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The IMPERIAL Study


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
617-636-1051
More Information https://clinicaltrials.gov/ct2/show/NCT03688802

Overview

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.