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Understanding and Treating TBI-Associated Photophobia with BoNT-A

This study is looking into how to understand and treat photophobia (light sensitivity) that happens after a traumatic brain injury (TBI). Researchers want to see if a drug called BoNT-A (Botulinum Toxin Type A) can help reduce this light sensitivity and improve your vision. You might be able to join if you are 18 or older, have experienced chronic photophobia for at least six months, and had a TBI more than a year ago. The study will measure changes in your light sensitivity and how your eyes react to light to see if the treatment is successful. The study plans to enroll 50 participants.

Study design
This is an interventional study planning to enroll 50 participants. It is not specified if it is randomized or blinded.
What's involved
You will come to the clinic one time to receive 35 units of BoNT-A injected into seven spots on your forehead. Your photophobia and visual photosensitivity will be measured at baseline, 6 weeks, and 12 weeks after the injection.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed for 12 weeks after the intervention.

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NCT06293300

Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Miami
~50 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:BoNT A

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in photophobia measured by Numerical Rating Scale
Measured over Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
+1 more outcome measured

Conditions

Traumatic Brain Injury

Explore related trials

Traumatic Encephalopathy

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Anat Galor, MD/MSPH · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Anat Galor, MD/MSPH
[email protected]
(305) 3266000
Email the study team

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Eligibility criteria

Inclusion

Recruit and enroll male and female subjects, civilians and veterans (1:1 mix anticipated, i.e., n = 25 from each group) of all races and ethnicities.
≥18 years of age who are able to consent.
Report chronic photophobia (Numerical Rating Scale ≥4 on a 0-10 scale, photophobia present ≥6 months) with a remote history of TBI (\>1 year).
Inclusion into the study with regard to TBI status will be based on the Department of Defense Standard Surveillance Case Definition for TBI Adapted for Armed Forces Health Surveillance Division (AFHSB) Use. This can include one hospitalization or outpatient medical encounter with documented International Classification of Diseases (ICD9/ICD10) codes as identified within the Surveillance Case Definition.
Subjects must also have been on a stable medication regimen for the past 3 months and must be naïve to BoNT-A treatment for orofacial conditions.
English as primary language (by self-report).

Exclusion

Individuals with ocular diseases that may confound photophobia, such as glaucoma, corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, retinal degeneration, etc.
Patients who are participating in another study with an investigational drug within one month prior to screening.
Pregnant individuals. Pregnant subjects will not be scanned in the functional Magnetic Resonance Imaging (fMRI). Although there are no known risks associated with MRI during pregnancy, according to facility policy, University of Miami will not scan someone that is pregnant. Therefore, all women of childbearing potential (menstruating or \>12 years old) must complete a for stating that are not pregnant within 24 hours of each MRI scan.
Individuals with contraindications to fMRI scanning (e.g. metal implants, pacemaker) will not be offered inclusion.

What this trial measures

  • Change in photophobia measured by Numerical Rating ScaleBaseline, 6-weeks post-intervention, and 12-weeks post-intervention.

    The change in numerical rating of average photophobia during the past week, ranging from 0 (for "no ocular pain") to 10 ("the most intense ocular pain imaginable").

  • Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA)Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.

    The change in the OPA visual photosensitivity thresholds, ranging from 0 to 4.51 log lux, with a lower VPT indicating less tolerance to light or increased light sensitivity.