Study of TOP1630 for Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

— THEIA-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833388
• Other study ID #: TOP1630-TV-05
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 13, 2019
• Est. completion date: May 14, 2019

Study information

• Verified date: August 2019
• Source: Topivert Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: May 14, 2019
• Est. primary completion date: May 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• TOP1630 0.1% Ophthalmic Solution TID OU
Bilateral ocular drug administration
• Placebo to TOP1630 0.1% Ophthalmic Solution TID OU
Bilateral ocular drug administration

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Central Maine Eye Care	Lewiston	Maine
United States	Total Eye Care	Memphis	Tennessee
United States	Suite 305, 775 Paramount Drive	Raynham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Topivert Pharma Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular grittiness 6-point (0-5) scale	Ocular grittiness severity assessment	Day 29
Primary	Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region	Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.	Day 29
Secondary	Ocular discomfort 5-point (0-4) scale	Ocular discomfort severity assessment	Day 29
Secondary	Ocular dryness 6-point (0-5) scale	Ocular dryness severity assessment	Day 29
Secondary	Conjunctival lissamine green staining score 5-point (0-4) scale each region	Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal.	Day 29
Secondary	Corneal lissamine green staining score 5-point (0-4) scale each region	Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central.	Day 29
Secondary	Worst ocular symptom 6-point (0-5) scale	Most severe baseline symptom from reported daily symptoms	Day 29