| Eligibility |
Inclusion Criteria:
1. Able to understand the key components of the study as described in the written ICF,
and willing and able to provide written informed consent.
2. Male or female = 18 years of age.
3. Clinical diagnosis of:
- Dry eye disease with episodes of eye discomfort in at least 4 of the previous 28
days during medical history assessment at Screening Visit, and have intensity >40
mm on a VAS scale at Screening (Day -28) visit OR
- Asthenopia with episodes of eye discomfort in at least 4 of previous 28 days
during medical assessment at Screening Visit and have intensity > 40 mm on a VAS
scale at Screening (Day -28) visit. The cause of asthenopia should be recorded.
4. Willing and able to comply with the study requirements including prohibited
concomitant medication restrictions.
5. Agree not to participate in another interventional study while on treatment.
6. If female, is surgically sterile or 2 years postmenopausal. Women of childbearing
potential may be enrolled if a urine pregnancy test is negative at Screening and at
Baseline Visits. Women of childbearing potential and men with partners who are of
childbearing potential must agree to use highly effective methods of contraception
from Screening throughout the study. Contraception use must continue for 90 days after
the last administration of the study drug. Examples of acceptable methods of
contraception which must be used together are described in Section 14.
7. If male, agrees to use a medically accepted highly effective method of contraception,
agrees to use this method for 90 days after last administration of the study drug, and
agrees to not donate sperm for 90 days after last administration of the study drug
8. Agree not to change lifestyle significantly during this study (Day -28 to Day 28).
Exclusion Criteria:
1. Active ocular infection or ocular inflammatory disease other than dry eye disease
2. Presence of anterior membrane dystrophy or history of clinically significant recurrent
erosion syndrome.
3. Significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal,
hepatic, gastrointestinal, or neurologic disease.
4. Prior radial keratotomy at any time or prior laser refractive surgery within the past
12 months of Screening Visit.
5. Unable to discontinue any over the counter (OTC), herbal, or systemic administration
(including transdermal applications) of opioids or treatments for neuropathic pain
(e.g., gabapentin or pregabalin, tetrahydrocannabinol) during the study on Days -28 to
+28.
6. Seated blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic).
7. History (within the past 30 days) or currently taking strong or moderate cytochrome
P450 3A4 (CYP3A4) inhibitors (e.g., itraconazole, ketoconazole, fluconazole;
erythromycin, clarithromycin, telithromycin; diltiazem, verapamil; aprepitant,
cyclosporine, grapefruit juice, and HIV protease inhibitors), strong or moderate
CYP3A4 inducers (e.g., barbiturates, primidone, mitotane, enzalutamide, efavirenz,
apalutamide, carbamazepine, phenytoin, rifampin, , and St. John's wort), inhibitors of
the BCRP (breast cancer resistance protein) transporter (e.g., curcumin and
eltrombopag), and/or P-gp inhibitors (e.g., clarithromycin, quinidine, and
cyclosporine), or drugs with narrow therapeutic margins (e.g., digoxin, warfarin). For
a more complete list see FDA
https://www.fda.gov/drugs/drug-interactions-labeling/drug- development
and-drug-interactions-table-substrates-inhibitors-and-inducers#table5-2 (August 24,
2022).
8. Pregnant or plans to become pregnant and/or patients who are breastfeeding or plan to
breastfeed during the study.
9. Current malignancy or a history of malignancy (within the past 5 years), except non
metastatic basal or squamous cell carcinoma of the skin that has been treated
successfully.
10. Significant liver disease, defined as having elevated aspartate aminotransferase (AST)
and/or alanine aminotransferase (ALT) levels greater than 1.5 times the upper value of
the normal range of the laboratory OR total bilirubin greater than 1.5 mg/dL (except
for patients with a diagnosis of Gilbert's disease) OR serum albumin less than 2.8
g/dL at Screening Visit.
11. History of any other acute or chronic medical condition or pre-planned
medical/surgical procedure that, in the opinion of the Investigator, would compromise
the safety of the patient or the integrity of study results.
12. History of acute hepatitis within 6 months of Screening Visit or chronic hepatitis
(including nonalcoholic steatohepatitis) or a positive result on anti-hepatitis A
immunoglobulin M (IgM) antibody, hepatitis B surface antigen, or anti-hepatitis C
antibody testing at Screening Visit.
13. Concurrent participation in another interventional study or treatment with an
investigational drug up to 30 days or 5 half-lives (depending on medication) prior to
Screening Visit.
14. Any form of substance abuse, psychiatric disorder, or a condition that, in the opinion
of the Investigator, could invalidate communication with the Investigator during the
study.
15. Positive test result for drugs of abuse at Screening Visit.
16. Unable to have a stable routine at home and workplace during the study.
17. The Principal Investigator reserves the right to declare a patient ineligible based on
medical evidence that indicates the patient is unsuitable for the study.
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