Normal Tension GlaucomaPhase 4NOPAPSNCT05279716
Study in Prostaglandin Associated Peri-orbitopathy Switching From Prostaglandin Monotherapy to Omidenepag Isopropyl
A Phase 4 study testing Eybelis ophthalmic solution 0.002% in people with Normal Tension Glaucoma and Primary Open-angle Glaucoma, run by Santen Pharmaceutical Asia Pte. Ltd. at 8 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Normal Tension Glaucoma, Primary Open-angle Glaucoma, Glaucoma, Suspect
- What is being tested?
- Eybelis ophthalmic solution 0.002%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 15 Feb 2022to 20 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Upper eyelid ptosis
- Periorbital hyperpigmentation
- Ciliary hypertrichosis
- Those who have agreed in writing to participate in this clinical trial.
Who cannot join
- 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)
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- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites, 8 recruiting
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si
UMT
- Recruiting
Asan Medical Center
Seoul
UMT
- Recruiting
Kangbuk Samsung Hospital
Seoul
UMT
- Recruiting
Kim's Eye Hospital
Seoul
UMT
- Recruiting
Korea University Anam Hospital
Seoul
UMT
- Recruiting
Seoul National University Hospital
Seoul
UMT
- Recruiting
Seoul ST. Mary's Hospital
Seoul
UMT
- Recruiting
Severance Hospital
Seoul
UMT
About this study
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
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%.
Read the 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
- Normal Tension Glaucoma, Primary Open-angle Glaucoma, Glaucoma, Suspect, Ocular Hypertension
- Being tested
- Eybelis ophthalmic solution 0.002%
- Keywords
- prostaglandin associated peri-orbitopathy(PAPS)
- Medical subject headings
- Low Tension Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eybelis ophthalmic solution 0.002%Drug
Also called Omidenepag isopropyl ophthalmic solution
Ophthalmic eye drop
| Study group | Role | What they receive |
|---|---|---|
| omidenepag isopropyl 0.02mg | Experimental | Instill 1 drop of Eybelis ophthalmic solution 0.002% once a day into the affected eye. Receives: Drug: Eybelis ophthalmic solution 0.002% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 24 weeks
Secondary outcomes (11)
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.
Measured: 24 weeks
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;
Measured: 24 weeks
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;
Measured: 24 weeks
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.
Measured: 24 weeks
Changes in intraocular pressure (IOP)
second efficacy parameter in intraocular pressure at 24 weeks compared to baseline.
Measured: 24 weeks
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.
Measured: 24 weeks
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;
Measured: 24 weeks
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
Measured: 24 weeks
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;
Measured: 24 weeks
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.
Measured: 24 weeks
Expression rate, number and change of Central Corneal Thickness
-Central Cornea Thickness
After eye drop anesthesia, it is measured with an Ultrasonic Pachymeter(μm).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start15 Feb 2022
- Primary completion8 Dec 2022 (estimated)
- Study completion20 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Tension GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Asia Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Munseok Kook, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279716
- Sponsor's protocol ID
- NO-PAPS-Study
- Acronym
- NOPAPS
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05279716
- Acronym / sponsor ID
- NOPAPS / NO-PAPS-Study
- Conditions
- Normal Tension Glaucoma, Primary Open-angle Glaucoma, Glaucoma, Suspect, Ocular Hypertension
- Keywords
- prostaglandin associated peri-orbitopathy(PAPS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Santen Pharmaceutical Asia Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 8 Dec 2022 (estimated)
- Study completion
- 20 Nov 2023 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| omidenepag isopropyl 0.02mg | Experimental | Drug: Eybelis ophthalmic solution 0.002%Instill 1 drop of Eybelis ophthalmic solution 0.002% once a day into the affected eye. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Those who have agreed in writing to participate in this clinical trial.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eybelis ophthalmic solution 0.002%Also: Omidenepag isopropyl ophthalmic solutionOphthalmic eye drop | Drug | omidenepag isopropyl 0.02mg |
Primary outcome
Improvement rate of DUES(Deepening of Upper Eyelid Sulcus)
Time frame: 24 weeks
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;
11 secondary outcomes
Improvement rate of FLEB (Flattening of Lower Eyelid Bag)
Time frame: 24 weeks
Improvement rate of Upper eyelid ptosis in prostaglandin-associated peri-orbitopathy
Time frame: 24 weeks
Improvement rate of Periorbital hyperpigmentation in prostaglandin-associated peri-orbitopathy
Time frame: 24 weeks
Improvement rate of Ciliary hypertrichosis in prostaglandin-associated peri-orbitopathy
Time frame: 24 weeks
Changes in intraocular pressure (IOP)
Time frame: 24 weeks
Response rate of changes in intraocular pressure (IOP)
Time frame: 24 weeks
Expression rate, number and change of Conjunctival Hyperemia
Time frame: 24 weeks
Expression rate, number and change of Macular Edema
Time frame: 24 weeks
Expression rate, number and change of Cystoid Macular Edema
Time frame: 24 weeks
Expression rate, number and change of Endothelial Cell Count
Time frame: 24 weeks
Expression rate, number and change of Central Corneal Thickness
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Munseok Kook principal investigator
Asan Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eybelis ophthalmic solution 0.002% in people with Normal Tension Glaucoma and Primary Open-angle Glaucoma, run by Santen Pharmaceutical Asia Pte. Ltd. at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact UMT Director (010-3386-0603 ext. +82, csyu@e-umt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement rate of DUES(Deepening of Upper Eyelid Sulcus) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.