Prospective Evaluation of a Novel Multifocal Toric Daily Disposable Contact Lens in Presbyopic Adults with Astigmatism.

Purpose: To evaluate the clinical performance of a novel multifocal toric contact lens design combining a pupil-optimized multifocal design with a blink stabilized toric design featuring a single cylinder power and a choice of 3 add powers in a group of presbyopic patients with low to moderate astigmatism. Patients and Methods: A total of 171 subjects (105 myopic and 66 hyperopic) with refractive astigmatism of -1.00 diopter (D) to -1.75D with axes 90±15 or 180±15 degrees were fit with the study lenses in a two-week, multi-site prospective open-label clinical trial. The test lens was a multifocal toric soft contact lens with sphere powers of -1.00D to -4.00D and +1.00D to +4.50D, and a single cylinder power of -1.00D with axes 90±10 and 180±10 degrees. Outcome measures included logMAR Visual Acuity, subjective assessments of vision, comfort and handling, and fit metrics including orientation, rotational stability and fit success. Results: Over 96% of subjects were fit in the optimized lens power with 2 pairs of lenses or less. After 2-weeks of lens wear, the mean binocular high luminance high contrast (HLHC) logMAR visual acuities were -0.085, -0.023, and 0.083, for distance (4m), intermediate (64cm), and near (40cm), respectively. Subjective vision, comfort and handling scores established statistically higher scores for both hyperopes and myopes compared to the pre-defined margin. The percentage of eyes with absolute lens orientation error ≤10° was over 94% and rotational stability ≤5° was over 98%. Conclusion: The multifocal toric contact lens design provided clear and consistent vision for a variety of critical distance, intermediate and near tasks across varying lighting conditions and had a high rate of lens fit success.