Not yet recruiting NCT07557030
Optimization for Toric Contact Lenses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lens 1 ( stenfilcon A ), Lens 2 ( comfilcon A ).
- Who it may be relevant to
- Registry conditions: Astigmatism, Ametropia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Lens 1 ( stenfilcon A )
15 minutes of daily wear - Device Lens 2 ( comfilcon A )
15 minutes of daily wear
Primary outcome measures
- Subjective assessment of optimization of Toric lenses [Time frame: At the End of Baseline 15 minutes of daily wear]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Indiana University — Bloomington
Identifiers
NCT: NCT07557030 · CV-26-17