SI-614 for Eye Diseases

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Andover Eye Associates, Inc., Andover, MA
Eye Diseases+3 More
SI-614 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to evaluate the efficacy and safety of SI-614 ophthalmic solution compared with placebo in patients with dry eye

Eligible Conditions

  • Eye Diseases
  • Dry Eye Syndromes

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Eye Diseases

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 84 days

14 days
Change from baseline to Day 14 in ocular symptom score
29 days
Change from baseline to Day 29 in fluorescein staining score
Up to 84 days
Adverse Events
Best-corrected Visual Acuity
Slit-lamp Biomicroscopy

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Eye Diseases

Trial Design

2 Treatment Groups

SI-614
1 of 2
Vehicle
1 of 2
Experimental Treatment
Non-Treatment Group

230 Total Participants · 2 Treatment Groups

Primary Treatment: SI-614 · Has Placebo Group · Phase 3

SI-614
Drug
Experimental Group · 1 Intervention: SI-614 · Intervention Types: Drug
Vehicle
Drug
PlaceboComparator Group · 1 Intervention: Vehicle · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SI-614
2014
Completed Phase 3
~240

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 84 days
Closest Location: Andover Eye Associates, Inc. · Andover, MA
Photo of massachusetts 1Photo of massachusetts 2Photo of massachusetts 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Eye Diseases
0 CompletedClinical Trials

Who is running the clinical trial?

ORA, Inc.Industry Sponsor
56 Previous Clinical Trials
6,376 Total Patients Enrolled
6 Trials studying Eye Diseases
623 Patients Enrolled for Eye Diseases
Statistics & Data CorporationUNKNOWN
3 Previous Clinical Trials
777 Total Patients Enrolled
Seikagaku CorporationLead Sponsor
13 Previous Clinical Trials
4,248 Total Patients Enrolled
George OuslerStudy DirectorORA, Inc.

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of dry eye in both eyes for at least 6 months prior to Visit 1.
You are a female of childbearing potential

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.