Dry EyePhase 2NCT05467293
Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)
A Phase 2 study testing 0.3% YP-P10 Ophthalmic Solution and 1% YP-P10 Ophthalmic Solution in people with Dry Eye, run by Yuyu Pharma, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dry Eye
- What is being tested?
- 0.3% YP-P10 Ophthalmic Solution and 1% YP-P10 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 257 participants
- Where
- 7 sitesUnited States
- Study dates
- 27 Jun 2022to 6 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Show all 14Show fewer
- 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.)
Who cannot join
- 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;
Show all 21Show fewer
- 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);
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Andover Eye Associates
Andover, Massachusetts, 01810
NC Eye Associates
Apex, North Carolina, 27502
Vision Institute
Colorado Springs, Colorado, 80907
Oculus Research
Garner, North Carolina, 27529
Total Eye Care
Memphis, Tennessee, 38119
Aesthetic Eye Care Institute
Newport Beach, California, 92663
Cornea Consultants of Arizona
Phoenix, Arizona, 85032
About this study
Official title: A Phase 2, Multi-center, Randomized, Double- Masked and Placebo-Controlled Study Evaluating the Efficacy and Safety of YP-P10 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye (ICECAP 1)
The objective of this study is to compare the safety and efficacy of YP-P10 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.
Read the 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
- Conditions
- Dry Eye
- Being tested
- 0.3% YP-P10 Ophthalmic Solution, 1% YP-P10 Ophthalmic Solution, YP-P10 Placebo Ophthalmic Solution (vehicle)
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% YP-P10 Ophthalmic SolutionDrug
Drug: YP-P10 Ophthalmic Solution
1% YP-P10 Ophthalmic SolutionDrug
Drug: YP-P10 Ophthalmic Solution
YP-P10 Placebo Ophthalmic Solution (vehicle)Drug
Placebo YP-P10 Placebo Ophthalmic Solution (vehicle)
| Study group | Role | What they receive |
|---|---|---|
| 0.3% YP-P10 Ophthalmic Solution | Active comparator | Not described Receives: Drug: 0.3% YP-P10 Ophthalmic Solution |
| 1% YP-P10 Ophthalmic Solution | Active comparator | Not described Receives: Drug: 1% YP-P10 Ophthalmic Solution |
| YP-P10 Placebo Ophthalmic Solution (vehicle) | Placebo comparator | Not described Receives: Drug: YP-P10 Placebo Ophthalmic Solution (vehicle) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Corneal Fluorescein Staining
Modified National Eye Institute Scale; 0-20: Higher is Worse
Measured: Day 85
Ocular Discomfort Score
Visual Analogue Scale; 0-100: Higher is Worse
Measured: Day 85
Secondary outcomes (38)
Fluorescein Staining: Inferior
Modified National Eye Institute Scale; 0-4: Higher is Worse
Measured: 13 weeks
Fluorescein Staining: Superior
Modified National Eye Institute Scale; 0-4: Higher is Worse
Measured: 13 weeks
Fluorescein Staining: Central
Modified National Eye Institute Scale; 0-4: Higher is Worse
Measured: 13 weeks
Fluorescein Staining: Temporal
Modified National Eye Institute Scale; 0-4: Higher is Worse
Measured: 13 weeks
Fluorescein Staining: Nasal
Modified National Eye Institute Scale; 0-4: Higher is Worse
Measured: 13 weeks
Lissamine Green Staining: Conjunctival Sum
Modified National Eye Institute Scale; 0-24: Higher is Worse
Measured: 13 weeks
Lissamine Green Staining: Inferior Temporal
Modified National Eye Institute Scale; 0-4: Higher is Worse
Measured: 13 weeks
Lissamine Green Staining: Superior Temporal
Modified National Eye Institute Scale; 0-4 Higher is Worse
Measured: 13 weeks
Lissamine Green Staining: Temporal
Modified National Eye Institute Scale; 0-4 Higher is Worse
Measured: 13 weeks
Lissamine Green Staining: Inferior Nasal
Modified National Eye Institute Scale; 0-4 Higher is Worse
Measured: 13 weeks
Lissamine Green Staining: Superior Nasal
Modified National Eye Institute Scale; 0-4 Higher is Worse
Measured: 13 weeks
Lissamine Green Staining: Nasal
Modified National Eye Institute Scale; 0-4 Higher is Worse
Measured: 13 weeks
Conjunctival Redness
Ora Calibra Scale; 0-4 Higher is Worse
Measured: 13 weeks
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.
