Recruiting
Phase 2

Botulinum Toxin A

Sponsor:

University of Miami

Code:

NCT06293300

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BoNT A

Study Details

Brief summary:

The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.

Conditions

Traumatic Brain Injury

Study ID

NCT06293300

Start date

Sep 30, 2024

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BoNT-A Group

Participants will receive BoNT-A intervention for up to 6 months.

Interventions

BoNT A

Participants with TBI-associated photophobia will come one time in person to the clinic and receive 35 Units of BoNT-A injected in 7 forehead sites (0.1 cc in each location).

Primary outcome measure

  • Change in photophobia measured by Numerical Rating Scale [ Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. ]
  • Change in visual photosensitivity thresholds (VPT) measured Ocular Photosensitivity Analyzer (OPA) [ Time Frame: Baseline, 6-weeks post-intervention, and 12-weeks post-intervention. ]

Central Contacts and Locations

Central contacts

Anat Galor, MD/MSPH

(305) 3266000agalor@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Mariela Aguilar, PhD

3053266069maguilar1@miami.edu

Principal Investigator:

Anat Galor, MD/MSPH

More Information

Sponsor

University of Miami

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-14.