Product Feasibility of a New Silicone Hydrogel Contact Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Investigational Lens; Device: Acuvue Oasys Lens; Device: Air Optix Aqua Lens

• Registration Number: NCT01309100
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Status Verified: 2014-03
• Results First Submitted: 2014-03-27
• Results First Submitted QC: 2014-03-27
• Last Update Submitted: 2014-03-27
• Results First Posted: 2014-04-29
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Subjects must have clear central corneas and be free of any anterior segment disorders.
• Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
• Subjects must be myopic and require lens correction

Exclusion Criteria

• Subjects with any systemic disease affecting ocular health.
• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Subjects with an active ocular disease or are using any ocular medication.
• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Investigational Lens	Investigational Lens	Bausch \& Lomb investigational silicone hydrogel lens.
Acuvue Oasys Lens	Acuvue Oasys Lens	Johnson \& Johnson Acuvue Oasys contact lens.
Air Optix Aqua Lens	Air Optix Aqua Lens	Ciba Vision Air Optix Aqua contact lens.

Primary Outcome Measures

Name	Time	Method
Visual Acuity (Investigational vs Air Optix Aqua Lens)	1 week	The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.
Visual Acuity (Investigational vs Acuvue Oasys Lens)	1 week	The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.

Secondary Outcome Measures

Name	Time	Method
Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)	1 week	The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.
Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)	1 week	The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.

Trial Locations

Locations (1)

Bausch & Lomb Incorporated; 🇺🇸 Rochester, New York, United States