Phase 2, Multi-center, Randomized, Double- Masked and Pla... | NCT05467293

Label	Type	Intervention Names
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)

Name	Type	Description	Arm Group Labels	Other Names
0.3% YP-P10 Ophthalmic Solution	Drug	Drug: YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Fluorescein Staining: Inferior	Modified National Eye Institute Scale; 0-4: Higher is Worse	13 weeks
Fluorescein Staining: Superior	Modified National Eye Institute Scale; 0-4: Higher is Worse

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• 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.)

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;

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
  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
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);
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;
Have a known allergy and/or sensitivity to the test article or its components;
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;
Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
Be unable or unwilling to follow instructions, including participation in all study assessments and visits.

Facility	Status	City	State	ZIP	Country	Contacts
Cornea Consultants of Arizona		Phoenix	Arizona	85032	United States
Aesthetic Eye Care Institute

ID	Title	Description
FG000	0.3% YP-P10 Ophthalmic Solution	Participants enrolled in 0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution group
FG001	1% YP-P10 Ophthalmic Solution	Participants enrolled in 1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution group

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 3, 2023	Feb 27, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Total Corneal Fluorescein Staining

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

Posted

Mean

Standard Deviation

score on a scale

Day 85

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG00086 OG00185 OG00286
Eyes	OG000

Title

Denominators

Categories

Title	Measurements
	OG0007.35± 1.730 OG0017.25± 1.957 OG0027.12± 1.850

Primary

Ocular Discomfort Score

Visual Analogue Scale; 0-100: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

Day 85

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Fluorescein Staining: Inferior

Modified National Eye Institute Scale; 0-4: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Fluorescein Staining: Superior

Modified National Eye Institute Scale; 0-4: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Fluorescein Staining: Central

Modified National Eye Institute Scale; 0-4: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Fluorescein Staining: Temporal

Modified National Eye Institute Scale; 0-4: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Fluorescein Staining: Nasal

Modified National Eye Institute Scale; 0-4: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Lissamine Green Staining: Conjunctival Sum

Modified National Eye Institute Scale; 0-24: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Lissamine Green Staining: Inferior Temporal

Modified National Eye Institute Scale; 0-4: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Lissamine Green Staining: Superior Temporal

Modified National Eye Institute Scale; 0-4 Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Lissamine Green Staining: Temporal

Modified National Eye Institute Scale; 0-4 Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Lissamine Green Staining: Inferior Nasal

Modified National Eye Institute Scale; 0-4 Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Lissamine Green Staining: Superior Nasal

Modified National Eye Institute Scale; 0-4 Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Lissamine Green Staining: Nasal

Modified National Eye Institute Scale; 0-4 Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Conjunctival Redness

Ora Calibra Scale; 0-4 Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Unanesthetized Schirmer's Test

score on a scale of ≤ 10 mm/5 minutes and ≥ 1 mm/5 minutes in at least one eye. Schirmer's test can be interpreted as follows: 0 to 5 mm: extremely dry eyes; 5 to 10 mm: moderately dry eyes; 10 to 15 mm: possible dry eyes; Longer than 15 mm: normal tear function.

Posted

Mean

Standard Deviation

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants

Secondary

Tear Film Break-up Time (TFBUT)

Posted

Mean

Standard Deviation

seconds

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Ocular Surface Disease Index (OSDI): Subtotal 1-5

Ocular Surface Disease Index Scale 0-100 (higher is worse)

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Ocular Surface Disease Index (OSDI): Subtotal 6-9

Ocular Surface Disease Index Scale 0-100 (higher is worse)

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Ocular Surface Disease Index (OSDI): Subtotal 10-12

Ocular Surface Disease Index Scale 0-100 (higher is worse)

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Ocular Surface Disease Index (OSDI): Total

Ocular Surface Disease Index Scale 0-100 (higher is worse)

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Burning/Stinging

Visual Analog Scale; 0-100: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Itching

Visual Analog Scale; 0-100: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Foreign Body Sensation

Visual Analog Scale; 0-100: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 Weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Blurred Vision

Visual Analog Scale; 0-100: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 Weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Eye Dryness

Visual Analog Scale; 0-100: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 Weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Photophobia

Visual Analog Scale; 0-100: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 Weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Pain in Eyes

Visual Analog Scale; 0-100: Higher is Worse

Posted

Mean

Standard Deviation

score on a scale

13 Weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Treatment Compliance Using a Daily Compliance Diary

Self-Administrating with use of Daily Compliance Diary. Subject daily diaries were collected at Visits 1 through 6, and the subject's used and unused study drug ampules were collected at Visit 3 through 6. Dosing compliance was based on the used and unused ampule count. If the subject was less than 80% or more than 125% compliant with dosing based on the expected number of used ampules, then the subject was deemed noncompliant and a dosing deviation was recorded.

