The IMPERIAL Study is a Phase 2, single-center, randomized, controlled, masked study including 45 subjects with Dry Eye Disease (DED). The purpose of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED. The OC-01 Nasal Spray (varenicline tartrate) is an investigational drug intended to treat Dry Eye Disease.
Inclusion Criteria
- Be literate, able to speak English, and able to complete questionnaires independently
- Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to Visit 1.
- Diagnosis of Dry Eye Disease
Exclusion Criteria
- Have chronic or recurrent epistaxis, coagulation disorders or other conditions that may lead to clinically significant risk of increased bleeding
- Have had nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas.
- Have current concomitant use of snuff, chewing tobacco, or cigarettes/cigars during the study or within the previous 30 days
Study Requirements
Approximately 45 subjects at least 18 years of age with a physicians' diagnosis of dry eye disease and meeting all other study eligibility criteria will be randomized to receive an application of OC-01 or placebo at a single visit and have pre- and post-treatment images acquired.
