Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure (NCT04536129) | Clinical Trial Compass
CompletedNot Applicable
Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure
Italy90 participantsStarted 2019-11-04
Plain-language summary
Evaluation of the safety and efficacy of hydrocortisone eye drops in the treatment of OSD (ocular surface disease) patients with and without glaucoma.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.