Health TrialsbyHealthPanel

Study of 5% VVN001 Ophthalmic Solution in Dry Eye Disease

ConditionDry Eye
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30-80
SponsorVivaVision Biotech, Inc

About this trial

This is a Phase 3, randomized, double-Masked, vehicle-controlled, multi-center study designed to evaluate the safety and efficacy of 5% VVN001 Ophthalmic Solution versus vehicle in Chinese subjects with dry eye disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provided written informed consent prior to any study-related procedures.

Are between 30 and 80 years of age.

Have a history of dry eye disease in both eyes.

Have been using artificial tears within 30 days of the screening visit

Disqualifiers

Have a known hypersensitivity or contraindication to the IP or components of IP.

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.

Woman of childbearing potential (WOCP) who are pregnant, lactating, or preparing for pregnant.

Trial design

Design model

Parallel

Treatments tested in this trial

  • VVN001 Ophthalmic Solution, 5%

    Drug

    VVN001 Ophthalmic Solution, 5%

  • VVN001 Ophthalmic Solution, Vehicle

    Drug

    VVN001 Ophthalmic Solution, Vehicle

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: VVN001Experimental treatment 1 intervention
Group B: VehiclePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Corneal Fluorescein Staining

Mean Change from baseline (Visit 2) to Day84 (Visit 6) in total corneal fluorescein staining (tCFS) using modified NEI/Industry Workshop (0-4 scale, using 0.5 unit increments).

Time frame
Day 84

Secondary outcomes

1

Eye Dryness

Mean Change from baseline (Visit 2) to Day 84 (Visit 6) in the individual symptom of eye dryness (0\~100 VAS scale).

Time frame
Day 84

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VivaVision Biotech, Inc

Lead sponsor

Source ClinicalTrials.gov
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