Study in Prostaglandin Associated Peri-orbitopathy Switching From Prostaglandin Monotherapy to Om… (NCT05279716) | Clinical Trial Compass
UnknownPhase 4
Study in Prostaglandin Associated Peri-orbitopathy Switching From Prostaglandin Monotherapy to Omidenepag Isopropyl
South Korea150 participantsStarted 2022-02-15
Plain-language summary
This study is for patients have been using prostaglandin analogue eye drops with a preservative for 3 months or more and have been diagnosed with prostaglandin-associated peri-orbital disease.
the investigators would like to confirm the real world evidence(RWE) of safety and efficacy after changing to Eybelis ophthalmic solution 0.002%.
Who can participate
Age range19 Years – 79 Years
SexALL
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Inclusion criteria
✓. Adults between 19 and 79 years of age.
✓. Normal Tension Glaucoma, Primary open-angle glaucoma, Glaucoma suspect and Ocular hypertension patients.
✓. Patients who have received prostaglandin analogue (PGA) eye drops with preservatives for at least 3 months from the date of consent.
✓. Patients diagnosed with prostaglandin associated peri-orbitopathy due to the use of Prostaglandin analogue (PGA) eye drops with preservatives.
✓. Those who have agreed in writing to participate in this clinical trial.
Exclusion criteria
✕. Patients with glaucoma caused by secondary causes such as pseudo-exfoliative glaucoma and pigment dispersion syndrome
✕. Patients with intraocular pressure greater than 34 mmHg
✕. Patients with severe visual impairment (Mean deviation -20dB or more)
✕. History of eye surgery within 6 months from the date of consent (Corneal refractive surgery or intraocular surgery including LASIK and LASEK that affect the condition of the ocular surface)
✕. Patients with severe dry eyes (those receiving or in need of drug treatment), those with eye allergies, infections, or inflammatory diseases
✕. Those who are using systemic or eye steroids (except for topical skin)
✕
What they're measuring
1
Improvement rate of DUES(Deepening of Upper Eyelid Sulcus)