Overview

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