NCT01058629

Study to Evaluate the Clinical Performance of SynergEyes A2 Hybrid Contact Lenses

A 180 Day, Multicenter Study to Evaluate the Clinical Performance of SynergEyes A2 Hybrid Contact Lenses for Daily Wear Use in the Correction of Refractive Error With or Without Astigmatism in Non-diseased Eyes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: SynergEyes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter study to evaluate the clinical performance of the SynergEyes A2 lens in patients with refractive errors with or without astigmatism.

Detailed description

Hybrid contact lenses have been previously shown to be a safe and effective method to correct refractive errors with and without astigmatism. The hybrid contact lens design may provide greater visual acuity and comfort than other soft or rigid gas permeable (RGP) lenses currently available. The purpose of this study is to confirm the design of the SynergEyes A2 lens by evaluating clinical performance and, if necessary, modify certain lens parameters in order to optimize lens performance. Objective and subjective parameters will be used to evaluate the lens.

Conditions

• Refractive Errors
• Astigmatism

Interventions

Type	Name	Description
DEVICE	SynergEyes A2 Hybrid Contact Lens	SynergEyes A2 is a hybrid contact lens cleared by the US Food and Drug Administration (FDA) for daily wear correction of up to +20.00 and -20.00 in eyes with astigmatism up to 6.00D and for presbyopia.

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-01-28
• Last updated: 2010-08-25

Locations

10 sites across 1 country: United States