An interventional study of ALTIUS® daily disposable performance-tinted contact lenses in Post Concussion Symptoms, sponsored by Southern College of Optometry. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Southern College of Optometry · Not applicable, Interventional, and Treatment
Among 77 studies in Post-Concussion Syndrome with a site in United States — 15 open to participants now, 20 under way, 1 of them phase 3. Post-Concussion Syndrome · United States.
Among the 77 studies in Post-Concussion Syndrome with a site in United States, this one is the 53rd largest by enrollment of the 61 interventional ones that give a count, is one of 7 that started in 2026, is one of 35 with no phase, and was the 74th registered.
141 studies on the registry are indexed under Post-Concussion Syndrome; 34 are open to participants now.
Browse Post-Concussion Syndrome studies →15 of the 77 studies in Post-Concussion Syndrome with a site in United States are open now. Recruiting first, the newest first:
Summit Hyperbarics and Wellness · Sites in United States
Summit Hyperbarics and Wellness · Sites in United States
Summit Hyperbarics and Wellness · Sites in United States
Neuroscience Group · Sites in United States
University of Wisconsin, Madison · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 24 Post-Concussion Syndrome studies recruiting now, 3 (13%) set no upper age limit and 20 (83%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
77 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 15 · Phase 3 2 · Phase 4 2
First in 2004; this study’s year is marked. 7 started in 2026.
This study's enrollment of 10 is below the median of 52 across 114 interventional studies indexed under Post-Concussion Syndrome.
Median enrollment 40 across the 61 interventional studies, 90 across the 16 observational. Of the 51 that completed or were terminated, 13 (25%) have results posted.
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3 of 77 have an industry lead sponsor. The 10 most frequent:
Southern College of Optometry is the lead sponsor of 18 studies on the registry; 10 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Southern College of Optometry has 1 study filed under Post-Concussion Syndrome — fewer than ten, so there is no comparison to draw.
8 of the studies in Post-Concussion Syndrome with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04978571Children's Hospital of Orange CountyPercutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS) | 2026-12 |
| NCT07303933Penn State UniversityFemale Concussion Head Cooling | 2027-01-01 |
| NCT07044596University of Wisconsin, MadisonNon-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline | 2027-06 |
| NCT07732374Summit Hyperbarics and WellnessLong-Term Outcomes Following HBOT | 2027-06-18 |
| NCT04760899University of IowaCerebellar TDCS for SRPCS Treatment | 2027-07 |
Among the 77 studies in Post-Concussion Syndrome with a site in United States, from their registry updates:
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This pilot study evaluates whether ALTIUS® daily disposable performance-tinted contact lenses provide symptom relief comparable to tinted spectacle lenses in adults with post-concussion visual syndrome.
Participants who currently use tinted spectacles for post-concussion symptoms will be fitted with ALTIUS tinted contact lenses and complete a one-week trial. Outcomes will include changes in Brain Injury Vision Symptom Survey (BIVSS) scores, patient comfort, symptom relief, and preference for future lens use.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants currently benefiting from tinted spectacles will undergo baseline symptom assessment, be fitted with ALTIUS tinted contact lenses, complete a one-week lens trial, and then undergo post-trial symptom and preference evaluations.
Device: ALTIUS® daily disposable performance-tinted contact lenses
ALTIUS® daily disposable performance-tinted contact lenses of either Amber tint or Grey-Green tint, selected based on subject preference.
Change in Brain Injury Vision Symptom Survey (BIVSS) Score
The primary outcome is the change in visual symptom burden as measured by the Brain Injury Vision Symptom Survey (BIVSS), a validated questionnaire used to assess the frequency and severity of vision-related symptoms associated with acquired brain injury and concussion. Participants will complete the BIVSS while using their habitual tinted spectacle lenses at baseline and again after one week of wear with ALTIUS® performance-tinted contact lenses. Total BIVSS scores range from 0 to 116, with higher scores indicating greater symptom severity. The change in total BIVSS score from baseline to the end of the contact lens trial will be used to evaluate whether ALTIUS tinted contact lenses provide symptom relief comparable to participants' habitual tinted spectacles.
Time frame: Baseline, after minimum of 1 week of tinted spectacle wear, and 1 week following initiation of ALTIUS tinted contact lens wear.
Participant Preference for Future Lens Use
Participant-reported preference regarding the future use of ALTIUS® performance-tinted contact lenses following completion of the one-week trial period. Subjects will indicate whether they would prefer to use the tinted contact lenses regularly, occasionally for specific activities or environments, or not at all. Responses will be collected using a study-specific post-trial questionnaire and summarized descriptively.
Time frame: 1 week
Contact Lens Comfort Rating
Subjective comfort associated with ALTIUS tinted contact lens wear, measured using a post-trial questionnaire. Participants will rate overall comfort, lens awareness, dryness, and ease of wear during daily activities. Higher scores indicate greater comfort and tolerability.
Time frame: 1 week after initiation of contact lens wear
Subjective Vision Quality with ALTIUS Tinted Contact Lenses
Participant assessment of visual quality while wearing ALTIUS tinted contact lenses, including clarity of vision, visual stability, and overall satisfaction with visual performance during routine activities. Responses will be collected using a study-specific questionnaire and compared descriptively with the participant's experience using tinted spectacles.
Time frame: 1 week after initiation of contact lens wear
Comparative Symptom Relief Preference
Participant-report comparison of symptom relief achieved with ALTIUS tinted contact lenses versus their habitual tinted spectacle lenses via subjective questionnaire. Specific questions include "In which situations did the Altius lenses help most" and "in which situation did the Altius lenses perform worse" than habitual tinted glasses. The choices included the following: bright outdoor environments, indoor lighting, computer use, driving, crowded or visually busy environments, sports or exercise, and none of the above. The subjects were also asked to indicate which option provided the best overall symptoms relief between tinted spectacles, Altius contact lens, and no preference.
Time frame: 1 week after initiation of contact lens wear
Tint Preference Evaluation
Assessment of participant satisfaction with the selected contact lens tint relative to their current spectacle tint. Subjects will answer the following question on a subjective questionnaire: how would you describe the brightness and comfort of the tint of your tinted contact lens: too light, just right, slighty too dark, and much too dark.
Time frame: 1 week after initiation of contact lens wear
Feasibility and Acceptance of Daily Disposable Tinted Contact Lens Wear
Evaluation of participant acceptance of daily disposable tinted contact lenses as a treatment option for post-concussion visual symptoms. Subjects will be asked the following questions in a subjective questionnaires. 1) "How likely are you to continue using Altius tinted contact lenses" with answers of: very unlikely, unlikely, unsure, likely, and very likely. 2) "How would you prefer to use the lenses moving forward" with answers of: regular daily wear, only during symptom flare-ups, only for bright environments, only for sports or special occasional, and prefer to stay with glasses only.
Time frame: 1 week after initiation of contact lens wear
Plan to share: No
Ran from May 2026 to primary completion in Jul 2026, 2 months.
Of 54 non-industry interventional studies with no phase under Post-Concussion Syndrome, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 58. This study's 2 months is below that.
Counting every sponsor, half of 56 studies reached it within 40 months; a quarter within 23 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Southern College of Optometry