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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03833388
Recruitment Status : Completed
First Posted : February 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Topivert Pharma Ltd

Study Description
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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.


Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: TOP1630 0.1% Ophthalmic Solution TID OU Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 13, 2019
Actual Primary Completion Date : May 14, 2019
Actual Study Completion Date : May 14, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Ocular grittiness 6-point (0-5) scale [ Time Frame: Day 29 ]
    Ocular grittiness severity assessment

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


Secondary Outcome Measures :
  1. Ocular discomfort 5-point (0-4) scale [ Time Frame: Day 29 ]
    Ocular discomfort severity assessment

  2. Ocular dryness 6-point (0-5) scale [ Time Frame: Day 29 ]
    Ocular dryness severity assessment

  3. Conjunctival lissamine green staining score 5-point (0-4) scale each region [ Time Frame: Day 29 ]
    Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal.

  4. Corneal lissamine green staining score 5-point (0-4) scale each region [ Time Frame: Day 29 ]
    Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central.

  5. Worst ocular symptom 6-point (0-5) scale [ Time Frame: Day 29 ]
    Most severe baseline symptom from reported daily symptoms


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03833388


Locations
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United States, Maine
Central Maine Eye Care
Lewiston, Maine, United States, 04240
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Suite 305, 775 Paramount Drive
Raynham, Massachusetts, United States, 02767
United States, Tennessee
Total Eye Care
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Topivert Pharma Ltd
More Information
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Responsible Party: Topivert Pharma Ltd
ClinicalTrials.gov Identifier: NCT03833388    
Other Study ID Numbers: TOP1630-TV-05
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Syndrome
Disease
Pathologic Processes
Lacrimal Apparatus Diseases
Eye Diseases
 Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Pharmaceutical Solutions
Ophthalmic Solutions