Eye Patch for Intermittent Exotropia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Boston Medical Center, Boston, MA
Intermittent Exotropia+1 More
Eye Patch - Device
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at whether covering one eye all the time is better than just monitoring it for improving distance vision in kids after 3 months of treatment. Eye Patch is being used to treat Intermittent Exotropia and has previously been approved by the FDA for a different condition. No patients in this trial will receive a placebo.

Eligible Conditions

  • Intermittent Exotropia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Intermittent Exotropia

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 3 months

3 months
Change in mean distance control scores at 3 months

Trial Safety

Safety Progress

1 of 3

Other trials for Intermittent Exotropia

Side Effects for

Intensified Treatment
5%New ocular deviation or worsening of preexisting deviation by at least 10 pd
This histogram enumerates side effects from a completed 2013 Phase 3 trial (NCT00945100) in the Intensified Treatment ARM group. Side effects include: New ocular deviation or worsening of preexisting deviation by at least 10 pd with 5%.

Trial Design

2 Treatment Groups

Observation Group
1 of 2
Full Time Patching
1 of 2
Active Control
Experimental Treatment

72 Total Participants · 2 Treatment Groups

Primary Treatment: Eye Patch · No Placebo Group · N/A

Full Time Patching
Device
Experimental Group · 1 Intervention: Eye Patch · Intervention Types: Device
Observation GroupNoIntervention Group · 1 Intervention: Observation Group · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Eye Patch
2009
Completed Phase 3
~1020

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
Closest Location: Boston Medical Center · Boston, MA
Photo of Boston 1Photo of Boston 2Photo of Boston 3
2011First Recorded Clinical Trial
3 TrialsResearching Intermittent Exotropia
503 CompletedClinical Trials

Who is running the clinical trial?

Jaeb Center for Health ResearchLead Sponsor
138 Previous Clinical Trials
30,118 Total Patients Enrolled
3 Trials studying Intermittent Exotropia
501 Patients Enrolled for Intermittent Exotropia
National Eye Institute (NEI)NIH
514 Previous Clinical Trials
1,074,003 Total Patients Enrolled
3 Trials studying Intermittent Exotropia
501 Patients Enrolled for Intermittent Exotropia
Pediatric Eye Disease Investigator GroupNETWORK
17 Previous Clinical Trials
4,372 Total Patients Enrolled
3 Trials studying Intermittent Exotropia
501 Patients Enrolled for Intermittent Exotropia
Stephen P Christiansen, MDStudy ChairBoston Children's Hospital
Erin C Jenewein, ODStudy ChairSalus University

Eligibility Criteria

Age < 18 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have 20/50 or better.
20/40 or better (>=68 letters).
You have a distance exodeviation between 15∆ and 50∆ by PACT.
You have a visual acuity of 20/25 or better.

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.