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)

Conditions: Dry Eye

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.

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

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; 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 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; 1. be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; 2. have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study; 3. have previously had laser-assisted in situ keratomileusis (lasik) surgery within the last 12 months; 4. have used restasis®, xiidra®, or cequa®, eysuvis™ and tyrvaya™ within 60 days of visit 1; 5. 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; 6. be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of visit 1; 7. 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 8. have an uncontrolled systemic disease; 9. be a woman who is pregnant, nursing, or planning a pregnancy; 10. 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); 11. 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; 12. have a known allergy and/or sensitivity to the test article or its components; 13. 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; 14. be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of visit 1; 15. be unable or unwilling to follow instructions, including participation in all study assessments and visits.