Safety and Efficacy Study of RX-10045 on the Signs and Symptoms of Dry Eye
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Phase II, Multi-Center, Double-Masked, Randomized, Placebo Controlled, Study on the Safety and Efficacy of RX-10045 on the Signs and Symptoms of Dry Eye in Every Day Environmental Conditions and During Provocation Using the Controlled Adverse Environment (CAE) Model
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Be at least 18 years of age;
Have provided written informed consent;
Have a history of dry eye for at least 6 months prior to enrollment;
Have a history of use or desire to use eye drops for dry eye symptoms within the past 6 months;
Demonstrate a response when exposed to the CAE.
Have an on-going ocular infection, or active ocular inflammation
Have worn contact lenses within 72 hours of Visit 1 or have anticipated use of contact lenses during the study;
Have contact lens-induced dry eye;
Have previously had laser in situ keratomileusis (LASIK) surgery;
Be using or have anticipated use of temporary punctual plugs during the study;
Have best corrected visual acuity > +0.7 in both eyes;
Be a woman who is pregnant, nursing or planning a pregnancy;
Have a known allergy and/or sensitivity to the test article or its components;
Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days