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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TOP1630 0.1% Ophthalmic Solution TID OU
Placebo to TOP1630 0.1% Ophthalmic Solution TID OU
Sponsored by
Topivert Pharma Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Central Maine Eye Care
  • Andover Eye Associates
  • Suite 305, 775 Paramount Drive
  • Total Eye Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TOP1630 Ophthalmic Solution

Placebo to TOP1630 Ophthalmic Solution

Arm Description

Outcomes

Primary Outcome Measures

Ocular grittiness 6-point (0-5) scale
Ocular grittiness severity assessment
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.

Secondary Outcome Measures

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

Full Information

First Posted
February 5, 2019
Last Updated
August 6, 2019
Sponsor
Topivert Pharma Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03833388
Brief Title
Study of TOP1630 for Dry Eye Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
May 14, 2019 (Actual)
Study Completion Date
May 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Topivert Pharma Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TOP1630 Ophthalmic Solution
Arm Type
Experimental
Arm Title
Placebo to TOP1630 Ophthalmic Solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TOP1630 0.1% Ophthalmic Solution TID OU
Intervention Description
Bilateral ocular drug administration
Intervention Type
Drug
Intervention Name(s)
Placebo to TOP1630 0.1% Ophthalmic Solution TID OU
Intervention Description
Bilateral ocular drug administration
Primary Outcome Measure Information:
Title
Ocular grittiness 6-point (0-5) scale
Description
Ocular grittiness severity assessment
Time Frame
Day 29
Title
Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region
Description
Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
Ocular discomfort 5-point (0-4) scale
Description
Ocular discomfort severity assessment
Time Frame
Day 29
Title
Ocular dryness 6-point (0-5) scale
Description
Ocular dryness severity assessment
Time Frame
Day 29
Title
Conjunctival lissamine green staining score 5-point (0-4) scale each region
Description
Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal.
Time Frame
Day 29
Title
Corneal lissamine green staining score 5-point (0-4) scale each region
Description
Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central.
Time Frame
Day 29
Title
Worst ocular symptom 6-point (0-5) scale
Description
Most severe baseline symptom from reported daily symptoms
Time Frame
Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Central Maine Eye Care
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Suite 305, 775 Paramount Drive
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
Total Eye Care
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Study of TOP1630 for Dry Eye Syndrome

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