Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels

Alcon

Status: Completed

Conditions: Contact Lenses

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00940459

M-09-11

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 5 patient groups

Acuvue Oasys

Experimental group

Description:

One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.

Treatment:

Device: Contact lens care system (EasySept)

Device: Senofilcon A contact lens (Acuvue Oasys)

Biofinity

Experimental group

Description:

One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.

Treatment:

Device: Comfilcon A contact lens (Biofinity)

Device: Contact lens care system (EasySept)

Air Optix

Experimental group

Description:

One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.

Treatment:

Device: Contact lens care system (EasySept)

Device: Lotrafilcon B contact lens (Air Optix)

PureVision

Experimental group

Description:

One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.

Treatment:

Device: Balafilcon A contact lens (PureVision)

Device: Contact lens care system (EasySept)

Acuvue 2

Active Comparator group

Description:

One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.

Treatment:

Device: Contact lens care system (EasySept)

Device: Etafilcon A contact lens (Acuvue 2)