A Study to Evaluate the Safety and Efficacy of VSJ-110 Co... | NCT06296966

Studies
A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye

NCT06296966

Sponsor

Vanda Pharmaceuticals

Status

Unknown status

Last Update Posted

Mar 6, 2024Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Dry Eye

Interventions

VSJ-110
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 29, 2024Actual

Primary Completion Date

Jul 2024Estimated

Completion Date

Jul 2024Estimated

First Submitted Date

Feb 26, 2024

First Submission Date that Met QC Criteria

Mar 5, 2024

First Posted Date

Mar 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2024

Last Update Posted Date

Mar 6, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VSJ-110 Solution	Experimental		Drug: VSJ-110
Placebo Solution	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VSJ-110	Drug	ophthalmic solution	VSJ-110 Solution
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Schirmer's Tear Test	Schirmer's Tear Test strips are used to measure ocular fluid.	Measured over a 4-week treatment period

Secondary Outcomes

Measure	Description	Time Frame
Ocular Staining	Ocular Staining will be assessed by the investigator on a scale of 0-4, with a higher number indicating a higher grade of staining.	Measured over a 4-week treatment period
Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vanda Pharmaceuticals Inc.	Contact	202-734-3400		clinicaltrials@vandapharma.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanda Investigational Site	Recruiting	Andover	Massachusetts	01810	United States

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided