Safety and Efficacy of TOP1630 for Dry Eye Syndrome

This is an interventional treatment trial for Dry Eye Syndrome Read More

Inclusion Criteria:

• Be at least 18 years of age;
• Provide written informed consent;
• Have a reported history of dry eye;
• Have a history of use of eye drops for dry eye symptoms;

Additionally for Part 2

Symptoms of dry eye syndrome including:

• Ocular discomfort
• Conjunctival redness
• Tear film break up time
• Schirmer test score

Signs of dry eye syndrome including:

Conjunctival staining score

Exclusion Criteria:

• Have any clinically significant slit lamp findings at entry visit ;
• Be diagnosed with an ongoing ocular infection;
• Have any significant ocular lesion that could interfere with assessment of safety or efficacy or prevent study conduct in the opinion of the PI;
• Have any planned ocular and/or lid surgeries over the study period;
• Have an uncontrolled systemic disease;
• Be a woman who is pregnant, nursing or planning a pregnancy;
• Be a woman of childbearing potential who is not using an acceptable means of birth control;
• Have a known allergy and/or sensitivity to the test article or its components;
• Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;