Clinical trial NCT03833388: Study of TOP1630 for Dry Eye Syndrome
Official title: A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of TOP1630 0.1% Ophthalmic Solution Compared to Placebo in Subjects With Moderate to Severe Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye Syndrome
Lead sponsor: Topivert Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2019-02-07
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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-specified sign and symptom endpoints in subjects with moderate to severe DES.

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 or placebo for a duration of 28 days' treatment.

Eligibility 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

Primary outcomes:
measure: Ocular grittiness 6-point (0-5) scale
timeFrame: Day 29
measure: Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region
timeFrame: Day 29
Secondary outcomes:
measure: Ocular discomfort 5-point (0-4) scale
timeFrame: Day 29
measure: Ocular dryness 6-point (0-5) scale
timeFrame: Day 29
measure: Conjunctival lissamine green staining score 5-point (0-4) scale each region
timeFrame: Day 29
measure: Corneal lissamine green staining score 5-point (0-4) scale each region
timeFrame: Day 29
measure: Worst ocular symptom 6-point (0-5) scale
timeFrame: Day 29
Other outcomes:
Locations:
city: Lewiston
country: United States
facility: Central Maine Eye Care
state: Maine
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Raynham
country: United States
facility: Suite 305, 775 Paramount Drive
state: Massachusetts
city: Memphis
country: United States
facility: Total Eye Care
state: Tennessee
Study officials:
References: