Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions (SILVER)

Alcon

Status: Completed

Conditions: Contact Lens Wear

Treatments: Device: Sauflon Synergi multipurpose solution; Device: Biotrue multipurpose solution; Device: Silicone hydrogel contact lenses (Acuvue Advance); Device: OTE Elements multipurpose solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01252134

RDG10078 / SILVER

Details and patient eligibility

About

The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age
• Soft contact lens wear on a daily wear basis
• Able to wear lenses at least 8 hours
• Generally healthy with normal ocular health
• Other protocol-defined inclusion criteria may apply

Exclusion criteria

• Use of additional lens cleaners
• Known sensitivities to any ingredient in any of the study products
• History of ocular surgery/trauma within the last 6 months
• 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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22 participants in 6 patient groups

Synergi, then Biotrue, then OTE

Other group

Description:

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Treatment:

Device: Silicone hydrogel contact lenses (Acuvue Advance)

Device: OTE Elements multipurpose solution

Device: Biotrue multipurpose solution

Device: Sauflon Synergi multipurpose solution

Synergi, then OTE, then Biotrue

Other group

Description:

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Treatment:

Device: Silicone hydrogel contact lenses (Acuvue Advance)

Device: OTE Elements multipurpose solution

Device: Biotrue multipurpose solution

Device: Sauflon Synergi multipurpose solution

Biotrue, then OTE, then Synergi

Other group

Description:

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Treatment:

Device: Silicone hydrogel contact lenses (Acuvue Advance)

Device: OTE Elements multipurpose solution

Device: Biotrue multipurpose solution

Device: Sauflon Synergi multipurpose solution

Biotrue, then Synergi, then OTE

Other group

Description:

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Treatment:

Device: Silicone hydrogel contact lenses (Acuvue Advance)

Device: OTE Elements multipurpose solution

Device: Biotrue multipurpose solution

Device: Sauflon Synergi multipurpose solution

OTE, then Biotrue, then Synergi

Other group

Description:

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Treatment:

Device: Silicone hydrogel contact lenses (Acuvue Advance)

Device: OTE Elements multipurpose solution

Device: Biotrue multipurpose solution

Device: Sauflon Synergi multipurpose solution

OTE, then Synergi, then Biotrue

Other group

Description:

Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.

Treatment:

Device: Silicone hydrogel contact lenses (Acuvue Advance)

Device: OTE Elements multipurpose solution

Device: Biotrue multipurpose solution

Device: Sauflon Synergi multipurpose solution