Optimization for Toric Contact Lenses
1 other identifier
interventional
45
1 country
1
Brief Summary
The aim of this study is to evaluate the agreement between subjective and objective toric lens prescriptions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2026
CompletedFirst Posted
Study publicly available on registry
April 29, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
May 6, 2026
May 1, 2026
3 months
April 23, 2026
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Lens 1 ( stenfilcon A)
EXPERIMENTALAll participants will be randomized to wear lens A
Lens 2 ( comfilcon A)
EXPERIMENTALAll participants will be randomized to wear lens B
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CooperVision International Limited (CVIL)lead
- Indiana Universitycollaborator
Study Sites (1)
Indiana University
Bloomington, Indiana, 47405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2026
First Posted
April 29, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share