Study of TOP1630 for Dry Eye Syndrome

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: TOP1630 0.1% Ophthalmic Solution TID OU; Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU

• Registration Number: NCT03833388
• Lead Sponsor: Topivert Pharma Ltd

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.

Study Timeline

• Study First Submitted: 2019-02-05
• Study First Submitted QC: 2019-02-06
• Study First Posted: 2019-02-07
• Study Start: 2019-02-13
• Primary Completion: 2019-05-14
• Study Completion: 2019-05-14
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TOP1630 Ophthalmic Solution	TOP1630 0.1% Ophthalmic Solution TID OU	-
Placebo to TOP1630 Ophthalmic Solution	Placebo to TOP1630 0.1% Ophthalmic Solution TID OU	-

Primary Outcome Measures

Name	Time	Method
Ocular grittiness 6-point (0-5) scale	Day 29	Ocular grittiness severity assessment
Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region	Day 29	Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.

Secondary Outcome Measures

Name	Time	Method
Ocular discomfort 5-point (0-4) scale	Day 29	Ocular discomfort severity assessment
Ocular dryness 6-point (0-5) scale	Day 29	Ocular dryness severity assessment
Conjunctival lissamine green staining score 5-point (0-4) scale each region	Day 29	Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal.
Corneal lissamine green staining score 5-point (0-4) scale each region	Day 29	Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central.
Worst ocular symptom 6-point (0-5) scale	Day 29	Most severe baseline symptom from reported daily symptoms

Trial Locations

Locations (4)

Suite 305, 775 Paramount Drive; 🇺🇸 Raynham, Massachusetts, United States

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States

Central Maine Eye Care; 🇺🇸 Lewiston, Maine, United States

Total Eye Care; 🇺🇸 Memphis, Tennessee, United States