NCT07557030Not yet recruitingNot Applicable
Optimization for Toric Contact Lenses
CooperVision International Limited (CVIL)1 site in 1 country45 target enrollmentStarted: May 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Subjective assessment of optimization of Toric lenses
Study Overview
Brief Summary
The aim of this study is to evaluate the agreement between subjective and objective toric lens prescriptions.
Detailed Description
To evaluate agreement between subjective and objective optimized toric contact lens prescriptions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •They are at least 18 years of age.
- •They understand their rights as a research participant and are willing and able to sign a Statement of Informed Consent.
- •They have spherical refractive error at the corneal plane between +4.00 to -7.00DS
- •They have refractive astigmatism at the corneal plane of 0.75 to 2.25DC in one eye.
- •They are able to achieve distance HCHL visual acuity of +0.10 logMAR or better in each eye
- •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
- •Is participating in any concurrent clinical or research trial.
- •They have an ocular disorder which would normally contra-indicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are pseudophakic or aphakic.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
Arms & Interventions
Lens 1 ( stenfilcon A)
Experimental
All participants will be randomized to wear lens A
Intervention: Lens 1 ( stenfilcon A ) (Device)
Lens 2 ( comfilcon A)
Experimental
All participants will be randomized to wear lens B
Intervention: Lens 2 ( comfilcon A ) (Device)
Outcomes
Primary Outcomes
Subjective assessment of optimization of Toric lenses
Time Frame: At the End of Baseline 15 minutes of daily wear
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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