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
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
Treatments tested in this trial
- VVN001 Ophthalmic Solution, 5%
- VVN001 Ophthalmic Solution, Vehicle
Treatment groups
700 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov