Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions

NCT01252134 | Completed Results

• 1 other identifier: RDG10078 / SILVER
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Contact Lens Wear

Keywords

Soft Contact lens; Multi-purpose solution; Wettability

Outcome Measures

Primary Outcomes (1)

• Ex Vivo Contact Angle

  Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.

  8 hours

Secondary Outcomes (3)

• Subjective Comfort

  8 hours

• Corneal Staining Type

  8 hours

• Corneal Staining Extent

  8 hours

Study Arms (6)

Synergi, then Biotrue, then OTE

OTHER

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.

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

Synergi, then OTE, then Biotrue

OTHER

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.

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

Biotrue, then OTE, then Synergi

OTHER

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.

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

Biotrue, then Synergi, then OTE

OTHER

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.

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

OTE, then Biotrue, then Synergi

OTHER

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.

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

OTE, then Synergi, then Biotrue

OTHER

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.

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

Interventions

Biotrue multipurpose solution DEVICE

Contact lens care solution

Biotrue, then OTE, then Synergi; Biotrue, then Synergi, then OTE; OTE, then Biotrue, then Synergi; OTE, then Synergi, then Biotrue; Synergi, then Biotrue, then OTE; Synergi, then OTE, then Biotrue

Sauflon Synergi multipurpose solution DEVICE

Contact lens care solution

Biotrue, then OTE, then Synergi; Biotrue, then Synergi, then OTE; OTE, then Biotrue, then Synergi; OTE, then Synergi, then Biotrue; Synergi, then Biotrue, then OTE; Synergi, then OTE, then Biotrue

OTE Elements multipurpose solution DEVICE

Contact lens care solution

Biotrue, then OTE, then Synergi; Biotrue, then Synergi, then OTE; OTE, then Biotrue, then Synergi; OTE, then Synergi, then Biotrue; Synergi, then Biotrue, then OTE; Synergi, then OTE, then Biotrue

Silicone hydrogel contact lenses (Acuvue Advance) DEVICE

Commercially marketed contact lenses

Also known as: Acuvue® Advance™

Biotrue, then OTE, then Synergi; Biotrue, then Synergi, then OTE; OTE, then Biotrue, then Synergi; OTE, then Synergi, then Biotrue; