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

Primary Purpose

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

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Eybelis ophthalmic solution 0.002%
Sponsored by
Santen Pharmaceutical Asia Pte. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Normal Tension Glaucoma focused on measuring prostaglandin associated peri-orbitopathy(PAPS)

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Asan Medical CenterRecruiting
  • Kangbuk Samsung HospitalRecruiting
  • Kim's Eye HospitalRecruiting
  • Korea University Anam HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Seoul ST. Mary's HospitalRecruiting
  • Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

omidenepag isopropyl 0.02mg

Arm Description

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

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

Improvement rate of FLEB (Flattening of Lower Eyelid Bag)
second efficacy parameter in prostaglandin associated peri-orbitopathy diseases at 24 weeks compared to baseline. Facial photos, including eyebrows and lower eyelids, are taken by the investigator with the same digital camera and without flash in the same room conditions. When registering participants, the principal investigator of the conducting institution evaluates and registers participants, and the final evaluation is evaluated by three independent evaluators by randomly arranging the pictures taken during the visit so that the order of the visit is unknown.
Improvement rate of Upper eyelid ptosis in prostaglandin-associated peri-orbitopathy
second efficacy parameter in prostaglandin associated peri-orbitopathy diseases at 24 weeks compared to baseline. -Upper eyelid ptosis Margin reflex distance (MRD) is measured, and MRD 1 and MRD 2 are measured, respectively. This is measured to evaluate the palpebral fissure height. Grading is evaluated by the difference between the values of MRD 1 and MRD 2. mild = less than 2 mm; moderate = more than 2 mm and less than 4 mm; severe = more than 4 mm;
Improvement rate of Periorbital hyperpigmentation in prostaglandin-associated peri-orbitopathy
second efficacy parameter in prostaglandin associated peri-orbitopathy diseases at 24 weeks compared to baseline. -Periorbital hyperpigmentation Periorbital hyperpigmentation around the eyes is evaluated compared to the surrounding skin. Grading is evaluated from 0 to 4 points. grade 0 = skin color comparable to other facial skin areas; grade 1 = faint pigmentation of infraorbital fold; grade 2 = pigmentation more pronounced; grade 3 = deep dark color, all four lids involved; grade 4 = grade 3+ pigmentation spreading beyond infraorbital fold;
Improvement rate of Ciliary hypertrichosis in prostaglandin-associated peri-orbitopathy
second efficacy parameter in prostaglandin associated peri-orbitopathy diseases at 24 weeks compared to baseline. Facial photos, including eyebrows and lower eyelids, are taken by the investigator with the same digital camera and without flash in the same room conditions. When registering participants, the principal investigator of the conducting institution evaluates and registers participants, and the final evaluation is evaluated by three independent evaluators by randomly arranging the pictures taken during the visit so that the order of the visit is unknown.
Changes in intraocular pressure (IOP)
second efficacy parameter in intraocular pressure at 24 weeks compared to baseline.
Response rate of changes in intraocular pressure (IOP)
second efficacy parameter in Response rate of changes in intraocular pressure at 24 weeks compared to baseline.
Expression rate, number and change of Conjunctival Hyperemia
- Conjunctival Hyperemia Conjunctival Hyperemia is performed according to the evaluation criteria of the Japanese Ocular Allergy Society (JOAS). Grading is evaluated from 0 to 3 points. Grade 0 = No vasodilation; Grade 1= Some vessel vasodilation; Grade 2 = Excessive vessel vasodilation; Grade 3 = Overall vasodilation;
Expression rate, number and change of Macular Edema
-Macular Edema Inspect with Optical Coherence Tomography. Clinically significant macular edema in the following cases evaluate. Thickening of the retina at or within 500 μm of the center of the macula. Hard exudates at or within 500 μm of the center of the macula that associated with thickening of adjacent retina (which may lie more than 500 μm from the center of the macula). A zone or zones of retinal thickening 1 disc area or larger, any part of which is within 1 disc diameter of the center of the macula
Expression rate, number and change of Cystoid Macular Edema
-Cystoid Macular Edema Inspect with Optical Coherence Tomography. CME I = cysts less than 30% macular thickness; CME II = cysts between 30% and 60% of macular thickness; CME III = cysts between 60% and 90% of macular thickness; CME IV = cysts became more than 90% of the macular thickness;
Expression rate, number and change of Endothelial Cell Count
-Endothelial Cell Count Measure with a specular microscope and check CD (Cell Density, cells/mm^2), CV (Coefficient of Variation), HEX (Hexagonality, %), NUM (number excluding incorrect count cells when counting cells) do.
Expression rate, number and change of Central Corneal Thickness
-Central Cornea Thickness After eye drop anesthesia, it is measured with an Ultrasonic Pachymeter(μm).

