Study of TOP1630 for Dry Eye Syndrome

• Status: Completed
• Trial end date: 2019-05-14
• Target enrollment: 0
• Participant gender: All

Summary

In subjects with Dry Eye Syndrome (DES):

The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Topivert Pharma Ltd
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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;

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