Study of TOP1630 for Dry Eye Syndrome (THEIA-1)

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: TOP1630 0.1% Ophthalmic Solution TID OU; Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU

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 Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Maine
    • Lewiston, Maine, United States, 04240
      • Central Maine Eye Care
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
    • Raynham, Massachusetts, United States, 02767
      • Suite 305, 775 Paramount Drive
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TOP1630 Ophthalmic Solution	Drug: TOP1630 0.1% Ophthalmic Solution TID OU; Bilateral ocular drug administration
Placebo Comparator: Placebo to TOP1630 Ophthalmic Solution	Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU; Bilateral ocular drug administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular grittiness 6-point (0-5) scale	Ocular grittiness severity assessment	Day 29
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular discomfort 5-point (0-4) scale	Ocular discomfort severity assessment	Day 29
Ocular dryness 6-point (0-5) scale	Ocular dryness severity assessment	Day 29
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
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
Worst ocular symptom 6-point (0-5) scale	Most severe baseline symptom from reported daily symptoms	Day 29

Collaborators and Investigators

• Sponsor: Topivert Pharma Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): May 14, 2019
• Study Completion (Actual): May 14, 2019

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: TOP1630-TV-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No