Evaluation of a weekly replacement soft contact lens for new wearers with astigmatism
Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With Astigmatism
This study tests a new weekly contact lens for adults with astigmatism who are trying contacts for the first time to see how comfortable and easy they are to use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06751225 on ClinicalTrials.gov |
What this trial studies
This open-label study focuses on adults with astigmatism who have never worn contact lenses before. Participants will be fitted with a one-week planned-replacement soft contact lens and will wear them for approximately three weeks. Throughout the study, subjects will return for vision and lens fit assessments and complete surveys regarding their wear experience. The goal is to evaluate the comfort and usability of the lenses in this specific population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-40 with astigmatism of -0.75 or greater who have never worn contact lenses.
Not a fit: Patients with active ocular inflammation or infection, or those with systemic conditions that could confound the data, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the experience of new contact lens wearers with astigmatism, leading to better vision correction options.
How similar studies have performed: While this approach is not widely tested, similar studies on contact lens wear experiences have shown positive outcomes in improving comfort and usability.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: 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.
Where this trial is running
Columbus, Ohio
- The Ohio State University College of Optometry — Columbus, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Emma Grant
- Email: grant.845@osu.edu
- Phone: 614-292-8858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.