Measured: 13 weeks
Tear Film Break-up Time (TFBUT)
Measured: 13 weeks
Ocular Surface Disease Index (OSDI): Subtotal 1-5
Ocular Surface Disease Index Scale 0-100 (higher is worse)
Measured: 13 weeks
Ocular Surface Disease Index (OSDI): Subtotal 6-9
Ocular Surface Disease Index Scale 0-100 (higher is worse)
Measured: 13 weeks
Ocular Surface Disease Index (OSDI): Subtotal 10-12
Ocular Surface Disease Index Scale 0-100 (higher is worse)
Measured: 13 weeks
Ocular Surface Disease Index (OSDI): Total
Ocular Surface Disease Index Scale 0-100 (higher is worse)
Measured: 13 weeks
Burning/Stinging
Visual Analog Scale; 0-100: Higher is Worse
Measured: 13 weeks
Itching
Visual Analog Scale; 0-100: Higher is Worse
Measured: 13 weeks
Foreign Body Sensation
Visual Analog Scale; 0-100: Higher is Worse
Measured: 13 Weeks
Blurred Vision
Visual Analog Scale; 0-100: Higher is Worse
Measured: 13 Weeks
Eye Dryness
Visual Analog Scale; 0-100: Higher is Worse
Measured: 13 Weeks
Photophobia
Visual Analog Scale; 0-100: Higher is Worse
Measured: 13 Weeks
Pain in Eyes
Visual Analog Scale; 0-100: Higher is Worse
Measured: 13 Weeks
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]
Measured: 13 weeks
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
Measured: 13 weeks
Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR
Visual Acuity was assessed using an ETDRS chart
Measured: 13 weeks
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
Measured: 13 weeks
Adverse Event Query - TEAEs
Each subject will be queried regarding adverse events
Measured: 13 weeks
Adverse Event Query - Ocular TEAEs
Each subject will be queried regarding adverse events
Measured: 13 Weeks
Adverse Event Query - Non Ocular TEAEs
Each subject will be queried regarding adverse events
Measured: 13 Weeks
Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation
Each subject will be queried regarding adverse events
Measured: 13 Weeks
Adverse Event Query - TEAEs Suspected to be Related to Study Drug
Each subject will be queried regarding adverse events
Measured: 13 Weeks
Adverse Event Query - SEA Reported
Each subject will be queried regarding adverse events
Measured: 13 Weeks
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.
Measured: 13 weeks
Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges
A single measurement is made
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start27 Jun 2022
- Primary completion6 Mar 2023
- Study completion6 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuyu Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467293
- Sponsor's protocol ID
- YPP10-001
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2022
- Last updated
- 30 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05467293
- Acronym / sponsor ID
- YPP10-001
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Yuyu Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 6 Mar 2023 (actual)
- First posted
- 20 Jul 2022 (actual)
- Results
- Posted 30 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.3% YP-P10 Ophthalmic SolutionDrug: YP-P10 Ophthalmic Solution | Drug | 0.3% YP-P10 Ophthalmic Solution |
| 1% YP-P10 Ophthalmic SolutionDrug: YP-P10 Ophthalmic Solution | Drug | 1% YP-P10 Ophthalmic Solution |
| YP-P10 Placebo Ophthalmic Solution (vehicle)Placebo YP-P10 Placebo Ophthalmic Solution (vehicle) | Drug | YP-P10 Placebo Ophthalmic Solution (vehicle) |
Primary outcome
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
38 secondary outcomes
Fluorescein Staining: Inferior
Time frame: 13 weeks
Fluorescein Staining: Superior
Time frame: 13 weeks
Fluorescein Staining: Central
Time frame: 13 weeks
Fluorescein Staining: Temporal
Time frame: 13 weeks
Fluorescein Staining: Nasal
Time frame: 13 weeks
Lissamine Green Staining: Conjunctival Sum
Time frame: 13 weeks
Lissamine Green Staining: Inferior Temporal
Time frame: 13 weeks
Lissamine Green Staining: Superior Temporal
Time frame: 13 weeks
Lissamine Green Staining: Temporal
Time frame: 13 weeks
Lissamine Green Staining: Inferior Nasal
Time frame: 13 weeks
Lissamine Green Staining: Superior Nasal
Time frame: 13 weeks
Lissamine Green Staining: Nasal
Time frame: 13 weeks
Conjunctival Redness
Time frame: 13 weeks
Unanesthetized Schirmer's Test
Time frame: 13 weeks
Tear Film Break-up Time (TFBUT)
Time frame: 13 weeks
Ocular Surface Disease Index (OSDI): Subtotal 1-5
Time frame: 13 weeks
Ocular Surface Disease Index (OSDI): Subtotal 6-9
Time frame: 13 weeks
Ocular Surface Disease Index (OSDI): Subtotal 10-12
Time frame: 13 weeks
Ocular Surface Disease Index (OSDI): Total
Time frame: 13 weeks
Burning/Stinging
Time frame: 13 weeks
Itching
Time frame: 13 weeks
Foreign Body Sensation
Time frame: 13 Weeks
Blurred Vision
Time frame: 13 Weeks
Eye Dryness
Time frame: 13 Weeks
Photophobia
Time frame: 13 Weeks
Pain in Eyes
Time frame: 13 Weeks
Treatment Compliance Using a Daily Compliance Diary
Time frame: 13 weeks
Drop Comfort - Positive Response
Time frame: 13 weeks
Visual Acuity - Subjects With Increase Greater Than 0.2 logMAR
Time frame: 13 weeks
Slit-lamp Evaluation Biomicroscopy - Subjects That Had a Shift From Normal/Abnormal NCS to Abnormal CS
Time frame: 13 weeks
Adverse Event Query - TEAEs
Time frame: 13 weeks
Adverse Event Query - Ocular TEAEs
Time frame: 13 Weeks
Adverse Event Query - Non Ocular TEAEs
Time frame: 13 Weeks
Adverse Event Query - TEAEs Causing Premature Treatment Discontinuation
Time frame: 13 Weeks
Adverse Event Query - TEAEs Suspected to be Related to Study Drug
Time frame: 13 Weeks
Adverse Event Query - SEA Reported
Time frame: 13 Weeks
Dilated Fundoscopy: Shift From Normal/Abnormal NCS to Abnormal CS
Time frame: 13 weeks
Intraocular Pressure (IOP) by Contact Tonometry by the Examiner: Unsafe and Abnormal Ranges
Time frame: 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.3% YP-P10 Ophthalmic Solution and 1% YP-P10 Ophthalmic Solution in people with Dry Eye, run by Yuyu Pharma, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Corneal Fluorescein Staining (time frame: Day 85). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.