Dosing compliance (% compliance) was assessed by calculating the number of actual doses received and comparing that to the number of expected doses as follows:

Compliance (%) = Number of Actual Doses Received / Number of Expected Doses x 100%

The number of expected doses that will be used for calculating compliance was calculated as:

2 x [(Date of Last Dose - Date of First Dose) + 1]

Posted

Mean

Standard Deviation

percentage of compliance

13 weeks

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)

Secondary

Drop Comfort - Positive Response

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

Posted

Median

Full Range

percentage of comfort

13 weeks

Eyes

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR

Visual Acuity was assessed using an ETDRS chart

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS

Slit lamp biomicroscopic observations will be graded as Normal or Abnormal

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Adverse Event Query - TEAEs

Each subject will be queried regarding adverse events

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Adverse Event Query - Ocular TEAEs

Each subject will be queried regarding adverse events

Posted

Count of Participants

Participants

13 Weeks

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Adverse Event Query - Non Ocular TEAEs

Each subject will be queried regarding adverse events

Posted

Count of Participants

Participants

13 Weeks

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation

Each subject will be queried regarding adverse events

Posted

Count of Participants

Participants

13 Weeks

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Adverse Event Query - TEAEs Suspected to be Related to Study Drug

Each subject will be queried regarding adverse events

Posted

Count of Participants

Participants

13 Weeks

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Adverse Event Query - SEA Reported

Each subject will be queried regarding adverse events

Posted

Count of Participants

Participants

13 Weeks

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS

using indirect ophthalmoscopy. The Investigator will make observations of the vitreous, retina, macula, choroid and optic nerve.

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Secondary

Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges

A single measurement is made

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
OG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Instillation Eye Pain	General disorders	Systematic Assessment	EG00010 events10 affected86 at risk EG0014 events4 affected85 at risk EG0029 events9 affected86 at risk
Visual acuity reduced	Eye disorders	Systematic Assessment	EG0001 events1 affected86 at risk EG0013 events3 affected85 at risk EG0020 events0 affected86 at risk
Conjunctival haemorrhage	Eye disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0022 events2 affected86 at risk
Acquired hypertrophy of the retinal pigment epithelium	Eye disorders	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0020 events0 affected86 at risk
Blindness	Eye disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Corneal infiltrates	Eye disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Diabetic retinopathy	Eye disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Eyelid myokymia	Eye disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Foreign body sensation in eyes	Eye disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Ocular discomfort	Eye disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Vision blurred	Eye disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Visual Impairment	Eye disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Hordeolum	Infections and infestations	Systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected85 at risk EG0021 events1 affected86 at risk
Conjunctivitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Conjunctival abrasion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Corneal abrasion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
COVID-19	Infections and infestations	Systematic Assessment	EG0001 events1 affected86 at risk EG0012 events2 affected85 at risk EG0023 events3 affected86 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected86 at risk EG0013 events3 affected85 at risk EG0022 events2 affected86 at risk
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0022 events2 affected86 at risk
Tooth abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Otitis media	Infections and infestations	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Periodontitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0020 events0 affected86 at risk
Viral upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected86 at risk EG0013 events3 affected85 at risk EG0021 events1 affected86 at risk
Skin laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0021 events1 affected86 at risk
Contision	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Ligament Sprain	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0020 events0 affected86 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Skin abrasion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Tendon rupture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0020 events0 affected86 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0021 events1 affected86 at risk
Bursitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Greater trochanteric pain syndrome	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0020 events0 affected86 at risk
Intravertebral disc degeneration	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Carpal tunnel syndrome	Nervous system disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Diabetic neuropathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0021 events1 affected86 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Dental caries	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Attention deficit hyperactivity disorder	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0020 events0 affected86 at risk
Post-traumatic stress disorder	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0020 events0 affected86 at risk
Respiratory, thoracic, and mediastinal disorders	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Oropharyngeal pain	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk
Keloid scar	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0020 events0 affected86 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0020 events0 affected86 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected86 at risk EG0011 events1 affected85 at risk EG0020 events0 affected86 at risk

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

ID	Title	Description
BG000	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
BG001	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution
BG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	1% YP-P10 Ophthalmic Solution	1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution	1	86	1	86	28	86
EG001	0.3% YP-P10 Ophthalmic Solution	0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution	0	85	0	85	34	85
EG002	YP-P10 Placebo Ophthalmic Solution (Vehicle)	YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)	0	86	1	86	42	86

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Serious Adverse Event	Cardiac disorders		Systematic Assessment	Cardiac arrest secondary to arteriosclerotic cardiovascular disease leading to death	EG0001 events1 affected86 at risk EG0010 events0 affected85 at risk EG0020 events0 affected86 at risk
Serious Adverse Event	General disorders		Systematic Assessment	Worsening of laceration in the right leg	EG0000 events0 affected86 at risk EG0010 events0 affected85 at risk EG0021 events1 affected86 at risk