In-vivo Wettability Grading and Assessment Study (CIAN)

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: senofilcon A; Device: lotrafilcon B; Device: enfilcon A; Device: balafilcon A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01010555

P-368-C-104

Details and patient eligibility

About

The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.

Enrollment: 25 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• is at least 17 years of age
• has read and signed an information consent letter
• is a current daily wear contact lens wearer
• has acceptable fit with the study lenses
• has had an ocular exam in the last two years
• other protocol-defined inclusion criteria may apply

Exclusion criteria

• has any ocular disease
• has undergone corneal refractive surgery or is aphakic
• has any systemic disease affecting ocular health
• is pregnant or lactating
• other protocol-defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 4 patient groups

lotrafilcon B

Active Comparator group

Description:

Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.

Treatment:

Device: lotrafilcon B

balafilcon A

Active Comparator group

Description:

Balafilcon A contact lens randomly assigned to one eye, with lotrafilcon B contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.

Treatment:

Device: balafilcon A

senofilcon A

Active Comparator group

Description:

Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.

Treatment:

Device: senofilcon A

enfilcon A

Active Comparator group

Description:

Enfilcon A contact lens randomly assigned to one eye, with senofilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.

Treatment:

Device: enfilcon A