Safety and Efficacy Study in NTG, POAG, Glaucoma Suspect, Ocular Hypertension Patients With Diagnosed Prostaglandin Associated Peri-orbitopathy Switching From Preserved Prostaglandin Analogues Monotherapy to Omidenepag Isopropyl
Overview
- Phase
- Phase 4
- Intervention
- Eybelis ophthalmic solution 0.002%
- Conditions
- Normal Tension Glaucoma
- Sponsor
- Santen Pharmaceutical Asia Pte. Ltd.
- Enrollment
- 150
- Locations
- 8
- Primary Endpoint
- Improvement rate of DUES(Deepening of Upper Eyelid Sulcus)
- Last Updated
- 4 years ago
Overview
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 investigators would like to confirm the real world evidence(RWE) of safety and efficacy after changing to Eybelis ophthalmic solution 0.002%.
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 participant's participation period is a total of 24 weeks after the 4-week wash-out period, and according to the visit schedule, tests according to medical procedures are conducted at Screening, Baseline, 6, 12, 18, and 24 weeks to collect data on safety and effectiveness.
Investigators
Eligibility Criteria
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.
- •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 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)
- •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
Arms & Interventions
omidenepag isopropyl 0.02mg
Instill 1 drop of Eybelis ophthalmic solution 0.002% once a day into the affected eye.
Intervention: Eybelis ophthalmic solution 0.002%
Outcomes
Primary Outcomes
Improvement rate of DUES(Deepening of Upper Eyelid Sulcus)
Time Frame: 24 weeks
Primary efficacy parameter in prostaglandin associated peri-orbitopathy diseases at 24 weeks compared to baseline. -DUES (Deepening of Upper Eyelid Sulcus) Evaluate based on the following criteria. Grading is evaluated from 0 to 4 points. grade 0 = none; grade 1 = trace, barely visible; grade 2 = mild; grade 3 = moderate, easily detected; grade 4 = severe;
Secondary Outcomes
- Improvement rate of FLEB (Flattening of Lower Eyelid Bag)(24 weeks)
- Improvement rate of Upper eyelid ptosis in prostaglandin-associated peri-orbitopathy(24 weeks)
- Improvement rate of Periorbital hyperpigmentation in prostaglandin-associated peri-orbitopathy(24 weeks)
- Improvement rate of Ciliary hypertrichosis in prostaglandin-associated peri-orbitopathy(24 weeks)
- Changes in intraocular pressure (IOP)(24 weeks)
- Response rate of changes in intraocular pressure (IOP)(24 weeks)
- Expression rate, number and change of Conjunctival Hyperemia(24 weeks)
- Expression rate, number and change of Macular Edema(24 weeks)
- Expression rate, number and change of Cystoid Macular Edema(24 weeks)
- Expression rate, number and change of Endothelial Cell Count(24 weeks)
- Expression rate, number and change of Central Corneal Thickness(24 weeks)