Contact Lens Trial Fitting Experience

Assessment of a Novel Multifocal Contact Lens Trial Fitting Experience

This study will assess a trial fitting experience with contact lenses.

Study Overview

• Status: Not yet recruiting
• Conditions: Presbyopia
• Intervention / Treatment: Device: Lens A ( stenfilcon A )

Detailed Description

This study is designed to evaluate a contact lens fitting experience utilizing an at home trial kit.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly Voltz; Phone Number: +19256604364; Email: KVoltz@coopervision.com

Study Locations

• United States
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Family Eye Care
      • Contact: Sarah Maldonado; Phone Number: 7136648087; Email: sarah@BFRYR.COM
    • Corpus Christi, Texas, United States, 78411
      • Drs. Mcintyre Garza Avila & Jurica
      • Contact: Alissa Shawver; Phone Number: 3619940310; Email: alissa@cccontacts.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. They are at least 40 years of age.
2. They understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent.
3. They habitually wear MyDay sphere or MyDay Energys contact lenses (including sphere lenses for monovision, or sphere lenses for distance vision correction and spectacles for near vision correction).
4. They have a minimum reading add of +0.75DS (based on their manifest refraction) and no more than +2.50DS.
5. They have spherical equivalent refractive error between +4.50 to -11.00DS (some restrictions apply based on near add availability)
6. They have refractive astigmatism of no greater than 0.75DC in each eye.
7. They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye with manifest refraction.
8. They report at least one near-vision difficult symptom consistent with presbyopia as evidenced by a response of 'slight difficult' or worse on ³ 1 item of the Near Activity Visual Questionnaire (NAVQ-P) at screening.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research trial.
2. They have an ocular disorder which would normally contraindicate contact lens wear.
3. They have a systemic disorder which would normally contraindicate contact lens wear.
4. They are pseudophakic or aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
8. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A ( stenfilcon A); All participants will wear lens A	Device: Lens A ( stenfilcon A ); 15 minutes of daily wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Lens Fitting Experience	Participant's readiness to finalize a multifocal contact lens prescription after using an at home trial kit based on a scale of 1- 5 (1 - Good and 5 - Bad).	At the End of 15 minutes of daily wear

Collaborators and Investigators

• Sponsor: CooperVision International Limited (CVIL)

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: CV-26-18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes