Dry Eye
Conditions
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
Interventions
DRUG0.3% YP-P10 Ophthalmic Solution
Drug: YP-P10 Ophthalmic Solution
DRUG1% YP-P10 Ophthalmic Solution
Drug: YP-P10 Ophthalmic Solution
DRUGYP-P10 Placebo Ophthalmic Solution (vehicle)
Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
Sponsors
Yuyu Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Corneal Fluorescein Staining | Day 85 | Modified National Eye Institute Scale; 0-20: Higher is Worse |
| Ocular Discomfort Score | Day 85 | Visual Analogue Scale; 0-100: Higher is Worse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescein Staining: Superior | 13 weeks | Modified National Eye Institute Scale; 0-4: Higher is Worse |
| Fluorescein Staining: Central | 13 weeks | Modified National Eye Institute Scale; 0-4: Higher is Worse |
| Fluorescein Staining: Temporal | 13 weeks | Modified National Eye Institute Scale; 0-4: Higher is Worse |
| Fluorescein Staining: Nasal | 13 weeks | Modified National Eye Institute Scale; 0-4: Higher is Worse |
| Lissamine Green Staining: Conjunctival Sum | 13 weeks | Modified National Eye Institute Scale; 0-24: Higher is Worse |
| Lissamine Green Staining: Inferior Temporal | 13 weeks | Modified National Eye Institute Scale; 0-4: Higher is Worse |
| Lissamine Green Staining: Superior Temporal | 13 weeks | Modified National Eye Institute Scale; 0-4 Higher is Worse |
| Lissamine Green Staining: Temporal | 13 weeks | Modified National Eye Institute Scale; 0-4 Higher is Worse |
| Lissamine Green Staining: Superior Nasal | 13 weeks | Modified National Eye Institute Scale; 0-4 Higher is Worse |
| Lissamine Green Staining: Nasal | 13 weeks | Modified National Eye Institute Scale; 0-4 Higher is Worse |
| Conjunctival Redness | 13 weeks | Ora Calibra Scale; 0-4 Higher is Worse |
| Unanesthetized Schirmer's Test | 13 weeks | 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. |
| Tear Film Break-up Time (TFBUT) | 13 weeks | — |
| Ocular Surface Disease Index (OSDI): Subtotal 1-5 | 13 weeks | Ocular Surface Disease Index Scale 0-100 (higher is worse) |
| Ocular Surface Disease Index (OSDI): Subtotal 6-9 | 13 weeks | Ocular Surface Disease Index Scale 0-100 (higher is worse) |
| Ocular Surface Disease Index (OSDI): Subtotal 10-12 | 13 weeks | Ocular Surface Disease Index Scale 0-100 (higher is worse) |
| Ocular Surface Disease Index (OSDI): Total | 13 weeks | Ocular Surface Disease Index Scale 0-100 (higher is worse) |
| Burning/Stinging | 13 weeks | Visual Analog Scale; 0-100: Higher is Worse |
| Lissamine Green Staining: Inferior Nasal | 13 weeks | Modified National Eye Institute Scale; 0-4 Higher is Worse |
| Foreign Body Sensation | 13 Weeks | Visual Analog Scale; 0-100: Higher is Worse |
| Blurred Vision | 13 Weeks | Visual Analog Scale; 0-100: Higher is Worse |
| Eye Dryness | 13 Weeks | Visual Analog Scale; 0-100: Higher is Worse |
| Photophobia | 13 Weeks | Visual Analog Scale; 0-100: Higher is Worse |
| Pain in Eyes | 13 Weeks | Visual Analog Scale; 0-100: Higher is Worse |
| Treatment Compliance Using a Daily Compliance Diary | 13 weeks | 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 \[(Date of Last Dose - Date of First Dose) + 1\] |
| Drop Comfort - Positive Response | 13 weeks | 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 |
| Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR | 13 weeks | Visual Acuity was assessed using an ETDRS chart |
| Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS | 13 weeks | Slit lamp biomicroscopic observations will be graded as Normal or Abnormal |
| Adverse Event Query - TEAEs | 13 weeks | Each subject will be queried regarding adverse events |
| Adverse Event Query - Ocular TEAEs | 13 Weeks | Each subject will be queried regarding adverse events |
| Adverse Event Query - Non Ocular TEAEs | 13 Weeks | Each subject will be queried regarding adverse events |
| Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation | 13 Weeks | Each subject will be queried regarding adverse events |
| Adverse Event Query - TEAEs Suspected to be Related to Study Drug | 13 Weeks | Each subject will be queried regarding adverse events |
| Adverse Event Query - SEA Reported | 13 Weeks | Each subject will be queried regarding adverse events |
| Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS | 13 weeks | using indirect ophthalmoscopy. The Investigator will make observations of the vitreous, retina, macula, choroid and optic nerve. |
| Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges | 13 weeks | A single measurement is made |
| Itching | 13 weeks | Visual Analog Scale; 0-100: Higher is Worse |
| Fluorescein Staining: Inferior | 13 weeks | Modified National Eye Institute Scale; 0-4: Higher is Worse |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.3% YP-P10 Ophthalmic Solution 0.3% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution | 85 |
| 1% YP-P10 Ophthalmic Solution 1% YP-P10 Ophthalmic Solution: Drug: YP-P10 Ophthalmic Solution | 86 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) YP-P10 Placebo Ophthalmic Solution (vehicle): Placebo YP-P10 Placebo Ophthalmic Solution (vehicle) | 86 |
| Total | 257 |
Baseline characteristics
| Characteristic | 0.3% YP-P10 Ophthalmic Solution | 1% YP-P10 Ophthalmic Solution | YP-P10 Placebo Ophthalmic Solution (Vehicle) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | NA Participants | NA Participants | NA Participants | NA Participants |
| Age, Categorical >=65 years | 39 Participants | 35 Participants | 38 Participants | 112 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants | 51 Participants | 48 Participants | 145 Participants |
| Ethnicity Hispanic or Latino | 13 Participants | 9 Participants | 11 Participants | 33 Participants |
| Ethnicity Not Hispanic or Latino | 72 Participants | 77 Participants | 75 Participants | 224 Participants |
| Iris Color (OD) Black | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Iris Color (OD) Blue | 8 Participants | 13 Participants | 11 Participants | 32 Participants |
| Iris Color (OD) Brown | 59 Participants | 55 Participants | 54 Participants | 168 Participants |
| Iris Color (OD) Gray | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Iris Color (OD) Green | 7 Participants | 8 Participants | 9 Participants | 24 Participants |
| Iris Color (OD) Hazel | 8 Participants | 8 Participants | 10 Participants | 26 Participants |
| Iris Color (OD) Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Iris Color (OS) Black | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Iris Color (OS) Blue | 8 Participants | 13 Participants | 11 Participants | 32 Participants |
| Iris Color (OS) Brown | 59 Participants | 55 Participants | 54 Participants | 168 Participants |
| Iris Color (OS) Gray | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Iris Color (OS) Green | 7 Participants | 8 Participants | 9 Participants | 24 Participants |
| Iris Color (OS) Hazel | 8 Participants | 8 Participants | 10 Participants | 26 Participants |
| Iris Color (OS) Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 16 Participants | 17 Participants | 17 Participants | 50 Participants |
| Race/Ethnicity, Customized Black or African American | 23 Participants | 17 Participants | 14 Participants | 54 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 44 Participants | 50 Participants | 52 Participants | 146 Participants |
| Region of Enrollment United States | 85 participants | 86 participants | 86 participants | 257 participants |
| Sex: Female, Male Female | 72 Participants | 59 Participants | 61 Participants | 192 Participants |
| Sex: Female, Male Male | 13 Participants | 27 Participants | 25 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 86 | 0 / 85 | 0 / 86 |
| other Total, other adverse events | 28 / 86 | 34 / 85 | 42 / 86 |
| serious Total, serious adverse events | 1 / 86 | 0 / 85 | 1 / 86 |
Outcome results
Primary
Ocular Discomfort Score
Visual Analogue Scale; 0-100: Higher is Worse
Time frame: Day 85
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Ocular Discomfort Score | 52.8 score on a scale | Standard Deviation 24.77 |
| 0.3% YP-P10 Ophthalmic Solution | Ocular Discomfort Score | 54.2 score on a scale | Standard Deviation 27.17 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Ocular Discomfort Score | 53.6 score on a scale | Standard Deviation 26.4 |
Primary
Total Corneal Fluorescein Staining
Modified National Eye Institute Scale; 0-20: Higher is Worse
Time frame: Day 85
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Total Corneal Fluorescein Staining | 7.35 score on a scale | Standard Deviation 1.73 |
| 0.3% YP-P10 Ophthalmic Solution | Total Corneal Fluorescein Staining | 7.25 score on a scale | Standard Deviation 1.957 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Total Corneal Fluorescein Staining | 7.12 score on a scale | Standard Deviation 1.85 |
Secondary
Adverse Event Query - Non Ocular TEAEs
Each subject will be queried regarding adverse events
Time frame: 13 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Adverse Event Query - Non Ocular TEAEs | 11 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Adverse Event Query - Non Ocular TEAEs | 13 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Adverse Event Query - Non Ocular TEAEs | 18 Participants |
Secondary
Adverse Event Query - Ocular TEAEs
Each subject will be queried regarding adverse events
Time frame: 13 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Adverse Event Query - Ocular TEAEs | 12 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Adverse Event Query - Ocular TEAEs | 13 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Adverse Event Query - Ocular TEAEs | 17 Participants |
Secondary
Adverse Event Query - SEA Reported
Each subject will be queried regarding adverse events
Time frame: 13 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Adverse Event Query - SEA Reported | 1 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Adverse Event Query - SEA Reported | 0 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Adverse Event Query - SEA Reported | 1 Participants |
Secondary
Adverse Event Query - TEAEs
Each subject will be queried regarding adverse events
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs | 21 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs | 24 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Adverse Event Query - TEAEs | 31 Participants |
Secondary
Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation
Each subject will be queried regarding adverse events
Time frame: 13 Weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation | 3 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation | 2 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation | 1 Participants |
Secondary
Adverse Event Query - TEAEs Suspected to be Related to Study Drug
Each subject will be queried regarding adverse events
Time frame: 13 Weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | Definitely related to study drug | 8 Participants |
| 1% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | Probably related to study drug | 2 Participants |
| 1% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | Possibly related to study drug | 1 Participants |
| 1% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | No TEAE Reported | 75 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | No TEAE Reported | 77 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | Definitely related to study drug | 5 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | Possibly related to study drug | 2 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | Probably related to study drug | 1 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | No TEAE Reported | 73 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | Probably related to study drug | 4 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | Possibly related to study drug | 4 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Adverse Event Query - TEAEs Suspected to be Related to Study Drug | Definitely related to study drug | 5 Participants |
Secondary
Blurred Vision
Visual Analog Scale; 0-100: Higher is Worse
Time frame: 13 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Blurred Vision | 41.2 score on a scale | Standard Deviation 27.9 |
| 0.3% YP-P10 Ophthalmic Solution | Blurred Vision | 45.0 score on a scale | Standard Deviation 28.89 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Blurred Vision | 41.5 score on a scale | Standard Deviation 26.62 |
Secondary
Burning/Stinging
Visual Analog Scale; 0-100: Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Burning/Stinging | 34.5 score on a scale | Standard Deviation 25.56 |
| 0.3% YP-P10 Ophthalmic Solution | Burning/Stinging | 37.9 score on a scale | Standard Deviation 28.33 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Burning/Stinging | 43.3 score on a scale | Standard Deviation 26.48 |
Secondary
Conjunctival Redness
Ora Calibra Scale; 0-4 Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Conjunctival Redness | 1.87 score on a scale | Standard Deviation 0.619 |
| 0.3% YP-P10 Ophthalmic Solution | Conjunctival Redness | 1.87 score on a scale | Standard Deviation 0.655 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Conjunctival Redness | 1.94 score on a scale | Standard Deviation 0.639 |
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.
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS | 0 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS | 0 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS | 0 Participants |
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
Time frame: 13 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Drop Comfort - Positive Response | 89.5 percentage of comfort |
| 0.3% YP-P10 Ophthalmic Solution | Drop Comfort - Positive Response | 84.7 percentage of comfort |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Drop Comfort - Positive Response | 84.9 percentage of comfort |
Secondary
Eye Dryness
Visual Analog Scale; 0-100: Higher is Worse
Time frame: 13 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Eye Dryness | 61.2 score on a scale | Standard Deviation 24.5 |
| 0.3% YP-P10 Ophthalmic Solution | Eye Dryness | 65.3 score on a scale | Standard Deviation 23.51 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Eye Dryness | 60.4 score on a scale | Standard Deviation 23.42 |
Secondary
Fluorescein Staining: Central
Modified National Eye Institute Scale; 0-4: Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Fluorescein Staining: Central | 1.33 score on a scale | Standard Deviation 0.535 |
| 0.3% YP-P10 Ophthalmic Solution | Fluorescein Staining: Central | 1.28 score on a scale | Standard Deviation 0.543 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining: Central | 1.29 score on a scale | Standard Deviation 0.545 |
Secondary
Fluorescein Staining: Inferior
Modified National Eye Institute Scale; 0-4: Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Fluorescein Staining: Inferior | 1.71 score on a scale | Standard Deviation 0.379 |
| 0.3% YP-P10 Ophthalmic Solution | Fluorescein Staining: Inferior | 1.71 score on a scale | Standard Deviation 0.471 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining: Inferior | 1.73 score on a scale | Standard Deviation 0.507 |
Secondary
Fluorescein Staining: Nasal
Modified National Eye Institute Scale; 0-4: Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Fluorescein Staining: Nasal | 1.60 score on a scale | Standard Deviation 0.548 |
| 0.3% YP-P10 Ophthalmic Solution | Fluorescein Staining: Nasal | 1.57 score on a scale | Standard Deviation 0.655 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining: Nasal | 1.55 score on a scale | Standard Deviation 0.542 |
Secondary
Fluorescein Staining: Superior
Modified National Eye Institute Scale; 0-4: Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Fluorescein Staining: Superior | 1.34 score on a scale | Standard Deviation 0.516 |
| 0.3% YP-P10 Ophthalmic Solution | Fluorescein Staining: Superior | 1.36 score on a scale | Standard Deviation 0.537 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining: Superior | 1.26 score on a scale | Standard Deviation 0.519 |
Secondary
Fluorescein Staining: Temporal
Modified National Eye Institute Scale; 0-4: Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Fluorescein Staining: Temporal | 1.36 score on a scale | Standard Deviation 0.501 |
| 0.3% YP-P10 Ophthalmic Solution | Fluorescein Staining: Temporal | 1.33 score on a scale | Standard Deviation 0.57 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Fluorescein Staining: Temporal | 1.29 score on a scale | Standard Deviation 0.444 |
Secondary
Foreign Body Sensation
Visual Analog Scale; 0-100: Higher is Worse
Time frame: 13 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Foreign Body Sensation | 38.8 score on a scale | Standard Deviation 27.62 |
| 0.3% YP-P10 Ophthalmic Solution | Foreign Body Sensation | 40.2 score on a scale | Standard Deviation 28.63 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Foreign Body Sensation | 40.6 score on a scale | Standard Deviation 28.46 |
Secondary
Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges
A single measurement is made
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges | 0 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges | 0 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges | 0 Participants |
Secondary
Itching
Visual Analog Scale; 0-100: Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Itching | 38.5 score on a scale | Standard Deviation 25.05 |
| 0.3% YP-P10 Ophthalmic Solution | Itching | 44.2 score on a scale | Standard Deviation 28.09 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Itching | 40.9 score on a scale | Standard Deviation 25.5 |
Secondary
Lissamine Green Staining: Conjunctival Sum
Modified National Eye Institute Scale; 0-24: Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Conjunctival Sum | 5.36 score on a scale | Standard Deviation 3.922 |
| 0.3% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Conjunctival Sum | 4.96 score on a scale | Standard Deviation 3.872 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining: Conjunctival Sum | 5.62 score on a scale | Standard Deviation 3.848 |
Secondary
Lissamine Green Staining: Inferior Nasal
Modified National Eye Institute Scale; 0-4 Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Inferior Nasal | 0.92 score on a scale | Standard Deviation 0.751 |
| 0.3% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Inferior Nasal | 0.94 score on a scale | Standard Deviation 0.775 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining: Inferior Nasal | 1.11 score on a scale | Standard Deviation 0.733 |
Secondary
Lissamine Green Staining: Inferior Temporal
Modified National Eye Institute Scale; 0-4: Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Inferior Temporal | 0.83 score on a scale | Standard Deviation 0.754 |
| 0.3% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Inferior Temporal | 0.76 score on a scale | Standard Deviation 0.68 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining: Inferior Temporal | 0.95 score on a scale | Standard Deviation 0.695 |
Secondary
Lissamine Green Staining: Nasal
Modified National Eye Institute Scale; 0-4 Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Nasal | 1.04 score on a scale | Standard Deviation 0.862 |
| 0.3% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Nasal | 0.93 score on a scale | Standard Deviation 0.81 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining: Nasal | 0.99 score on a scale | Standard Deviation 0.799 |
Secondary
Lissamine Green Staining: Superior Nasal
Modified National Eye Institute Scale; 0-4 Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Superior Nasal | 0.94 score on a scale | Standard Deviation 0.799 |
| 0.3% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Superior Nasal | 0.86 score on a scale | Standard Deviation 0.83 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining: Superior Nasal | 0.88 score on a scale | Standard Deviation 0.818 |
Secondary
Lissamine Green Staining: Superior Temporal
Modified National Eye Institute Scale; 0-4 Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Superior Temporal | 0.76 score on a scale | Standard Deviation 0.689 |
| 0.3% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Superior Temporal | 0.66 score on a scale | Standard Deviation 0.7 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining: Superior Temporal | 0.76 score on a scale | Standard Deviation 0.723 |
Secondary
Lissamine Green Staining: Temporal
Modified National Eye Institute Scale; 0-4 Higher is Worse
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Temporal | 0.88 score on a scale | Standard Deviation 0.747 |
| 0.3% YP-P10 Ophthalmic Solution | Lissamine Green Staining: Temporal | 0.81 score on a scale | Standard Deviation 0.802 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Lissamine Green Staining: Temporal | 0.93 score on a scale | Standard Deviation 0.76 |
Secondary
Ocular Surface Disease Index (OSDI): Subtotal 10-12
Ocular Surface Disease Index Scale 0-100 (higher is worse)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Ocular Surface Disease Index (OSDI): Subtotal 10-12 | 55.86 score on a scale | Standard Deviation 27.538 |
| 0.3% YP-P10 Ophthalmic Solution | Ocular Surface Disease Index (OSDI): Subtotal 10-12 | 49.26 score on a scale | Standard Deviation 27.346 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Ocular Surface Disease Index (OSDI): Subtotal 10-12 | 55.53 score on a scale | Standard Deviation 26.114 |
Secondary
Ocular Surface Disease Index (OSDI): Subtotal 1-5
Ocular Surface Disease Index Scale 0-100 (higher is worse)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Ocular Surface Disease Index (OSDI): Subtotal 1-5 | 37.44 score on a scale | Standard Deviation 19.804 |
| 0.3% YP-P10 Ophthalmic Solution | Ocular Surface Disease Index (OSDI): Subtotal 1-5 | 37.71 score on a scale | Standard Deviation 21.555 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Ocular Surface Disease Index (OSDI): Subtotal 1-5 | 37.50 score on a scale | Standard Deviation 17.485 |
Secondary
Ocular Surface Disease Index (OSDI): Subtotal 6-9
Ocular Surface Disease Index Scale 0-100 (higher is worse)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Ocular Surface Disease Index (OSDI): Subtotal 6-9 | 39.29 score on a scale | Standard Deviation 24.653 |
| 0.3% YP-P10 Ophthalmic Solution | Ocular Surface Disease Index (OSDI): Subtotal 6-9 | 40.34 score on a scale | Standard Deviation 27.58 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Ocular Surface Disease Index (OSDI): Subtotal 6-9 | 35.75 score on a scale | Standard Deviation 22.152 |
Secondary
Ocular Surface Disease Index (OSDI): Total
Ocular Surface Disease Index Scale 0-100 (higher is worse)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Ocular Surface Disease Index (OSDI): Total | 42.49 score on a scale | Standard Deviation 19.426 |
| 0.3% YP-P10 Ophthalmic Solution | Ocular Surface Disease Index (OSDI): Total | 41.46 score on a scale | Standard Deviation 20.031 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Ocular Surface Disease Index (OSDI): Total | 41.42 score on a scale | Standard Deviation 17.098 |
Secondary
Pain in Eyes
Visual Analog Scale; 0-100: Higher is Worse
Time frame: 13 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Pain in Eyes | 30.5 score on a scale | Standard Deviation 27.26 |
| 0.3% YP-P10 Ophthalmic Solution | Pain in Eyes | 28.2 score on a scale | Standard Deviation 25.64 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Pain in Eyes | 33.6 score on a scale | Standard Deviation 28.1 |
Secondary
Photophobia
Visual Analog Scale; 0-100: Higher is Worse
Time frame: 13 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Photophobia | 44.9 score on a scale | Standard Deviation 27.7 |
| 0.3% YP-P10 Ophthalmic Solution | Photophobia | 47.1 score on a scale | Standard Deviation 29.82 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Photophobia | 44.0 score on a scale | Standard Deviation 29.57 |
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
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS | 0 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS | 0 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS | 0 Participants |
Secondary
Tear Film Break-up Time (TFBUT)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Tear Film Break-up Time (TFBUT) | 2.598 seconds | Standard Deviation 0.8443 |
| 0.3% YP-P10 Ophthalmic Solution | Tear Film Break-up Time (TFBUT) | 2.540 seconds | Standard Deviation 0.9201 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Tear Film Break-up Time (TFBUT) | 2.441 seconds | Standard Deviation 0.8812 |
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 \[(Date of Last Dose - Date of First Dose) + 1\]
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Treatment Compliance Using a Daily Compliance Diary | 114.90 percentage of compliance | Standard Deviation 134.816 |
| 0.3% YP-P10 Ophthalmic Solution | Treatment Compliance Using a Daily Compliance Diary | 100.13 percentage of compliance | Standard Deviation 4.525 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Treatment Compliance Using a Daily Compliance Diary | 100.83 percentage of compliance | Standard Deviation 8.48 |
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.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Unanesthetized Schirmer's Test | 5.2 mm | Standard Deviation 2.82 |
| 0.3% YP-P10 Ophthalmic Solution | Unanesthetized Schirmer's Test | 5.0 mm | Standard Deviation 2.76 |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Unanesthetized Schirmer's Test | 4.7 mm | Standard Deviation 2.72 |
Secondary
Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR
Visual Acuity was assessed using an ETDRS chart
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% YP-P10 Ophthalmic Solution | Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR | 0 Participants |
| 0.3% YP-P10 Ophthalmic Solution | Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR | 0 Participants |
| YP-P10 Placebo Ophthalmic Solution (Vehicle) | Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR | 0 Participants |