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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-11-20

Brief Summary

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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%.

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Detailed Description

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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.

Conditions

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Normal Tension Glaucoma Primary Open-angle Glaucoma Glaucoma, Suspect Ocular Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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omidenepag isopropyl 0.02mg

Instill 1 drop of Eybelis ophthalmic solution 0.002% once a day into the affected eye.

Group Type EXPERIMENTAL

Eybelis ophthalmic solution 0.002%

Intervention Type DRUG

Ophthalmic eye drop

Interventions

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Eybelis ophthalmic solution 0.002%

Ophthalmic eye drop

Intervention Type DRUG

Other Intervention Names

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Omidenepag isopropyl ophthalmic solution

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No