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Trial · NCT06293300

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange 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").
PrimaryChange 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.
SecondaryChange in severity of visual photosensitivity symptoms measured by Visual Light Sensitivity Questionnaire-8 (VLSQ-8)Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.Total score ranging from 8 to 40, with a higher score indicating more visual photosensitivity symptom severity.
SecondaryChange in severity of neuropathic ocular pain symptoms measured by Neuropathic Pain Symptom Inventory Questionnaire, modified for the Eye (NPSI-Eye).Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.Total score ranging from 0 to 100, with higher scores reflecting greater neuropathic ocular pain symptom severity.
SecondaryChange in visual function related to activities of daily living measured by Visual Function Questionnaire-25 (VFQ-25)Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.Total score ranging from 0 to 100, with higher scores indicating better quality of life.
SecondaryChange in migraine symptom severity score measured by in Migraine Symptom Severity Score (MSSS)Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.Total score ranging from 0 to 21, with higher scores indicating greater migraine severity.
SecondaryChange in impact of headaches on daily life measured by Headache Impact Test (HIT)-6Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.Total score ranging from 36 to 78, with higher scores indicating greater impact of headaches have on a person's ability to function on the job, at school, at home and in social situations.
SecondaryChange in dry eye symptoms measured by the Dry Eye Questionnaire 5 (DEQ 5)Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.Total score ranging from 0 to 22, with higher scores indicating more dry eye symptoms.
SecondaryChange in ocular surface disease index measured by the Ocular Surface Disease Index (OSDI)Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.Total score ranging from 0 to 100, will be administered to assess dry eye symptoms, with higher scores indicating more dry eye symptoms and impact on daily activities.
SecondaryChange in pain intensity rating of aftersensations (AS) to repeated heat stimulation on the forehead measure by quantitative sensory testing (QST)Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
QST methodology will be used to measure the severity of painful sensations that remain present 15 seconds after presentation of 10 one-second presentations (each separated by one second) of a noxious stimulus to the skin of the forehead. Ratings of the "intensity of pain" on a 0 to 100 numerical rating scale (0 = "no pain"; 100 = "most intense pain imaginable") will be recorded for these aftersensations.
SecondaryChange in temporal summation (TS) of heat pain on the forehead measure by quantitative sensory testing (QST)Baseline, 6-weeks post-intervention, and 12-weeks post-intervention.
QST methodology will be used to measure the increase in pain intensity ratings that occur when repeated noxious stimuli are presented in rapid succession (i.e., temporal summation; TS). Ratings of the "intensity of pain" on a 0 to 100 numerical rating scale (0 = "no pain"; 100 = "most intense pain imaginable"). TS at each study time point will be determined by subtracting the rating of pain intensity at its peak during the rapid train of one-second noxious heat stimuli from the rating of pain intensity after a single one-second heat stimulus of the same temperature.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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