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Title A Single-Center,  Randomized, Controlled, Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation
Therapeutic Area Dry Eye
Principal Investigator Pedram Hamrah, MD
Min Age 18 Years
Gender All
Contact Michael Dixon
More Information


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. 

Study Details

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.