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

Description

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.

Conditions

Astigmatism Bilateral

Study Overview

Study Details

Study overview

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.

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

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

Condition
Astigmatism Bilateral
Intervention / Treatment

-

Contacts and Locations

Columbus

The Ohio State University College of Optometry, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses)
  • 2. Subjects must have 20/20 or better best corrected visual acuity.
  • 3. 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)
  • 4. Ability to give informed consent
  • 5. 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.
  • 6. 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.
  • 7. Currently not using eye lubricating drops and willing to not use during study.
  • 8. Either gender and 18-40 years of age.
  • 9. Any racial or ethnic origin
  • 1. Any active ocular inflammation or infection.
  • 2. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
  • 3. Are presbyopic and require or habitually uses reading glasses for near work
  • 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
  • 5. History of refractive surgery
  • 6. Meets the diagnosis of dry eye disease with OSDI screening score ≥13.
  • 7. Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein
  • 8. Is pregnant or lactating or planning a pregnancy during enrollment in the study
  • 9. Is participating in another clinical research study that includes invasive ocular tests
  • 10. An inability to perform contact lens application and removal after instruction.

Ages Eligible for Study

18 Years to 40 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Ohio State University,

Study Record Dates

2025-12-31