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OpenTrials
Completed

NCT Number: NCT06751225

Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With Astigmatism

This open-label study is of adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.

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Key information

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

  • Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses)
  • Subjects must have 20/20 or better best corrected visual acuity.
  • 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 PI)
  • Ability to give informed consent
  • Willing to spend time for the study. Subjects will be required to attend three study visits and wear contact lenses on days between study visits.
  • Willing and able to wear contact lenses for at least 8 hours per day for 5 days per week during the study as daily wear.
  • Currently not using eye lubricating drops and willing to not use during study.
  • Either gender and 18-40 years of age.
  • Any racial or ethnic origin

Exclusion criteria

  • Any active ocular inflammation or infection.
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
  • Are presbyopic and require or habitually uses reading glasses for near work
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
  • History of refractive surgery
  • Meets the diagnosis of dry eye disease with OSDI screening score ≥13.
  • Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein
  • Is pregnant or lactating or planning a pregnancy during enrollment in the study
  • Is participating in another clinical research study that includes invasive ocular tests
  • An inability to perform contact lens application and removal after instruction.

Treatment and study plan

One week replacement soft contact lenses

Device

One week replacement soft contact lenses

Primary outcomes

  1. Subjective Assessment of Lens Wear Experience

    Time frame: After 3 weeks of lens wear

    VAS assessment of overall vision. (0-100 scale; 0=unacceptable 100=excellent)

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Jun 4, 2026

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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