Trials / Unknown
UnknownNCT05279716
Study in Prostaglandin Associated Peri-orbitopathy Switching From Prostaglandin Monotherapy to Omidenepag Isopropyl
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
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Santen Pharmaceutical Asia Pte. Ltd. · Industry
- Sex
- All
- Age
- 19 Years – 79 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eybelis ophthalmic solution 0.002% | Ophthalmic eye drop |
Timeline
- Start date
- 2022-02-15
- Primary completion
- 2022-12-08
- Completion
- 2023-11-20
- First posted
- 2022-03-15
- Last updated
- 2022-03-15
Locations
8 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05279716. Inclusion in this directory is not an endorsement.