N/A
Completed N=66
Comparison of Clinical Performance of Two Monthly Replacement Toric Soft Contact Lenses
ametropia · Astigmatism
Source: ClinicalTrials.gov NCT06165627 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Mean Distance Visual Acuity With Study Lenses at Day 30 — -0.07; -0.06 logMAR
Summary
The purpose of this study is to assess the clinical performance of TOTAL30 for Astigmatism (T30fA) soft contact lenses with Biofinity Toric soft contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Distance Visual Acuity With Study Lenses at Day 30 |
-0.07; -0.06 | — |
Eligibility Criteria
Key Inclusion Criteria
- Successful wearer of toric soft contact lenses in both eyes for a minimum of 5 days per week and at least 12 hours per day during the past 3 months;
- Best corrected distance visual acuity (as determined by manifest refraction at screening) better than or equal to 0.10 logMAR in each eye;
- Willing and able to wear the study lenses as specified in the protocol;
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria
- Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or corneal vascularization that is mild (Grade 2) or higher; presence of corneal infiltrates;
- Monovision and multifocal contact lens wearers;
- Habitual Biofinity Toric soft contact lens wearers, daily disposable contact lens wearers, and Alcon Toric contact lens wearers in the past 3 months prior to consent;
- Wearing habitual contact lenses in extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT06165627). 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. Informational only — not medical advice.