Soft Bifocal Contact Lenses for Near-sightedness

(BLINK2 Trial)

Recruiting at 1 trial location

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Non-BLINK Study participants

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

248 Participants Needed

Trial Summary

What is the purpose of this trial?

This project intends to provide important, previously unmet answers regarding biological associations with myopia (nearsightedness) progression in order to improve the ability to predict patients who are most likely to benefit from myopia control, as well as questions frequently posed by patients and practitioners about the side effects, mechanism, and discontinuation of soft bifocal contact lens myopia control. The first three aims examine the association between biological variables that can be measured non-invasively and myopia progression, and they will be conducted regardless of the outcome of the currently in progress BLINK Study. The last three specific aims will be conducted if soft bifocal contact lenses slowed myopia progression by 30% or more in the BLINK Study, and they can be investigated with very few additional measurements.

Research Team

Jeffrey J Walline, OD PhD

Principal Investigator

The Ohio State University College of Optometry

Eligibility Criteria

This trial is for individuals who were part of the BLINK Study, focusing on those with near-sightedness (myopia). It aims to identify biological factors that could predict which patients will benefit most from myopia control using soft bifocal contact lenses.

Inclusion Criteria

Participants in the BLINK Study

Treatment Details

Interventions

• Soft Bifocal Contact Lens

Trial Overview The study tests if wearing soft bifocal contact lenses can slow down the worsening of near-sightedness. The research hinges on earlier findings; if prior results show a 30% improvement, this trial will explore additional benefits and mechanisms.

Participant Groups

Group I: Contact lens Experimental Treatment 1 Intervention

Depending upon the study lens proven to be the most effective in the BLINK Study, this contact lens will be used for the first two years of the study. The last year of the study, all subjects will be wearing single vision contact lenses.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

University of Houston

Collaborator

Trials

155

Recruited

48,600+