Dry Eye Disease
Conditions
Interventions
The study participants will receive OC-01 (varenicline) nasal spray 0.6 mg/mL delivered as 50 uL/spray. One spray intranasally in each nostril, twice daily (BID, approximately 12 hours apart) for 52 w
Sponsors
Terakawa Takehiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Japanese male or female participants with prior diagnosis of DED and at least 18 years of age at Visit 1. -Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 2. -Have the following in the study eye* at Visit 1 and Visit 2: -A Tear Film Break-up Time (TBUT) <=5 seconds -A physician's diagnosis of dry eye disease *The study eye will be defined as the eye that meets all inclusion criteria at Visit 1 and Visit 2; if both eyes qualified, then the eye with the lesser TBUT at the Baseline visit (Visit 2) or, if there was no difference in TBUT, the right eye to be used as the study eye.
Exclusion criteria
Exclusion criteria: -Have used Diquafosol, Rebamipide and/or Hyaluronate sodium ophthalmic drops in the past 14 days prior to the Visit 2 (use of artificial tears is allowed, but it should not contain hyaluronate sodium). -Have a vascularized polyp, severely deviated septum, chronic recurrent nosebleeds, or severe nasal airway obstruction as confirmed by intranasal examination performed prior to Visit 2. -Have had any intraocular surgery (such as cataract surgery) or extraocular surgery (such as blepharoplasty) in either eye within three months or keratorefractive surgery (e.g., laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within 12 months of Visit 2. - Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, - Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as but not limited to significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; trichiasis; entropion; etc. Blepharitis not requiring prescription treatment is allowed. - Meibomian gland disease (MGD) that required any topical or systemic antibacterials or topical steroids or other treatment (intense pulsed light therapy [IPL]) within the last 30 days prior to Visit 2 or will require such treatment during the trial will be excluded. Note: Mild MGD that is typically associated with DED is allowed. -Have a known hypersensitivity to any of the procedural agents or study drug components. -Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the participant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-emergent adverse events (TEAE) and Serious Adverse Events (SAE) | — |
Contacts
Public ContactjRCT Inquiry Receipt Center IQVIA Services Japan G.K
IQVIA Services Japan G.K
Outcome results
None listed