N/A
N=30
Kalifilcon A Toric Compared to Commercially Available Lenses
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT06098937 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Primary Gaze Orientation for 5 Minutes — 3.3; 2.8; 2.4; 3.6 degrees
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Kalifilcon Toric Lens (Device); Total1 for Astigmatism (Device); Precision1 for Astigmatism (Device); MyDay Toric (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Gaze Orientation for 5 Minutes |
3.3; 2.8; 2.4; 3.6 | — |
Summary
Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Have no active ocular disease or allergic conjunctivitis.
- Not be using any topical ocular medications.
- Be willing and able to follow instructions.
- Have signed a statement of informed consent.
Exclusion Criteria
- Participating in a conflicting study in the opinion of the Investigator.
- Considered by the Investigator to not be a suitable candidate for participation
Data sourced from ClinicalTrials.gov (NCT06098937). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.