NCT05829135

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2022

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2025

Completed
Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

2.1 years

First QC Date

August 25, 2022

Last Update Submit

June 16, 2025

Conditions

PhotophobiaVisual ImpairmentLow Vision

Outcome Measures

Primary Outcomes (1)

  • Glare test

    Measure visual acuity and contrast sensitivity with or without illumination source

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

Secondary Outcomes (1)

  • Visual Activities Questionnaire on Glare and Light sensitivity visual functions

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

Study Arms (1)

Treatment group

EXPERIMENTAL

All participants will be fit with Acuvue Oasys with Transitions.

Device: Acuvue Oasys with Transitions

Interventions

Acuvue Oasys with TransitionsDEVICE

soft contact lenses with darkening technology

Treatment group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nova Southeastern University

Davie, Florida, 33332, United States

Location

MeSH Terms

Conditions

PhotophobiaVision DisordersVision, Low

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • So Yeon Lee, OD

    Nova Southeastern University

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 25, 2022

First Posted

April 25, 2023

Study Start

May 1, 2023

Primary Completion

June 16, 2025

Study Completion

June 16, 2025

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)