NCT01558999

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
150

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

March 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

March 18, 2012

Last Update Submit

May 10, 2023

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

  • Mean change from baseline in TFBUT

    Day 27

  • Mean change from baseline in symptom score

    Day 21 - 27

Study Arms (3)

High concentration SI-614

EXPERIMENTAL
Drug: High concentration SI-614

Low concentration SI-614

EXPERIMENTAL
Drug: Low concentration SI-614

Vehicle

PLACEBO COMPARATOR
Drug: Vehicle

Interventions

High concentration SI-614DRUG

1 drop in each eye 4 times a day

High concentration SI-614
Low concentration SI-614DRUG

1 drop in each eye 4 times a day

Low concentration SI-614
VehicleDRUG

1 drop in each eye 4 times a day

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 a history of 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)

SKK Investigational Site

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

March 18, 2012

First Posted

March 20, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2012

Last Updated

May 11, 2023

Record last verified: 2023-05

Locations

US(1)