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Study of VVN001 Ophthalmic Solution in Dry Eye Disease

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ClinicalTrials.gov Identifier: NCT04556838
Recruitment Status : Not yet recruiting
First Posted : September 21, 2020
Last Update Posted : September 22, 2020
Sponsor:
Information provided by (Responsible Party):
VivaVision Biotech, Inc

Brief Summary:
This is a Phase 2a, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and tolerability and to explore the efficacy activity of VVN001 ophthalmic solution versus vehicle in subjects with dry eye disease.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: VVN001 Ophthalmic Solution 1% Drug: VVN001 Ophthalmic Solution 5% Drug: Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-masked parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-masked
Primary Purpose: Treatment
Official Title: A Phase 2a, Double-Masked, Randomized, Vehicle-controlled Trial Evaluating the Safety and Efficacy Activity of 1% and 5% VVN001 Compared to Vehicle in Subjects With Dry Eye Disease
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: VVN001, 1%
VVN001, 1% ophthalmic solution
Drug: VVN001 Ophthalmic Solution 1%
VVN001 Ophthalmic Solution 1%

Experimental: VVN001, 5%
VVN001, 5% ophthalmic solution
Drug: VVN001 Ophthalmic Solution 5%
VVN001 Ophthalmic Solution 5%

Placebo Comparator: Vehicle
VVN001 Ophthalmic Solution Placebo
Drug: Vehicle
VVN001 Ophthalmic Solution Vehicle




Primary Outcome Measures :
  1. Inferior Corneal Fluorescein Staining [ Time Frame: Day 84 ]
    Mean change from baseline in Inferior corneal fluorescein staining


Secondary Outcome Measures :
  1. Total Corneal Fluorescein Staining [ Time Frame: Each visit through Day 84 ]
    Mean change from baseline in total corneal fluorescein staining

  2. Regional Corneal Fluorescein Staining [ Time Frame: Each visit through Day 84 ]
    Mean change from baseline in each regional corneal fluorescein staining

  3. Eye Dryness [ Time Frame: Each visit through Day 84 ]
    Eye Dryness VAS



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:

  • Provide written informed consent prior to any study-related procedures .
  • Are 18 years of age or older.
  • Are willing and able to follow instructions and willing to be present for the required study visits for the duration of the study.
  • Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in the qualifying eye(s) of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) at the screening visit and randomization visit.
  • Have a history of dry eye disease in both eyes
  • Are currently using artificial tears and have been using within 30 days of the screening visit.
  • Have an Eye dryness score ≥40 at Visit 1 and ≥35 at Visit 2, one score for both eyes (0-100 point VAS)
  • Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2:
  • Inferior CFS (iCFS) score of ≥2 (NEI; 0-4 scale; using 0.5 unit increments)
  • Have a Schirmer score (without anesthesia) of ≥1 and ≤7 mm/5 min.

Exclusion Criteria:

  • Have a known hypersensitivity or contraindication to the IP or components of IP.
  • Have a Schirmer score (without anesthesia) of <1 or >7 mm/5 min in the study eye.
  • Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of 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): NCT04556838


Contacts
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Contact: Jennifer Daniels (919) 595-0257 Jennifer.Daniels@lexitas.com

Locations
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United States, North Carolina
Lexitas
Durham, North Carolina, United States, 27703
Contact: Jennifer Daniels    919-595-0257    Jennifer.Daniels@lexitas.com   
Sponsors and Collaborators
VivaVision Biotech, Inc
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Responsible Party: VivaVision Biotech, Inc
ClinicalTrials.gov Identifier: NCT04556838    
Other Study ID Numbers: VVN001-CS-201
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions