Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

Not Applicable

Completed

• Conditions: Contact Lenses
• Interventions: Device: Lotrafilcon B contact lens (Air Optix); Device: Balafilcon A contact lens (PureVision); Device: Senofilcon A contact lens (Acuvue Oasys); Device: Etafilcon A contact lens (Acuvue 2); Device: Comfilcon A contact lens (Biofinity); Device: Contact lens care system (EasySept)

• Registration Number: NCT00940459
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-15
• Study First Posted: 2009-07-16
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2012-07
• Last Update Submitted: 2016-11-15
• Last Update Posted: 2016-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Minimum age of 18 years old
• Adapted contact lens wearer
• Sign informed consent
• Normal eyes with the exception of the need for visual correction
• Astigmatism less than or equal to -0.75 diopter
• Spherical prescription range between -10.00 and +6.00 diopters
• Other protocol-defined inclusion criteria may apply

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Exclusion Criteria

• Any known sensitivity to the test articles used in the study
• Monocular vision
• Lid or conjunctival infections or abnormalities
• Conjunctival staining greater than Grade 1
• Corneal staining greater than Grade 2
• Corneal edema or opacifications
• Aphakia
• Any previous corneal surgery
• Iritis
• Recent significant changes in visual acuity
• Ocular disease that contraindicates contact lens wear
• Tarsal abnormalities greater than Grade 2
• Any ophthalmic medication
• Any systemic medication or condition that might affect the subject's participation in the study
• Chronic upper respiratory infections or colds
• Pregnancy or planning to become pregnant
• Lactation
• Seasonal allergies
• Known infections or immunosuppressive disease
• Participation in other studies
• Other protocol-defined exclusion criteria may apply

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Biofinity	Contact lens care system (EasySept)	One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Air Optix	Lotrafilcon B contact lens (Air Optix)	One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
PureVision	Balafilcon A contact lens (PureVision)	One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Acuvue Oasys	Senofilcon A contact lens (Acuvue Oasys)	One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Air Optix	Contact lens care system (EasySept)	One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
PureVision	Contact lens care system (EasySept)	One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Acuvue 2	Etafilcon A contact lens (Acuvue 2)	One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Biofinity	Comfilcon A contact lens (Biofinity)	One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Acuvue Oasys	Contact lens care system (EasySept)	One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
Acuvue 2	Contact lens care system (EasySept)	One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.

Primary Outcome Measures

Name	Time	Method
Circumlimbal Conjunctival Staining (CCS)	After 10 days of wear

Trial Locations

Locations (1)

Optometric Technology Group Ltd; 🇬🇧 London, United Kingdom