Intermittent ExotropiaPhase 3IXT7NCT05462821
Full-Time Occlusion Therapy for Intermittent Exotropia in Children
A Phase 3 study testing Eye Patch in people with Intermittent Exotropia, run by Jaeb Center for Health Research at 25 sites in United States.
Trial summary
Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome). Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- Eye Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 25 sitesUnited States
- Study dates
- 1 Nov 2022to 1 May 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children under the care of a pediatric optometrist or pediatric ophthalmologist will be eligible for the study if they meet all the following criteria:
- Age 3 to < 9 years
- IXT meeting all of the following criteria:
- Intermittent or constant XT at distance (mean distance control 2.0 or more) with at least 1 control measure of 3, 4 or 5 (i.e., indicating spontaneous tropia)
- Either IXT, exophoria, or orthophoria at near (cannot have control score of 5 on all 3 near assessments)
- Distance exodeviation between 15∆ and 50∆ by PACT
Show all 35Show fewer
- Near exodeviation between 0∆ and 50∆ by PACT
- Near exodeviation does not exceed distance by more than 10∆ by PACT (convergence insufficiency-type IXT excluded)
- Age-normal visual acuity in both eyes:
- 3 years: 20/50 or better (>=63 letters)
- 4 years: 20/40 or better (>=68 letters)
- 5-6 years: 20/32 or better (>=73 letters)
- 7-<9 years: 20/25 or better (>=78 letters)
- Interocular difference in distance VA of 2 logMAR lines or less (10 letters or less on E-ETDRS for patients ≥7 years old). Testing by ATS HOTV for participants 3 to < 7 years old and by E-ETDRS for participants ≥7 years old.
- Cycloplegic refraction within the last 7 months.
- Refractive error between -6.00 D SE and +2.00 D SE (inclusive) based on a cycloplegic refraction within 7 months
- Participants with refractive error meeting any of the following based on a cycloplegic refraction within 6 months must be wearing spectacles for at least 2 weeks:
- Myopia > -0.50 D spherical equivalent (SE) in either eye
- Anisometropia > 1.00 D SE
- Astigmatism in either eye > 1.00 D
- Any refractive correction worn at enrollment (required or not) must meet the following guidelines based on a cycloplegic refraction within 7 months:
- Anisometropia SE must be within 0.50 D of the full anisometropic difference correction
- Astigmatism must be corrected within 0.50 D
- Axis must be within ±10 degrees if cylinder power is ≤1.00 D and within ±5 degrees if cylinder power is >1.00 D.
- For hyperopia, the spherical component can be reduced at investigator discretion provided the reduction is symmetrical and does not meet the definition of deliberate overminus (see below).
- For myopia, the intent is to fully correct, but the spherical component can be undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Deliberate overminus is not allowed.
- Deliberate overminus is defined for this protocol as any refractive correction prescribed to yield lenses that are overminused by more than -0.50D SE than cycloplegic refraction SE
- Less than the full cycloplegic hyperopic correction (i.e., prescribing reduced plus) is not considered the same as overminusing for this protocol (because most patients without IXT but with hyperopic SE refractions up to +2.00 D SE would not typically be prescribed a refractive correction.)
- For refractive errors with an emmetropic or myopic SE, the intent is to fully correct, but the spherical component can be undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Prescribing a correction that yields more than 0.50 D more minus SE than the cycloplegic refraction SE is considered deliberate overminus and is not allowed.
- Note that the refractive correction guidelines and the requirement to wear refractive correction for at least 2 weeks apply not only to participants who require refractive correction under the above criteria but also to any other participant who is wearing refractive correction.
- Gestational age > 30 weeks
- Birth weight > 1500 grams
- Patient and/or parent understands protocol, is willing to enroll, and is willing to accept that other (i.e., nonrandomized) treatment for IXT will not be offered by the investigator for 3 months
- Parent has phone and is willing to be contacted by Jaeb Center staff
- Relocation outside of area of an active PEDIG site within 3 months not anticipated
Who cannot join
- Individuals meeting any of the following criteria at baseline will be excluded from study participation:
- Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
- Prior nonsurgical treatment for IXT (e.g., patching, vergence therapy, vision therapy/orthoptics, base-in prism, or deliberate overminus (more than 1.00 D) spectacles of >1week duration within the past year
- Previous amblyopia treatment other than refractive correction
- Diplopia more than 2 times per day by parental assessment
- Paretic or restrictive strabismus
Show all 13Show fewer
- Craniofacial malformations affecting the orbits
- Ocular disorders which would reduce VA (except refractive error)
- Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities or ADHD are not excluded.
