Clinical trial NCT05279716: Study in Prostaglandin Associated Peri-orbitopathy Switching From Prostaglandin Monotherapy to Omidenepag Isopropyl
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Normal Tension Glaucoma
Primary Open-angle Glaucoma
Glaucoma, Suspect
Ocular Hypertension
Keywords: prostaglandin associated peri-orbitopathy(PAPS)
Lead sponsor: Santen Pharmaceutical Asia Pte. Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-15
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Improvement rate of DUES(Deepening of Upper Eyelid Sulcus)
timeFrame: 24 weeks
Secondary outcomes:
measure: Improvement rate of FLEB (Flattening of Lower Eyelid Bag)
timeFrame: 24 weeks
measure: Improvement rate of Upper eyelid ptosis in prostaglandin-associated peri-orbitopathy
timeFrame: 24 weeks
measure: Improvement rate of Periorbital hyperpigmentation in prostaglandin-associated peri-orbitopathy
timeFrame: 24 weeks
measure: Improvement rate of Ciliary hypertrichosis in prostaglandin-associated peri-orbitopathy
timeFrame: 24 weeks
measure: Changes in intraocular pressure (IOP)
timeFrame: 24 weeks
measure: Response rate of changes in intraocular pressure (IOP)
timeFrame: 24 weeks
measure: Expression rate, number and change of Conjunctival Hyperemia
timeFrame: 24 weeks
measure: Expression rate, number and change of Macular Edema
timeFrame: 24 weeks
measure: Expression rate, number and change of Cystoid Macular Edema
timeFrame: 24 weeks
measure: Expression rate, number and change of Endothelial Cell Count
timeFrame: 24 weeks
measure: Expression rate, number and change of Central Corneal Thickness
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Asan Medical Center
name: Munseok Kook
role: PRINCIPAL_INVESTIGATOR
References: