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)

Yuyu Pharma, Inc.7 sites in 1 country257 target enrollmentJune 27, 2022

ConditionsDry Eye

InterventionsYP-P10 Placebo Ophthalmic Solution (vehicle)0.3% YP-P10 Ophthalmic Solution 1% YP-P10 Ophthalmic Solution

Drugs0.3% YP-P10 Ophthalmic Solution 1% YP-P10 Ophthalmic Solution YP-P10 Placebo Ophthalmic Solution (vehicle)

Overview

Phase: Phase 2
Intervention: YP-P10 Placebo Ophthalmic Solution (vehicle)
Conditions: Dry Eye
Sponsor: Yuyu Pharma, Inc.
Enrollment: 257
Locations: 7
Primary Endpoint: Total Corneal Fluorescein Staining
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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

Registry

clinicaltrials.gov

Start Date

June 27, 2022

End Date

March 6, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yuyu Pharma, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Individuals eligible to participate in this study must meet all of the following criteria:
•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;

Exclusion Criteria

•Individuals who meet any of the following exclusion criteria will not be eligible to participate in the study:
•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;
•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

Arms & Interventions

YP-P10 Placebo Ophthalmic Solution (vehicle)

Intervention: YP-P10 Placebo Ophthalmic Solution (vehicle)

0.3% YP-P10 Ophthalmic Solution

Intervention: 0.3% YP-P10 Ophthalmic Solution

1% YP-P10 Ophthalmic Solution

Intervention: 1% YP-P10 Ophthalmic Solution

Outcomes

Primary Outcomes

Total Corneal Fluorescein Staining

Time Frame: Day 85

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

Ocular Discomfort Score

Time Frame: Day 85

Visual Analogue Scale; 0-100: Higher is Worse

Secondary Outcomes

Lissamine Green Staining: Temporal(13 weeks)
Lissamine Green Staining: Inferior Nasal(13 weeks)
Lissamine Green Staining: Conjunctival Sum(13 weeks)
Ocular Surface Disease Index (OSDI): Subtotal 1-5(13 weeks)
Pain in Eyes(13 Weeks)
Fluorescein Staining: Nasal(13 weeks)
Conjunctival Redness(13 weeks)
Ocular Surface Disease Index (OSDI): Subtotal 6-9(13 weeks)
Ocular Surface Disease Index (OSDI): Subtotal 10-12(13 weeks)
Ocular Surface Disease Index (OSDI): Total(13 weeks)
Burning/Stinging(13 weeks)
Itching(13 weeks)
Foreign Body Sensation(13 Weeks)
Blurred Vision(13 Weeks)
Eye Dryness(13 Weeks)
Photophobia(13 Weeks)
Fluorescein Staining: Superior(13 weeks)
Fluorescein Staining: Central(13 weeks)
Fluorescein Staining: Inferior(13 weeks)
Fluorescein Staining: Temporal(13 weeks)
Lissamine Green Staining: Nasal(13 weeks)
Unanesthetized Schirmer's Test(13 weeks)
Tear Film Break-up Time (TFBUT)(13 weeks)
Lissamine Green Staining: Inferior Temporal(13 weeks)
Lissamine Green Staining: Superior Temporal(13 weeks)
Lissamine Green Staining: Superior Nasal(13 weeks)
Adverse Event Query - SEA Reported(13 Weeks)
Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS(13 weeks)
Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges(13 weeks)
Treatment Compliance Using a Daily Compliance Diary(13 weeks)
Drop Comfort - Positive Response(13 weeks)
Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR(13 weeks)
Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS(13 weeks)
Adverse Event Query - TEAEs(13 weeks)
Adverse Event Query - Ocular TEAEs(13 Weeks)
Adverse Event Query - Non Ocular TEAEs(13 Weeks)
Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation(13 Weeks)
Adverse Event Query - TEAEs Suspected to be Related to Study Drug(13 Weeks)