Post Concussion SymptomsNCT07869927
Evaluating Altius Tinted Contact Lenses as an Option Managing for Post-Concussion Visual Syndrome
A study testing ALTIUS® daily disposable performance-tinted contact lenses in people with Post Concussion Symptoms, run by Southern College of Optometry at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Concussion Symptoms
- What is being tested?
- ALTIUS® daily disposable performance-tinted contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2026to 29 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- History of concussion with ongoing visual symptoms consistent with post-concussion visual syndrome.
- Baseline BIVSS score ≥31.
- Currently using tinted spectacle lenses with self-reported symptom improvement.
- Eye examination within the previous year.
Who cannot join
- Refractive error outside the ALTIUS lens parameter range.
- Inability to safely handle, insert, or remove contact lenses.
- Active ocular disease contraindicating contact lens wear.
- History of contact lens intolerance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern College of Optometry
Memphis, Tennessee, 38104
About this study
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.
Read the detailed description
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.
- Conditions
- Post Concussion Symptoms
- Being tested
- ALTIUS® daily disposable performance-tinted contact lenses
- Keywords
- tint, contact lens
- Medical subject headings
- Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALTIUS® daily disposable performance-tinted contact lensesDevice
ALTIUS® daily disposable performance-tinted contact lenses of either Amber tint or Grey-Green tint, selected based on subject preference.
| Study group | Role | What they receive |
|---|---|---|
| Tinted contact lens | Experimental | 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. Receives: Device: ALTIUS® daily disposable performance-tinted contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after minimum of 1 week of tinted spectacle wear, and 1 week following initiation of ALTIUS tinted contact lens wear.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week after initiation of contact lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start27 May 2026
- Primary completion29 Jul 2026
- Study completion29 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Concussion SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm with within-subject comparison. 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yueren Wang, OD, Southern College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869927
- Sponsor's protocol ID
- SCO IRBtxm6133
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Altius Tinted Contact Lenses as an Option Managing for Post-Concussion Visual Syndrome
- ClinicalTrials.gov ID
- NCT07869927
- Acronym / sponsor ID
- SCO IRBtxm6133
- Conditions
- Post Concussion Symptoms
- Keywords
- tint, contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- 29 Jul 2026 (actual)
- Study completion
- 29 Jul 2026 (actual)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm with within-subject comparison. 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.
| Arm | Type | Receives |
|---|---|---|
| Tinted contact lens | Experimental | Device: ALTIUS® daily disposable performance-tinted contact lensesParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older.
- History of concussion with ongoing visual symptoms consistent with post-concussion visual syndrome.
- Baseline BIVSS score ≥31.
- Currently using tinted spectacle lenses with self-reported symptom improvement.
- Eye examination within the previous year.
Key exclusion criteria (4 listed)
- Refractive error outside the ALTIUS lens parameter range.
- Inability to safely handle, insert, or remove contact lenses.
- Active ocular disease contraindicating contact lens wear.
- History of contact lens intolerance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALTIUS® daily disposable performance-tinted contact lensesALTIUS® daily disposable performance-tinted contact lenses of either Amber tint or Grey-Green tint, selected based on subject preference. | Device | Tinted contact lens |
Primary outcome
Change in Brain Injury Vision Symptom Survey (BIVSS) Score
Time frame: Baseline, after minimum of 1 week of tinted spectacle wear, and 1 week following initiation of ALTIUS tinted contact lens wear.
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.
6 secondary outcomes
Participant Preference for Future Lens Use
Time frame: 1 week
Contact Lens Comfort Rating
Time frame: 1 week after initiation of contact lens wear
Subjective Vision Quality with ALTIUS Tinted Contact Lenses
Time frame: 1 week after initiation of contact lens wear
Comparative Symptom Relief Preference
Time frame: 1 week after initiation of contact lens wear
Tint Preference Evaluation
Time frame: 1 week after initiation of contact lens wear
Feasibility and Acceptance of Daily Disposable Tinted Contact Lens Wear
Time frame: 1 week after initiation of contact lens wear
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALTIUS® daily disposable performance-tinted contact lenses in people with Post Concussion Symptoms, run by Southern College of Optometry at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain Injury Vision Symptom Survey (BIVSS) Score (time frame: Baseline, after minimum of 1 week of tinted spectacle wear, and 1 week following initiation of ALTIUS tinted contact lens wear.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.