Status:
COMPLETED
Study of TOP1630 for Dry Eye Syndrome
Lead Sponsor:
Topivert Pharma Ltd
Conditions:
Dry Eye Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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-speci...
Detailed Description
This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome (DES). Eligible subjects will be randomized double masked to either TOP1630 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2019
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT03833388
Start Date
February 13 2019
End Date
May 14 2019
Last Update
August 7 2019
Active Locations (4)
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1
Central Maine Eye Care
Lewiston, Maine, United States, 04240
2
Andover Eye Associates
Andover, Massachusetts, United States, 01810
3
Suite 305, 775 Paramount Drive
Raynham, Massachusetts, United States, 02767
4
Total Eye Care
Memphis, Tennessee, United States, 38119