Optimization for Toric Contact Lenses

The aim of this study is to evaluate the agreement between subjective and objective toric lens prescriptions.

Study Overview

• Status: Not yet recruiting
• Conditions: Astigmatism; Ametropia
• Intervention / Treatment: Device: Lens 1 ( stenfilcon A ); Device: Lens 2 ( comfilcon A )

Detailed Description

To evaluate agreement between subjective and objective optimized toric contact lens prescriptions.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. They are at least 18 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 have spherical refractive error at the corneal plane between +4.00 to -7.00DS
4. They have refractive astigmatism at the corneal plane of 0.75 to 2.25DC in one eye.
5. They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye
6. They are a current soft contact lens wearer or have previous experience of successful soft contact lens wear in the past 3 years.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research trial.
2. They have an ocular disorder which would normally contra-indicate contact lens wear.
3. They have a systemic disorder which would normally contra-indicate 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens 1 ( stenfilcon A); All participants will be randomized to wear lens A	Device: Lens 1 ( stenfilcon A ); 15 minutes of daily wear
Experimental: Lens 2 ( comfilcon A); All participants will be randomized to wear lens B	Device: Lens 2 ( comfilcon A ); 15 minutes of daily wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective assessment of optimization of Toric lenses	Proportion of eyes in which the optimized toric lens cylinder axis determined by the subjective method agrees with that determined by the objective method within ±10 degrees (measured at a single time point).	At the End of Baseline 15 minutes of daily wear

Collaborators and Investigators

• Sponsor: CooperVision International Limited (CVIL)
• Collaborators: Indiana University

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Astigmatism; Refractive Errors
• Other Study ID Numbers: CV-26-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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