Dry Eye Disease Dry Eye Disease
Conditions
Interventions
The investigational drug is administered into both nostrils.
Sponsors
Kondo Yuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Japanese Healthy Volunteers
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Pharmacokinetic data Part B: Mean change from baseline in TMH Mean change from baseline in NIBUT | — |
Contacts
Public ContactYuko Kondo
Viatris Pharmaceuticals Japan G.K.
Outcome results
None listed