An Eight-Week Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye

Vanda Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Dry Eye

Treatments: Drug: Placebo; Drug: VSJ-110

Study type: Interventional

Funder types: Industry

Identifiers

NCT07179055

VP-VSJ-110-2202

Details and patient eligibility

About

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

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

VSJ-110 Solution

Experimental group

Treatment:

Drug: VSJ-110

Placebo Solution

Placebo Comparator group

Treatment:

Drug: Placebo