PhotophobiaNCT05829135
Improving Glare and Visual Comfort for Patients With Visual Impairment
A study testing Acuvue Oasys with Transitions in people with Photophobia and Visual Impairment, run by Nova Southeastern University at 1 site in United States.
Trial summary
To assess the use of contact lenses with transitions technology to improve glare, light sensitivity and overall visual comfort in patients with visual impairment. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Photophobia, Visual Impairment, Low Vision
- What is being tested?
- Acuvue Oasys with Transitions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 16 Jun 2025
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to give informed consent
- Able to speak and read English
- Experience glare and light sensitivity that impacts patient's daily living activities
- Have confirmed diagnosis of ocular condition including but not limited to Stargardt's, Cone dystrophy, Cone-rod dystrophy, Albinism, Retinitis Pigmentosa and Achromatopsia.
- Willing and able to wear the contact lenses as instructed
Who cannot join
- Are pregnant, nursing or planning to become pregnant during the course of the study
- Have current/recent ocular infection, inflammation, surgery in the past 3 months that contraindicates contact lens wear
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Managing Visual Comfort and Function in Patients With Low Vision Using Acuvue Oasys
To assess the use of contact lenses with transitions technology to improve glare, light sensitivity and overall visual comfort in patients with visual impairment.
Read the detailed description
Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology can adapt to the amount of visible light in the environment, darkening the lenses in bright sunlight, and returning to regular tint in normal or dim environment.
Purpose of this study is to assess whether individuals with visual impairment may benefit from these lenses to minimize glare, light sensitivity symptoms and improve the overall visual comfort.
- Conditions
- Photophobia, Visual Impairment, Low Vision
- Being tested
- Acuvue Oasys with Transitions
- Medical subject headings
- Photophobia, Vision Disorders, Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acuvue Oasys with TransitionsDevice
soft contact lenses with darkening technology
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | All participants will be fit with Acuvue Oasys with Transitions. Receives: Device: Acuvue Oasys with Transitions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glare test
Measure visual acuity and contrast sensitivity with or without illumination source
Measured: Measure change from baseline at the 6 week follow-up visit
Secondary outcomes (1)
Visual Activities Questionnaire on Glare and Light sensitivity visual functions
Patient will rate 7 questions on scale ranges from 1-5, higher score indicates more symptoms related to glare and light sensitivity during daily living tasks. Max value 35
Measured: Measure change from baseline at the 6 week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 May 2023
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Why it stopped: contact lens no longer available for study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PhotophobiaStudies 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Optometry
- Responsible party
- Principal investigator, So Yeon Lee, Nova Southeastern University
- Investigators
- So Yeon Lee, OD, Study chair, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829135
- Sponsor's protocol ID
- 2020-128
- Status last verified
- Jun 2025
- First submitted
- 25 Aug 2022
- Last updated
- 19 Jun 2025
- 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 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Visual Comfort and Function in Patients With Low Vision Using Acuvue Oasys
- ClinicalTrials.gov ID
- NCT05829135
- Acronym / sponsor ID
- 2020-128
- Conditions
- Photophobia, Visual Impairment, Low Vision
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: contact lens no longer available for study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- American Academy of Optometry
- Study start
- 1 May 2023 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 25 Apr 2023 (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.
To assess the use of contact lenses with transitions technology to improve glare, light sensitivity and overall visual comfort in patients with visual impairment.
Detailed description
Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology can adapt to the amount of visible light in the environment, darkening the lenses in bright sunlight, and returning to regular tint in normal or dim environment.
Purpose of this study is to assess whether individuals with visual impairment may benefit from these lenses to minimize glare, light sensitivity symptoms and improve the overall visual comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Acuvue Oasys with TransitionsAll participants will be fit with Acuvue Oasys with Transitions. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ability to give informed consent
- Able to speak and read English
- Experience glare and light sensitivity that impacts patient's daily living activities
- Have confirmed diagnosis of ocular condition including but not limited to Stargardt's, Cone dystrophy, Cone-rod dystrophy, Albinism, Retinitis Pigmentosa and Achromatopsia.
- Willing and able to wear the contact lenses as instructed
Key exclusion criteria (2 listed)
- Are pregnant, nursing or planning to become pregnant during the course of the study
- Have current/recent ocular infection, inflammation, surgery in the past 3 months that contraindicates contact lens wear
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 |
|---|---|---|
| Acuvue Oasys with Transitionssoft contact lenses with darkening technology | Device | Treatment group |
Primary outcome
Glare test
Time frame: Measure change from baseline at the 6 week follow-up visit
Measure visual acuity and contrast sensitivity with or without illumination source
1 secondary outcome
Visual Activities Questionnaire on Glare and Light sensitivity visual functions
Time frame: Measure change from baseline at the 6 week follow-up visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- 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.
So Yeon Lee, OD study chair
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acuvue Oasys with Transitions in people with Photophobia and Visual Impairment, run by Nova Southeastern University 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 2 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: withdrawn, as of the sponsor's last update on 19 Jun 2025. 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 was withdrawn before enrolling participants, so there are no results.
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?
Glare test (time frame: Measure change from baseline at the 6 week follow-up visit). 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 19 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.