Clinical trial

A Four-Week, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Dry Eye

Name

VP-VSJ-110-2201

Description

The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.

Trial arms

Trial start

2024-02-29

Estimated PCD

2024-07-01

Trial end

2024-07-01

Status

Recruiting

Phase

Early phase I

Treatment

VSJ-110

ophthalmic solution

Arms:

VSJ-110 Solution

Placebo

ophthalmic solution

Arms:

Placebo Solution

Size

Primary endpoint

Schirmer's Tear Test

Measured over a 4-week treatment period

Eligibility criteria

Inclusion Criteria: * Be at least 18 years of age of either gender and any race. * Provide written informed consent and sign the HIPAA form. * Be willing and able to follow all instructions and attend all study visits. Exclusion Criteria: * Use of any of the disallowed medications during the washout and study period.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2024-03-06

1 organization

2 products

1 indication

Product

VSJ-110

Indication

Dry Eye

Organization

Vanda Pharmaceuticals

Product

Placebo