Study in Prostaglandin Associated Peri-orbitopathy Switching From Prostaglandin Monotherapy to Omidenepag Isopropyl

• Status: Recruiting
• Trial end date: 2023-11-20
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Pharmaceutical Asia Pte. Ltd.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Adults between 19 and 79 years of age.

2. Normal Tension Glaucoma, Primary open-angle glaucoma, Glaucoma suspect and Ocular hypertension patients.

3. Patients who have received prostaglandin analogue (PGA) eye drops with preservatives for at least 3 months from the date of consent.

4. 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

5. Those who have agreed in writing to participate in this clinical trial.

Exclusion Criteria:

1. Patients with glaucoma caused by secondary causes such as pseudo-exfoliative glaucoma and pigment dispersion syndrome

2. Patients with intraocular pressure greater than 34 mmHg

3. Patients with severe visual impairment (Mean deviation -20dB or more)

4. 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)

5. Patients with severe dry eyes (those receiving or in need of drug treatment), those with eye allergies, infections, or inflammatory diseases

6. Those who are using systemic or eye steroids (except for topical skin)

7. Those who are using eye drops for the treatment of glaucoma other than Prostaglandin analogues eye drops with preservatives

8. Pregnant or lactating women

9. Those with hypersensitivity to anesthetic eye drops, fluorescein, or research drugs

10. Those who need to wear contact lenses during the clinical trial period

11. Artificial lens eye (pseudophakia) or aphakic eye (aphakia)

12. Periocular trauma, surgical history, or thyroid orbitopathy affecting the evaluation of prostaglandin associated peri-orbitopathy

13. Other clinical investigators judged to be inappropriate to participate in clinical trials