Clincosm LogoSign in Get a demo

Study of VVN001 Ophthalmic Solution in Dry Eye Disease

Sponsor
VivaVision Biotech, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT04556838
Collaborator
(none)
169
Enrollment
1
Location
3
Arms
11.9
Actual Duration (Months)
14.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: VVN001 Ophthalmic Solution 1%
  • Drug: VVN001 Ophthalmic Solution 5%
  • Drug: Vehicle
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
169 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double-masked parallelDouble-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
Actual Study Start Date :
Dec 3, 2020
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Inferior Corneal Fluorescein Staining [Day 84]

    Mean change from baseline in Inferior corneal fluorescein staining

Secondary Outcome Measures

  1. Total Corneal Fluorescein Staining [Each visit through Day 84]

    Mean change from baseline in total corneal fluorescein staining

  2. Regional Corneal Fluorescein Staining [Each visit through Day 84]

    Mean change from baseline in each regional corneal fluorescein staining

  3. Eye Dryness [Each visit through Day 84]

    Eye Dryness VAS

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Lexitas Durham North Carolina United States 27703

Sponsors and Collaborators

  • VivaVision Biotech, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VivaVision Biotech, Inc
ClinicalTrials.gov Identifier:
NCT04556838
Other Study ID Numbers:
  • VVN001-CS-201
First Posted:
Sep 21, 2020
Last Update Posted:
Feb 2, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions

Study Results

No Results Posted as of Feb 2, 2022