- Neurological anomaly that could affect ocular motility (e.g., cerebral palsy, Down syndrome)
- Immediate family member (child or sibling) of any investigative site personnel directly affiliated with this study.
- Known allergy to adhesive patches.
- Known allergy to silicone.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Wilmer Eye Institute
Baltimore, Maryland, 21287-9028
Univ. of California- Berkeley
Berkeley, California, 94720
Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan, 49307
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, 35294
Indiana School of Optometry
Bloomington, Indiana, 47405
Boston Medical Center
Boston, Massachusetts, 02118
Boston Children's Hospital Waltham
Boston, Massachusetts, 02453
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Ohio State University College of Optometry
Columbus, Ohio, 43210-1280
Duke University Eye Center
Durham, North Carolina, 27710
Southern California College of Optometry
Fullerton, California, 92831-1699
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, 92697
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Progressive Eye Care
Lisle, Illinois, 60532
Arkansas Childrens
Little Rock, Arkansas, 72202
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, 92354
Southern College of Optometry
Memphis, Tennessee, 38104
State University of New York, College of Optometry
New York, New York, 10036
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502
University of Nebraska Medical Center
Omaha, Nebraska, 68114
Stanford University
Palo Alto, California, 94303
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania, 19141
Eye Care Associates, Inc.
Poland, Ohio, 44514
Casey Eye Institute
Portland, Oregon, 97239
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, 55905
About this study
Official title: Randomized Trial of Full-Time Occlusion Therapy for Intermittent Exotropia in Children
Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).
Read the detailed description
Understanding the effectiveness of intensive patching has important implications for managing children with IXT. If full-time patching is associated with improvement in distance control vs an observation group, then future studies can be conducted to evaluate different durations of full-time patching treatment, whether the effect is maintained off-treatment, and how full-time patching compares to other treatment strategies.
The purpose of this study is to determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).
- Conditions
- Intermittent Exotropia
- Being tested
- Eye Patch
- Keywords
- IXT, intermittent exotropia, occlusion therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye PatchDevice
adhesive patch to cover eye
| Study group | Role | What they receive |
|---|---|---|
| Observation Group | No intervention | Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months. |
| Full Time Patching | Experimental | Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction. Receives: Device: Eye Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Change in Mean Distance Control Scores at 3 Months
To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment.
The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Measured: 3 months
Primary Outcome Measure Stratified by Sex
NIH-required analysis. Primary outcome measure (stratified by sex):
To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment.
The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Measured: 3 Months
Primary Outcome Measure Stratified by Race
NIH-required analysis. Primary outcome measure (stratified by race):
To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment.
The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Measured: 3 months
Primary Outcome Measure Stratified by Ethnicity
NIH-required analysis. Primary outcome measure (stratified by ethnicity):
To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment.
The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Measured: 3 months
Primary Outcome: Mean Change in Distance Control Score at 3 Months
To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment.
The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Nov 2022
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
- Responsible party
- Sponsor
- Investigators
- Stephen P Christiansen, MD, Study chair, Boston Children's HospitalErin C Jenewein, OD, Study chair, Salus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462821
- Sponsor's protocol ID
- IXT7
- Other IDs
- 2U10EY011751
- Acronym
- IXT7
- Status last verified
- Jun 2026
- First submitted
- 14 Jul 2022
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
Publications
Hatt SR, Leske DA, Holmes JM, Henderson RJ, Chandler DL, Morrison DG, Summers AI, Cotter SA. Testing depth of suppression in childhood intermittent exotropia. J AAPOS. 2022 Feb;26(1):36-38.e1. doi: 10.1016/j.jaapos.2021.08.303. Epub 2021 Nov 16.
PubMed 34793970Manh VM, Wu R, Gray ME, Cheung NL, Cotter SA, Erickson JW, Fisher JH, Galvin JA, Gunton KB, Jastrzembski BG, Raghuram A, Burgher AP, Whitfield KO, Beaulieu WT, Kraker RT, Weise KK, Pineles SL, Holmes JM; Pediatric Eye Disease Investigator Group. Testability and test-retest reliability of SpotChecks Contrast Sensitivity Test in children with unilateral amblyopia. Optom Vis Sci. 2026 May;103(5):e70058. doi: 10.1002/ovs2.70058.
PubMed 42173804Jenewein EC, Christiansen SP, Zhu Y, Kraker RT, Grigorian AP, Suh DW, Summers AI, Han S, Rahmani B, Connolly KS, Davis PL, Fisher JH, Javed YF, Kraus CL, Kurup SP, Martinson SR, Ollinger MC, Tauscher RG, Vricella M, Beaulieu WT, Pineles SL, Cotter SA, Holmes JM, Weise KK; Pediatric Eye Disease Investigator Group. A randomized clinical trial of full-time alternate patching therapy for intermittent exotropia in children. Optom Vis Sci. 2026 Feb;103(2):e70015. doi: 10.1002/ovs2.70015.
