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

NCT05279716 | Unknown Phase 4

• 1 other identifier: NO-PAPS-Study
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

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%.

Conditions

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

Keywords

prostaglandin associated peri-orbitopathy(PAPS)

Outcome Measures

Primary Outcomes (1)

• Improvement rate of DUES(Deepening of Upper Eyelid Sulcus)

  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;

  24 weeks

Secondary Outcomes (11)

• 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

Study Arms (1)

omidenepag isopropyl 0.02mg

EXPERIMENTAL

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

Drug: Eybelis ophthalmic solution 0.002%

Interventions

Eybelis ophthalmic solution 0.002% DRUG

Ophthalmic eye drop

Also known as: Omidenepag isopropyl ophthalmic solution

omidenepag isopropyl 0.02mg

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Santen Pharmaceutical Asia Pte. Ltd.: lead

Study Sites (8)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

NOT YET RECRUITING

Asan Medical Center

Seoul, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, South Korea

RECRUITING

Kim's Eye Hospital

Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Seoul ST. Mary's Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Low Tension Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases; Optic Nerve Diseases

Study Officials

• Munseok Kook

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

UMT Director

CONTACT

010-3386-0603; csyu@e-umt.com

UMT aPM

CONTACT

010-8622-9502; kskim@e-umt.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 15, 2022
• Study Start: February 15, 2022
• Primary Completion: December 8, 2022
• Study Completion: November 20, 2023
• Last Updated: March 15, 2022

Record last verified: 2022-02

Locations

KR (8)