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)

NCT05467293 | Completed Phase 2 Results FDA Drug

• 1 other identifier: YPP10-001
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Total Corneal Fluorescein Staining

  Modified National Eye Institute Scale; 0-20: Higher is Worse

  Day 85

• Ocular Discomfort Score

  Visual Analogue Scale; 0-100: Higher is Worse

  Day 85

Secondary Outcomes (38)

• Fluorescein Staining: Inferior

  13 weeks

• Fluorescein Staining: Superior

  13 weeks

• Fluorescein Staining: Central

  13 weeks

• Fluorescein Staining: Temporal

  13 weeks

• Fluorescein Staining: Nasal

  13 weeks

Study Arms (3)

0.3% YP-P10 Ophthalmic Solution

ACTIVE COMPARATOR

Drug: 0.3% YP-P10 Ophthalmic Solution

1% YP-P10 Ophthalmic Solution

ACTIVE COMPARATOR

Drug: 1% YP-P10 Ophthalmic Solution

YP-P10 Placebo Ophthalmic Solution (vehicle)

PLACEBO COMPARATOR

Drug: YP-P10 Placebo Ophthalmic Solution (vehicle)

Interventions

0.3% YP-P10 Ophthalmic Solution DRUG

Drug: YP-P10 Ophthalmic Solution

0.3% YP-P10 Ophthalmic Solution

1% YP-P10 Ophthalmic Solution DRUG

Drug: YP-P10 Ophthalmic Solution

1% YP-P10 Ophthalmic Solution

YP-P10 Placebo Ophthalmic Solution (vehicle) DRUG

Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

YP-P10 Placebo Ophthalmic Solution (vehicle)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals eligible to participate in this study must meet all of the following criteria: 0. Be at least 18 years of age;
• Provide written informed consent;
• Be willing and able to comply with all study procedures;
• Have a patient-reported history of dry eye for at least 6 months prior to Visit 1;
• Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;
• 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;
• 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;
• 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;
• 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;
• 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®;
• 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);
• Have at least one eye, the same eye, satisfy all criteria for 8, 9, 10 and 11 above;
• 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.)

You may not qualify if:

• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• Have used Restasis®, Xiidra®, or Cequa®, Eysuvis™ and Tyrvaya™ within 60 days of Visit 1;
• 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;
• Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;
• 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
• 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
• Corticosteroids or mast cell stabilizers (including ocular): 14 days prior to Visit 1
• 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
• All other topical ophthalmic preparations (including artificial tear substitutes) other than the study drops: 72 hours prior to Visit 1
• Have an uncontrolled systemic disease;
• Be a woman who is pregnant, nursing, or planning a pregnancy;
• 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);

Sponsors & Collaborators

• Yuyu Pharma, Inc.: lead

Study Sites (7)

Cornea Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Aesthetic Eye Care Institute

Newport Beach, California, 92663, United States

Location

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

NC Eye Associates

Apex, North Carolina, 27502, United States

Location

Oculus Research

Garner, North Carolina, 27529, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Robert Wonsang Yu
• Organization: Yuyu Pharma, Inc.

wsyu@yuyu.co.kr

+82 2 6972 9062

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Before the initiation of study run-in at Visit 1, each subject who provides written informed consent will be assigned a screening number. All screening numbers will be assigned in strict numerical sequence at a site and no numbers will skipped or omitted. Each subject who meets all the inclusion and none of the exclusion criteria at Visit 1 and Visit 2 will be assigned a randomization number at the end of Visit 2. The Interactive Web Response System (IWRS) will be used to assign all randomization numbers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multicenter, randomized, double-masked, placebo-controlled clinical study. Subjects will be randomized to one of the following treatment arms at Visit 2 (Day 1): * 0.3% YP-P10 Ophthalmic Solution: 1 drop BID in each eye (N = \~80) * 1% YP-P10 Ophthalmic Solution: 1 drop BID in each eye (N = \~80) * YP-P10 Placebo Ophthalmic Solution (vehicle): 1 drop BID in each eye (N = \~80)

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 20, 2022
• Study Start: June 27, 2022
• Primary Completion: March 6, 2023
• Study Completion: March 6, 2023
• Last Updated: July 30, 2024
• Results First Posted: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)