Dry Eye Disease
Conditions
Interventions
The study participants will receive one of the two treatments as per the randomization schedule for 4 weeks.
1. OC-01 (varenicline) nasal spray 0.6 mg/mL to deliver 50 uL/spray. One spray intranasall
Sponsors
Terakawa Takehiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 2. - Have an J-OSDI score of >=13 with =40 at Visit 2. - Have the following in the study eye* at Visit 1 and Visit 2: - A TBUT <=5 seconds - A physician's diagnosis of DED * The study eye will be defined as the eye that met all inclusion criteria at Visit 1 and/or Visit 2; if both eyes qualified, then the eye with the lesser TBUT at the Baseline visit 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 an active allergic rhinitis (including hay fever) receiving drug treatment such as antihistamines and steroids OR participants requiring treatment with intranasal steroids and/or intranasal antihistamines for any other reasons. - Have had any intraocular surgery (such as cataract surgery) or extraocular surgery 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 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 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; etc. Blepharitis not requiring prescription treatment and mild meibomian gland disease (MGD) that are typically associated with DED are allowed. MGD that required any topical or systemic antibiotics or topical steroids or other prescription medical treatment within the last 30 days prior to Visit 2 or will require such treatment during the trial will be excluded. - Have a history of seizures or other factors that lower the subject's seizure threshold. - 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, etc.) - 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 subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in Tear Film Break up Time (TBUT) at Week 4 (Day 29) | — |
Contacts
Public ContactIQVIA Services Japan G.K jRCT Inquiry Receipt Cont
IQVIA Services Japan G.K
Outcome results
None listed