the study evaluating the efficacy and safety of ok-101 in subjects with dry eye disease

Conditions: Dry Eye Disease

Summary: the objective of this study is to compare the safety and efficacy of ok-101 ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye.

subjects eligible to be randomized will receive either ok-101 or placebo to be administered bilaterally twice daily (bid) for 12 weeks (from visit 2 to visit 5). during a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive placebo ophthalmic solution (vehicle) bilaterally bid.

Eligibility criteria:
inclusion criteria: 1. be at least 18 years of age; 2. provide written informed consent; 3. be willing and able to comply with all study procedures; 4. have a patient-reported history of dry eye for at least 6 months prior to visit 1; 5. have a history of use or desire to use eye drops for dry eye symptoms within 6 months of visit 1; 6. 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; 7. report a score of ≥ 2 according to the ora calibra® ocular discomfort \& 4-symptom questionnaire in at least one of the dry eye symptoms at visits 1 and 2; 8. have a schirmer's test score of ≤ 10 mm and ≥ 1 mm at visits 1 and 2; 9. have a corneal fluorescein staining score of ≥ 2 in at least one region 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; 10. have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal and nasal regions pre-cae® at visits 1 and 2; 11. 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; 12. demonstrate in the same eye(s) a response to the cae at visits 1 and 2 as defined by: 1. having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following cae® exposure; 2. 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); 13. have at least one eye, the same eye, satisfy all criteria for 8, 9, 10, 11 and 12 above; 14. 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: 1. have any clinically significant slit lamp findings at visit 1 that may include active blepharitis, meibomian gland dysfunction, ocular rosacea, lid margin inflammation, or active ocular allergies that require therapeutic treatment, or currently using tetracyclines (e.g., doxycycline, minocycline, tetracycline) and/or in the opinion of the investigator may interfere with study parameters; 2. be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at visit 1; 3. have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses during the study; 4. have previously had laser-assisted in situ keratomileusis (lasik) surgery, photorefractive keratectomy (prk), or small incision lenticule extraction (smile) within the last 12 months; 5. have used restasis®, xiidra®, cequa®, tyrvaya®, serum tears, generic cyclosporine a, and eysuvis® within 30 days of visit 1; 6. 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; 7. any use of lipiflow, thermopulsation, meibomian gland expression or intense pulsed light treatment within 6 months of visit 1 8. be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of visit 1 or have permanent punctal plugs or had surgical punctal occlusion; 9. 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: 1. antihistamines (including ocular): 72 hours prior to visit 1 2. 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 3. corticosteroids or mast cell stabilizers (including ocular): 14 days prior to visit 1 4. 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 5. neurostimulators: 30 days prior to visit 1 6. current use or planned use of prokera® during study conduct or within 30 days prior to visit 1 7. all other topical ophthalmic preparations (including artificial tear substitutes) other than the study drops: 72 hours prior to visit 1 10. have an uncontrolled systemic disease; 11. be a woman who is pregnant, nursing, or planning a pregnancy; 12. 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 postmenopausal (without menses for 12 consecutive months); 13. 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; 14. have a known allergy and/or sensitivity to the test article or its components; 15. 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; 16. be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of visit 1;