Status:
UNKNOWN
Study in Prostaglandin Associated Peri-orbitopathy Switching From Prostaglandin Monotherapy to Omidenepag Isopropyl
Lead Sponsor:
Santen Pharmaceutical Asia Pte. Ltd.
Conditions:
Normal Tension Glaucoma
Primary Open-angle Glaucoma
Eligibility:
All Genders
19-79 years
Phase:
PHASE4
Brief 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 in...
Detailed Description
This clinical trial is a single-arm, multicenter, prospective clinical trial, in which participants have consented to participate in the clinical trial are sequentially registered and proceeded. The ...
Eligibility Criteria
Inclusion
- 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.
- DUES (Deepening of Upper Eyelid Sulcus)
- FLEB (Flattening of Lower Eyelid Bag)
- Upper eyelid ptosis
- Periorbital hyperpigmentation
- Ciliary hypertrichosis
- Those who have agreed in writing to participate in this clinical trial.
Exclusion
- 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)
- Those who are using eye drops for the treatment of glaucoma other than Prostaglandin analogues eye drops with preservatives
- Pregnant or lactating women
- Those with hypersensitivity to anesthetic eye drops, fluorescein, or research drugs
- Those who need to wear contact lenses during the clinical trial period
- Artificial lens eye (pseudophakia) or aphakic eye (aphakia)
- Periocular trauma, surgical history, or thyroid orbitopathy affecting the evaluation of prostaglandin associated peri-orbitopathy
- Other clinical investigators judged to be inappropriate to participate in clinical trials
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05279716
Start Date
February 15 2022
End Date
November 20 2023
Last Update
March 15 2022
Active Locations (8)
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1
Seoul National University Bundang Hospital
Seongnam-si, South Korea
2
Asan Medical Center
Seoul, South Korea
3
Kangbuk Samsung Hospital
Seoul, South Korea
4
Kim's Eye Hospital
Seoul, South Korea