Feasibility of a New Silicone Hydrogel Lens

Not Applicable

Completed

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

• Registration Number: NCT01131130
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft contact lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2014-03
• Results First Submitted: 2014-03-28
• Results First Submitted QC: 2014-03-28
• Last Update Submitted: 2014-03-28
• Results First Posted: 2014-04-30
• Last Update Posted: 2014-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Participants must have clear central corneas and be free of any anterior segment disorders.
• Participants 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.
• Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.

Exclusion Criteria

• Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
• Participants with any systemic disease affecting ocular health.
• Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Participants with an active ocular disease or are using any ocular medication.
• Participants who have had any corneal surgery (eg, refractive surgery).
• Participants who are allergic to any component in the study care products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Investigational contact lens	Investigational contact lens	Bausch \& Lomb
Acuvue Oasys Contact Lens	Acuvue Oasys Contact Lens	Johnson \& Johnson Lens
Air Optix Aqua	Air Optix Aqua	Ciba Vision

Primary Outcome Measures

Name	Time	Method
Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens	7 days	Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Comfort Throughout the Day - Test Lens vs. Acuvue Oasys	7 days	Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.

Secondary Outcome Measures

Name	Time	Method
Lens Wettability, Test Lens vs. Acuvue Oasys	7 days	Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas \> 0.5 mm in size).
Lens Wettability, Test Lens vs. Air Optix Aqua	7 days	Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas \> 0.5 mm in size).

Trial Locations

Locations (1)

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