ClinicalTrials.gg
WithdrawnNCT05829135Updated Jun 19, 2025

Improving Glare and Visual Comfort for Patients With Visual Impairment

An interventional study of Acuvue Oasys with Transitions in Photophobia, Visual Impairment and Low Vision, sponsored by Nova Southeastern University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-06-19.

Sponsored by Nova Southeastern University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
contact lens no longer available for study
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Photophobia
  • Visual Impairment
  • Low Vision
03

In context

Photophobia

43 studies on the registry are indexed under Photophobia; 13 are open to participants now.

Browse Photophobia studies →

Lead sponsor

Nova Southeastern University is the lead sponsor of 80 studies on the registry; 18 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Ability to give
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Treatment group

    All participants will be fit with Acuvue Oasys with Transitions.

    Device: Acuvue Oasys with Transitions

Interventions

  • DeviceAcuvue Oasys with Transitions

    soft contact lenses with darkening technology

06

What researchers measure

Primary outcomes

  1. Glare test

    Measure visual acuity and contrast sensitivity with or without illumination source

    Time frame: 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

    Time frame: Measure change from baseline at the 6 week follow-up visit

07

Study locations

1 site
  • Nova Southeastern University
    Davie, Florida 33332, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05829135
Lead sponsor
Nova Southeastern University
Collaborators
American Academy of Optometry
Responsible party
So Yeon Lee (Assistant professor, Nova Southeastern University) — Principal investigator
First posted
Apr 25, 2023
Start date
May 1, 2023
Primary completion
Jun 16, 2025
Completion
Jun 16, 2025
Last update
Jun 19, 2025

Study contacts

So Yeon Lee, OD
study chair · Nova Southeastern University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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