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OpenTrials
Completed

NCT Number: NCT06172881

Novel Multifocal Soft Contact Lens Study

A single site, open label protocol will be used to evaluate the safety and quality of vision of a novel soft contact lens. Habitual contact lens wearers will be asked to come to the study site for one visit. Ocular health assessments and visual acuity will be completed with both the study lens and without.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to give informed consent
  • Any gender
  • Any racial or ethnic origin
  • 18 - 40 years of age
  • Distance visual acuity with best corrected visual acuity of 20/25 with each eye
  • Habitual soft contact lens wearer with myopia
  • Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the investigator).

Exclusion criteria

  • Current or active ocular inflammation or infection as determined by the Investigator.
  • Astigmatism > 0.75 D in either eye
  • History of previous eye surgery
  • Demonstration or history of corneal ectasia or keratoconus.
  • Pregnant or lactating.

Treatment and study plan

Investigational Contact Lens

Device

A soft contact lens that will be worn only at the study visit.

Primary outcomes

  1. Distance Visual Acuity

    Time frame: 1 day (This is a single visit study)

    LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Myoptechs

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2023
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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