PubMed 41926779
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Full-Time Occlusion Therapy for Intermittent Exotropia in Children
- ClinicalTrials.gov ID
- NCT05462821
- Acronym / sponsor ID
- IXT7 / IXT7
- Conditions
- Intermittent Exotropia
- Keywords
- IXT, intermittent exotropia, occlusion therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).
Detailed description
Understanding the effectiveness of intensive patching has important implications for managing children with IXT. If full-time patching is associated with improvement in distance control vs an observation group, then future studies can be conducted to evaluate different durations of full-time patching treatment, whether the effect is maintained off-treatment, and how full-time patching compares to other treatment strategies.
The purpose of this study is to determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation Group | No intervention | –Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months. |
| Full Time Patching | Experimental | Device: Eye PatchParticipants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (35 listed)
- Children under the care of a pediatric optometrist or pediatric ophthalmologist will be eligible for the study if they meet all the following criteria:
- Age 3 to < 9 years
- IXT meeting all of the following criteria:
- Age-normal visual acuity in both eyes:
- Interocular difference in distance VA of 2 logMAR lines or less (10 letters or less on E-ETDRS for patients ≥7 years old). Testing by ATS HOTV for participants 3 to < 7 years old and by E-ETDRS for participants ≥7 years old.
Key exclusion criteria (13 listed)
- Individuals meeting any of the following criteria at baseline will be excluded from study participation:
- Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
- Prior nonsurgical treatment for IXT (e.g., patching, vergence therapy, vision therapy/orthoptics, base-in prism, or deliberate overminus (more than 1.00 D) spectacles of >1week duration within the past year
- Previous amblyopia treatment other than refractive correction
- Diplopia more than 2 times per day by parental assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Patchadhesive patch to cover eye | Device | Full Time Patching |
Primary outcome
Number of Participants With a Change in Mean Distance Control Scores at 3 Months
Time frame: 3 months
To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Primary Outcome Measure Stratified by Sex
Time frame: 3 Months
NIH-required analysis. Primary outcome measure (stratified by sex): To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Primary Outcome Measure Stratified by Race
Time frame: 3 months
NIH-required analysis. Primary outcome measure (stratified by race): To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Primary Outcome Measure Stratified by Ethnicity
Time frame: 3 months
NIH-required analysis. Primary outcome measure (stratified by ethnicity): To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Primary Outcome: Mean Change in Distance Control Score at 3 Months
Time frame: 3 months
To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment. The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34793970Hatt SR, Leske DA, Holmes JM, Henderson RJ, Chandler DL, Morrison DG, Summers AI, Cotter SA. Testing depth of suppression in childhood intermittent exotropia. J AAPOS. 2022 Feb;26(1):36-38.e1. doi: 10.1016/j.jaapos.2021.08.303. Epub 2021 Nov 16.
- Derived from this study: PubMed 42173804Manh VM, Wu R, Gray ME, Cheung NL, Cotter SA, Erickson JW, Fisher JH, Galvin JA, Gunton KB, Jastrzembski BG, Raghuram A, Burgher AP, Whitfield KO, Beaulieu WT, Kraker RT, Weise KK, Pineles SL, Holmes JM; Pediatric Eye Disease Investigator Group. Testability and test-retest reliability of SpotChecks Contrast Sensitivity Test in children with unilateral amblyopia. Optom Vis Sci. 2026 May;103(5):e70058. doi: 10.1002/ovs2.70058.
- Derived from this study: PubMed 41926779Jenewein EC, Christiansen SP, Zhu Y, Kraker RT, Grigorian AP, Suh DW, Summers AI, Han S, Rahmani B, Connolly KS, Davis PL, Fisher JH, Javed YF, Kraus CL, Kurup SP, Martinson SR, Ollinger MC, Tauscher RG, Vricella M, Beaulieu WT, Pineles SL, Cotter SA, Holmes JM, Weise KK; Pediatric Eye Disease Investigator Group. A randomized clinical trial of full-time alternate patching therapy for intermittent exotropia in children. Optom Vis Sci. 2026 Feb;103(2):e70015. doi: 10.1002/ovs2.70015.
- Individual participant dataSharing planned: Yes. In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen P Christiansen, MD study chair
Boston Children's Hospital
Erin C Jenewein, OD study chair
Salus University
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Eye Patch in people with Intermittent Exotropia, run by Jaeb Center for Health Research at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Change in Mean Distance Control Scores at 3 Months (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05462821, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.