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Safety and Efficacy of TOP1630 for Dry Eye Syndrome

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: NCT03088605
Recruitment Status : Completed
First Posted : March 23, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Topivert Pharma Ltd

Brief Summary:

In subjects with Dry Eye Syndrome:

The primary objective of this study is to compare the safety and tolerability of TOP1630 Ophthalmic Solution to placebo.

The secondary objectives are to compare the efficacy of TOP1630 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye syndrome.


Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: TOP1630 Ophthalmic Solution Drug: Placebo to TOP1630 Ophthalmic Solution Phase 2

Detailed Description:

This study is designed to assess the safety, tolerability and efficacy of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome.

Eligible subjects will be randomized double masked to either TOP1630 or placebo.

Part 1 (time frame 12 days) comprises assessment of safety, tolerability and ocular comfort.

Part 2 (time frame 35 days) comprises assessment of safety, tolerability and efficacy

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of TOP1630 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Syndrome
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : June 15, 2017
Actual Study Completion Date : June 15, 2017

Arm Intervention/treatment
Experimental: Active
TOP1630 Ophthalmic Solution
Drug: TOP1630 Ophthalmic Solution
Bilateral ocular drug administration

Placebo Comparator: Placebo
Placebo (Vehicle) Ophthalmic Solution
Drug: Placebo to TOP1630 Ophthalmic Solution
Bilateral ocular drug administration




Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: Part 1: 12 days time frame; Part 2: 35 days time frame ]
    Visual Acuity will be measured using the EDTRS chart to assess changes from baseline

  2. Slit-lamp Biomicroscopy [ Time Frame: Part 1: 12 days time frame; Part 2: 35 days time frame ]
    Slit lamp biomicroscopy exams will be performed to assess any changes from baseline

  3. Vital Signs [ Time Frame: Part 1: 12 days time frame; Part 2: 35 days time frame ]
    Blood Pressure, Pulse and SPo2 will be performed to assess changes from baseline

  4. Drop Comfort Assessment [ Time Frame: Part 1: 12 days time frame ]
    The comfort of the eye drop will be performed to assess changes from baseline

  5. Intraocular pressure [ Time Frame: Part 1: 12 days time frame; Part 2: 35 days time frame ]
    a non-contact tonometer will be used to perform IOP to assess changes from baseline

  6. Corneal sensitivity [ Time Frame: Part 1: 12 days time frame; Part 2: 35 days time frame ]
    The aesthesiometer will be used to perform corneal sensitivity to assess changes from baseline

  7. Undilated Fundoscopy [ Time Frame: Part 2: 35 days time frame ]
    Non-Contact undilated fundoscopy exam will be performed to assess changes from baseline

  8. Adverse events [ Time Frame: Part 1: 12 days time frame; Part 2: 35 days time frame ]
    Adverse event questioning


Secondary Outcome Measures :
  1. Ocular discomfort [ Time Frame: Part 2: 35 days time frame ]
    Ocular discomfort severity assessments

  2. Dry eye symptoms [ Time Frame: Part 2: 35 days time frame ]
    Dry eye syndrome symptom assessments

  3. Dry eye signs [ Time Frame: Part 2: 35 days time frame ]
    Dry eye syndrome conjunctival staining assessments

  4. Tear film break up time [ Time Frame: Part 2: 35 days time frame ]
    Tear film break up time measured after instillation of sodium fluorescein solution

  5. Schirmer's test [ Time Frame: Part 2: 35 days time frame ]
    Measurement of Schirmer test strips

  6. Impression cytology [ Time Frame: Part 2: 35 days time frame ]
    Impression cytology

  7. Daily symptom assessment [ Time Frame: Part 2: 35 days time frame ]
    Daily symptom assessment using diary cards



Information from the National Library of Medicine

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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;

Additionally for Part 2

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;

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): NCT03088605


Locations
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Topivert Pharma Ltd
Investigators
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Principal Investigator: G Torkildsen, MD Andover Eye Associates
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Responsible Party: Topivert Pharma Ltd
ClinicalTrials.gov Identifier: NCT03088605    
Other Study ID Numbers: TOP1630-TV-04
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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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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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions