NCT02205840

Brief Summary

The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

July 30, 2014

Last Update Submit

July 10, 2023

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

  • Corneal staining score

    Up to 28 days

  • Symptom score

    Up to 28 days

Study Arms (2)

SI-614

EXPERIMENTAL
Drug: SI-614

Placebo Vehicle

PLACEBO COMPARATOR
Drug: Vehicle

Interventions

SI-614DRUG

1 drop in each eye

SI-614
VehicleDRUG

1 drop in each eye

Placebo Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be at least 18 years of age
  • Have provided written informed consent
  • Have dry eye in both eyes

You may not qualify if:

  • Use of contact lenses
  • Have an uncontrolled systemic disease
  • Have an uncontrolled psychiatric condition, or substance or alcohol abuse
  • Women who is pregnant, nursing or planning a pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Andover, Massachusetts, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2014

First Posted

July 31, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2014

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations

US(1)