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

NCT ID: NCT06751225

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-21
• Study Completion Date: 2025-12-31

Brief Summary

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Contact Lens Wear Experience

One week replacement soft contact lenses will be worn for 3 weeks.

Group Type: EXPERIMENTAL

One week replacement soft contact lenses

Intervention Type: DEVICE

One week replacement soft contact lenses

Interventions

One week replacement soft contact lenses

One week replacement soft contact lenses

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Fogt

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University College of Optometry

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Emma Grant

Role: CONTACT

grant.845@osu.edu

614-292-8858

Jennifer Fogt

Role: CONTACT

fogt.78@osu.edu

614-292-0882

Facility Contacts

Emma Grant

Role: primary

grant.845@osu.edu

614-292-8858

Other Identifiers

2024H0379

Identifier Type: -

Identifier Source: org_study_id