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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

Tracking Information
First Submitted Date  ICMJE February 5, 2019
First Posted Date  ICMJE February 7, 2019
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE February 13, 2019
Actual Primary Completion Date May 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
  • Ocular grittiness 6-point (0-5) scale [ Time Frame: Day 29 ]
    Ocular grittiness severity assessment
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
  • Ocular discomfort 5-point (0-4) scale [ Time Frame: Day 29 ]
    Ocular discomfort severity assessment
  • Ocular dryness 6-point (0-5) scale [ Time Frame: Day 29 ]
    Ocular dryness severity assessment
  • 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.
  • 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.
  • Worst ocular symptom 6-point (0-5) scale [ Time Frame: Day 29 ]
    Most severe baseline symptom from reported daily symptoms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TOP1630 for Dry Eye Syndrome
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndrome
Intervention  ICMJE
  • Drug: TOP1630 0.1% Ophthalmic Solution TID OU
    Bilateral ocular drug administration
  • Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU
    Bilateral ocular drug administration
Study Arms  ICMJE
  • Experimental: TOP1630 Ophthalmic Solution
    Intervention: Drug: TOP1630 0.1% Ophthalmic Solution TID OU
  • Placebo Comparator: Placebo to TOP1630 Ophthalmic Solution
    Intervention: Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2019)
202
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
200
Actual Study Completion Date  ICMJE May 14, 2019
Actual Primary Completion Date May 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03833388
Other Study ID Numbers  ICMJE TOP1630-TV-05
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Topivert Pharma Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Topivert Pharma Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Topivert Pharma Ltd
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP