Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)

A Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)

The objective of this study is to compare the safety and efficacy of YP-P10 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Study Overview

• Status: Active, not recruiting
• Conditions: Dry Eye
• Intervention / Treatment: Drug: 0.3% YP-P10 Ophthalmic Solution; Drug: 1% YP-P10 Ophthalmic Solution; Drug: YP-P10 Placebo Ophthalmic Solution (vehicle)

Detailed Description

The clinical hypotheses for this study is that 0.3% YP-P10 Ophthalmic Solution twice daily (BID) and 1.0% YP-P10 Ophthalmic Solution BID are superior to YP-P10 Placebo Ophthalmic Solution (vehicle) for the primary endpoints of signs and symptoms of dry eye, as follows:

• Sign: Total corneal fluorescein staining score of the study eye using the modified NEI grading scale, measured by mean change from baseline (Visit 2, Pre- Controlled Adverse Environment [CAE®]) to Visit 6
• Symptom: Ocular discomfort score of both eyes using the Visual Analog Scale (VAS) Ocular Discomfort Scale, measured by mean change from baseline (Visit 2, Pre-CAE®) to Visit 6

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Senior Vice President; Phone Number: 9481 978) 685-8900; Email: gousler@oraclinical.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cornea Consultants of Arizona
  • California
    • Newport Beach, California, United States, 92663
      • Aesthetic Eye Care Institute
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Vision Institute
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
  • North Carolina
    • Apex, North Carolina, United States, 27502
      • NC Eye Associates
    • Garner, North Carolina, United States, 27529
      • Oculus Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals eligible to participate in this study must meet all of the following criteria: 0. Be at least 18 years of age;

1. Provide written informed consent;
2. Be willing and able to comply with all study procedures;
3. Have a patient-reported history of dry eye for at least 6 months prior to Visit 1;
4. Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
5. Have a best corrected visual acuity (BCVA) of 0.7 logarithm of the minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1;
6. Have a score of ≥ 2 for both eyes according to the Ora Calibra® Ocular Discomfort & 4- Symptom Questionnaire in at least one of the dry eye symptoms at Visits 1 and 2;
7. Have an unanesthetized Schirmer's Test score of ≤ 10 mm/5 minutes and ≥ 1 mm/5 minutes in at least one eye at Visits 1 and 2;
8. Have a corneal fluorescein staining score of ≥ 2 according to the Ora Calibra® Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining in at least one region in one eye at Visits 1 and 2 and a central score ≥ 1 in the same eye;
9. Have a conjunctival redness score ≥ 1 according to the Ora Calibra® Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2 pre-CAE®;

10. Demonstrate in the same eye(s) a response to the CAE® at Visits 1 and 2 as defined by:

    • Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE® exposure; a. Reporting an Ocular Discomfort score ≥ 3 at 2 or more consecutive time points in at least one eye during CAE® exposure (if a subject has an Ocular Discomfort rating of 3 at time = 0 for an eye, s/he must report an Ocular Discomfort rating of 4 for two consecutive measurements for that eye). Note: a subject cannot have an Ocular Discomfort score of 4 at time = 0);
11. Have at least one eye, the same eye, satisfy all criteria for 8, 9, 10 and 11 above;
12. A negative urine pregnancy test if female of childbearing potential (those who are not surgically sterilized [bilateral tubal ligation, hysterectomy or bilateral oophorectomy] or post-menopausal [12 months after last menses]) and must use adequate birth control through the study period. For non-sexually active females, abstinence may be regarded as an adequate method of birth control.)

Exclusion Criteria:

• Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study: 0. Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;

1. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
2. Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
3. Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
4. Have used Restasis®, Xiidra®, or Cequa®, Eysuvis™ and Tyrvaya™ within 60 days of Visit 1;
5. Have had any ocular and/or lid surgeries in the past 6 months or have any planned ocular and/or lid surgeries over the study period;
6. Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;

7. Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study); the respective wash- out periods are required for the following medications:

   • Antihistamines (including ocular): 72 hours prior to Visit 1

     1. Oral aspirin or aspirin-containing products allowed if dose has been stable over past 30 days prior to Visit 1 and no change in dose is anticipated during the study period
     2. Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to Visit 1
     3. Any medication (oral or topical) known to cause ocular drying that has not been administered as a stable dose for at least 30 days prior to Visit 1 and during the study
     4. All other topical ophthalmic preparations (including artificial tear substitutes) other than the study drops: 72 hours prior to Visit 1
8. Have an uncontrolled systemic disease;
9. Be a woman who is pregnant, nursing, or planning a pregnancy;
10. Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 6 (or early termination visit) if of childbearing potential. Non- childbearing potential is defined as a woman who is permanently sterilized (e.g., has had a hysterectomy or tubal ligation), or is post- menopausal (without menses for 12 consecutive months);
11. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; intrauterine device; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study;
12. Have a known allergy and/or sensitivity to the test article or its components;
13. Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
14. Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
15. Be unable or unwilling to follow instructions, including participation in all study assessments and visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.3% YP-P10 Ophthalmic Solution	Drug: 0.3% YP-P10 Ophthalmic Solution; Drug: YP-P10 Ophthalmic Solution
Active Comparator: 1% YP-P10 Ophthalmic Solution	Drug: 1% YP-P10 Ophthalmic Solution; Drug: YP-P10 Ophthalmic Solution
Placebo Comparator: YP-P10 Placebo Ophthalmic Solution (vehicle)	Drug: YP-P10 Placebo Ophthalmic Solution (vehicle); Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total corneal fluorescein staining score of the study eye using the modified NEI scale	Sign	Day 85
Ocular discomfort score of both eyes using the VAS	Symptom	Day 85

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescein staining	by region and total staining of each eye	Up to 13 weeks
Lissamine green staining on the modified NEI scale	by region and total staining of each eye	Up to 13 weeks
Conjunctival redness	of each eye	Up to 13 weeks
Schirmer's Test	of each eye	Up to 13 weeks
Tear film break-up time (TFBUT)	of each eye	Up to 13 weeks
Ocular Surface Disease Index© (OSDI©)	of eye	Up to 13 weeks
Dryness as measured by visual analog scale (VAS)	Burning/stinging, Itching, Foreign body sensation, Blurred vision, Photophobia, Pain, Eye	Up to 13 weeks
Daily compliance diary	Verification of compliance	Up to 13 weeks
Drop comfort	A drop comfort evaluation will be performed immediately upon administration of study drug and then at 1, 2, and 3 minutes following initial dosing using the Ora Calibra Drop Comfort Scale	Up to 13 weeks
Visual acuity	assessed using an ETDRS chart	Up to 13 weeks
Slit-lamp evaluation Biomicroscopy	Slit lamp biomicroscopic observations will be graded as Normal or Abnormal	Up to 13 weeks
Adverse event query	Each subject will be queried regarding adverse events	Up to 13 weeks
Intraocular Pressure (IOP) by contact tonometry by the examiner	A single measurement is made	Up to 13 weeks
Dilated fundoscopy	using indirect ophthalmoscopy. The Investigator will make observations of the vitreous, retina, macula, choroid and optic nerve.	Up to 13 weeks

Collaborators and Investigators

• Sponsor: Yuyu Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2022
• Primary Completion (Estimated): August 1, 2023
• Study Completion (Estimated): August 1, 2023

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: YPP10-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No