CompletedNot Applicable

Evaluate the Safety and Efficacy of Calcitonin Gene-Related Peptide (CGRP) Antagonists in Patients With Dry Eye Disease and Asthenopia

United States103 participantsStarted 2023-05-10

Plain-language summary

Safety and Efficacy of Medications for Migraine in Patients with Dry Eye Disease or Asthenopia

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Able to understand the key components of the study as described in the written ICF, and willing and able to provide written informed consent.
✓. Male or female ≥ 18 years of age.
✓. Clinical diagnosis of:
✓. Willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
✓. Agree not to participate in another interventional study while on treatment.
✓. 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.
✓. 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
✓. Agree not to change lifestyle significantly during this study (Day -28 to Day 28).

Exclusion criteria

✕. Active ocular infection or ocular inflammatory disease other than dry eye disease
✕. Presence of anterior membrane dystrophy or history of clinically significant recurrent erosion syndrome.
✕. Significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
✕. Prior radial keratotomy at any time or prior laser refractive surgery within the past 12 months of Screening Visit.
✕. 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.
✕. Seated blood pressure \> 140 mmHg (systolic) or \> 90 mmHg (diastolic).
✕. 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).
✕. Pregnant or plans to become pregnant and/or patients who are breastfeeding or plan to breastfeed during the study.

What they're measuring

Tablet group

Timeframe: 28 Days

Injection group

Timeframe: 28 Days

Trial details

NCT IDNCT05895500

SponsorNvision Laser Eye Centers

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-11-09

View on ClinicalTrials.gov More Dry Eye trials