NCT05462821: IXT7

Full-Time Occlusion Therapy for Intermittent Exotropia in Children

Completed Phase 3 Results posted Last updated 2 December 2025

What this trial tests

Phase 3 trial testing Eye Patch in Intermittent Exotropia in 73 participants. Completed in 1 May 2025.

Timeline

1 November 2022

Primary endpoint
1 May 2025

1 May 2025

Quick facts

Lead sponsor	Jaeb Center for Health Research
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	73
Start date	1 November 2022
Primary completion	1 May 2025
Estimated completion	1 May 2025
Sites	25 locations across United States

Drugs / interventions tested

• Eye Patch

Conditions studied

• Intermittent Exotropia — all drugs for Intermittent Exotropia →

Sponsor

Jaeb Center for Health Research — full company profile →

Who can join

Adults 3 to 8, any sex, with Intermittent Exotropia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With a Change in Mean Distance Control Scores at 3 Months Primary · 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 a

2 to <3

Group	Value	95% CI
Observation Group	1
Full Time Patching	0

1 to <2

Group	Value	95% CI
Observation Group	4
Full Time Patching	4

0 to <1

Group	Value	95% CI
Observation Group	13
Full Time Patching	8

-1 to <0

Group	Value	95% CI
Observation Group	7
Full Time Patching	3

-2 to <-1

Group	Value	95% CI
Observation Group	8
Full Time Patching	9

-3 to <-2

Group	Value	95% CI
Observation Group	1
Full Time Patching	7

-4 to <-3

Group	Value	95% CI
Observation Group	1
Full Time Patching	2

Sponsor's own description

Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Testability and test-retest reliability of SpotChecks Contrast Sensitivity Test in children with unilateral amblyopia.
   Manh VM, Wu R, Gray ME, Cheung NL, et al · · 2026 · PMID 42173804 · DOI 10.1002/ovs2.70058
2. A randomized clinical trial of full-time alternate patching therapy for intermittent exotropia in children.
   Jenewein EC, Christiansen SP, Zhu Y, Kraker RT, et al · · 2026 · PMID 41926779 · DOI 10.1002/ovs2.70015