than POAG

• ocular infection or clinically significant inflammation

• ocular surgery in the 3 months preceding the study

• Sjögren's syndrome, Stevens-Johnson syndrome

• history of allergic conjunctivitis

• pregnancy, planned pregnancy or lactating

• known hypersensitivity to any component of study medication