Comparison of clinical performance of a Silicone Hydrogel Dual-Focus Myopia Control Soft Contact Lens with a Currently Marketed Myopia Control Lens

Lee Hall¹, Ayeswarya Ravikumar¹, Jill Woods², Amir Moezzi², Dawn Meyer³, Martin Ricket³, Pete Kollbaum³

¹CooperVision Inc., Pleasanton, CA
²CORE, Waterloo,
³CORL, Indiana University
 

Purpose: 
To compare the clinical performance of a silicone hydrogel 1-day (SiHy1d) dual-focus myopia control design soft contact lens (SCL) (stenfilcon A) with a currently marketed and proven hydrogel 1-day (Hy1d) myopia control SCL (omafilcon A), both utilising the same myopia control optics. 
 

Methods: 
A prospective, multisite, double-masked, randomised 1-week bilateral crossover study, comparing SiHy1d against Hy1d. Existing myopic SCL wearing children, aged 8-18 years, spherical refractive error (SRE) between -0.75DS and -7.00DS and ≤-0.75DC astigmatism in each eye, were eligible to participate. Primary and secondary outcome measures were binocular distance high contrast visual acuity (BHCVA) and vision quality (0-100 Visual Analog Scale, VAS, 100=’very good’). Other outcomes were comfort (0-100 VAS scale); lens fit; lens surface wettability (0-4 scale, 0=’excellent’) and end-of-study preferences for comfort, vision and ‘overall’ preference (5-point Likert scale). Ocular health was also assessed (0-4 scales, 0=’normal’).
 

Results:
Thirty-two children (mean ±SD: 15.6 ±2.4 years, female [62.5%]) were randomised (mean ±SD SRE:  -2.56 ±1.43DS). Average BHCVAs were the same both lenses (mean ±SD logMAR: -0.14 ±0.05 vs. -0.14 ±0.07; p=0.56) and vision quality ratings were slightly, but not significantly higher for the SiHy1d lens (mean ±SD: 89.2 ±8.5 vs. 86.5 ±14.3, p=0.22). Comfort ratings were comparable between the two lenses (mean ±SD: 90.2 ±8.9 vs. 86.3 ±15.0; p=0.174). All lenses showed acceptable lens movement and lens centration relative to the limbus. Lens wettability ratings were comparable and not statistically significantly different between lenses (mean ±SD: 1.10 ± 0.61 vs. 1.20 ±0.72, p=0.46). A greater proportion of subjects strongly preferred the SiHy1d for vision, comfort and ‘overall’ preference, the latter two of which were statistically significant (19% vs.3%, p= 0.02, for both). Ocular results were all of low grade.
 

Conclusion: 
The SiHy1D lens showed comparable clinical performance to the existing omafilcon A Hy1d dual-focus myopia control SCL. 
 

Disclosures:  
Study was carried out by Centre for Ocular Research University of Waterloo and Clinical Optics Research Lab Indiana University, supported by CooperVision, Inc.   Lee Hall and Ayeswarya Ravikumar are employees of CooperVision.