Full Information

First Posted
February 24, 2022
Last Updated
March 6, 2022
Sponsor
Santen Pharmaceutical Asia Pte. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05279716
Brief Title
Study in Prostaglandin Associated Peri-orbitopathy Switching From Prostaglandin Monotherapy to Omidenepag Isopropyl
Acronym
NOPAPS
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
December 8, 2022 (Anticipated)
Study Completion Date
November 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Asia Pte. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Tension Glaucoma, Primary Open-angle Glaucoma, Glaucoma, Suspect, Ocular Hypertension
Keywords
prostaglandin associated peri-orbitopathy(PAPS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
omidenepag isopropyl 0.02mg
Arm Type
Experimental
Arm Description
Instill 1 drop of Eybelis ophthalmic solution 0.002% once a day into the affected eye.
Intervention Type
Drug
Intervention Name(s)
Eybelis ophthalmic solution 0.002%
Other Intervention Name(s)
Omidenepag isopropyl ophthalmic solution
Intervention Description
Ophthalmic eye drop
Primary Outcome Measure Information:
Title
Improvement rate of DUES(Deepening of Upper Eyelid Sulcus)
Description
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;
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Improvement rate of FLEB (Flattening of Lower Eyelid Bag)
Description
second efficacy parameter in prostaglandin associated peri-orbitopathy diseases at 24 weeks compared to baseline. Facial photos, including eyebrows and lower eyelids, are taken by the investigator with the same digital camera and without flash in the same room conditions. When registering participants, the principal investigator of the conducting institution evaluates and registers participants, and the final evaluation is evaluated by three independent evaluators by randomly arranging the pictures taken during the visit so that the order of the visit is unknown.
Time Frame
24 weeks
Title
Improvement rate of Upper eyelid ptosis in prostaglandin-associated peri-orbitopathy
Description
second efficacy parameter in prostaglandin associated peri-orbitopathy diseases at 24 weeks compared to baseline. -Upper eyelid ptosis Margin reflex distance (MRD) is measured, and MRD 1 and MRD 2 are measured, respectively. This is measured to evaluate the palpebral fissure height. Grading is evaluated by the difference between the values of MRD 1 and MRD 2. mild = less than 2 mm; moderate = more than 2 mm and less than 4 mm; severe = more than 4 mm;
Time Frame
24 weeks
Title
Improvement rate of Periorbital hyperpigmentation in prostaglandin-associated peri-orbitopathy
Description
second efficacy parameter in prostaglandin associated peri-orbitopathy diseases at 24 weeks compared to baseline. -Periorbital hyperpigmentation Periorbital hyperpigmentation around the eyes is evaluated compared to the surrounding skin. Grading is evaluated from 0 to 4 points. grade 0 = skin color comparable to other facial skin areas; grade 1 = faint pigmentation of infraorbital fold; grade 2 = pigmentation more pronounced; grade 3 = deep dark color, all four lids involved; grade 4 = grade 3+ pigmentation spreading beyond infraorbital fold;
Time Frame
24 weeks
Title
Improvement rate of Ciliary hypertrichosis in prostaglandin-associated peri-orbitopathy
Description
second efficacy parameter in prostaglandin associated peri-orbitopathy diseases at 24 weeks compared to baseline. Facial photos, including eyebrows and lower eyelids, are taken by the investigator with the same digital camera and without flash in the same room conditions. When registering participants, the principal investigator of the conducting institution evaluates and registers participants, and the final evaluation is evaluated by three independent evaluators by randomly arranging the pictures taken during the visit so that the order of the visit is unknown.
Time Frame
24 weeks
Title
Changes in intraocular pressure (IOP)
Description
second efficacy parameter in intraocular pressure at 24 weeks compared to baseline.
Time Frame
24 weeks
Title
Response rate of changes in intraocular pressure (IOP)
Description
second efficacy parameter in Response rate of changes in intraocular pressure at 24 weeks compared to baseline.
Time Frame
24 weeks
Title
Expression rate, number and change of Conjunctival Hyperemia
Description
- Conjunctival Hyperemia Conjunctival Hyperemia is performed according to the evaluation criteria of the Japanese Ocular Allergy Society (JOAS). Grading is evaluated from 0 to 3 points. Grade 0 = No vasodilation; Grade 1= Some vessel vasodilation; Grade 2 = Excessive vessel vasodilation; Grade 3 = Overall vasodilation;
Time Frame
24 weeks
Title
Expression rate, number and change of Macular Edema
Description
-Macular Edema Inspect with Optical Coherence Tomography. Clinically significant macular edema in the following cases evaluate. Thickening of the retina at or within 500 μm of the center of the macula. Hard exudates at or within 500 μm of the center of the macula that associated with thickening of adjacent retina (which may lie more than 500 μm from the center of the macula). A zone or zones of retinal thickening 1 disc area or larger, any part of which is within 1 disc diameter of the center of the macula
Time Frame
24 weeks
Title
Expression rate, number and change of Cystoid Macular Edema
Description
-Cystoid Macular Edema Inspect with Optical Coherence Tomography. CME I = cysts less than 30% macular thickness; CME II = cysts between 30% and 60% of macular thickness; CME III = cysts between 60% and 90% of macular thickness; CME IV = cysts became more than 90% of the macular thickness;
Time Frame
24 weeks
Title
Expression rate, number and change of Endothelial Cell Count
Description
-Endothelial Cell Count Measure with a specular microscope and check CD (Cell Density, cells/mm^2), CV (Coefficient of Variation), HEX (Hexagonality, %), NUM (number excluding incorrect count cells when counting cells) do.
Time Frame
24 weeks
Title
Expression rate, number and change of Central Corneal Thickness
Description
-Central Cornea Thickness After eye drop anesthesia, it is measured with an Ultrasonic Pachymeter(μm).
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UMT Director
Phone
010-3386-0603
Ext
+82
Email
csyu@e-umt.com
First Name & Middle Initial & Last Name or Official Title & Degree
UMT aPM
Phone
010-8622-9502
Ext
+82
Email
kskim@e-umt.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Munseok Kook
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UMT
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UMT
Facility Name
Kangbuk Samsung Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UMT
Facility Name
Kim's Eye Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UMT
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UMT
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UMT
Facility Name
Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UMT
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UMT

12. IPD Sharing Statement

Learn more about this trial

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

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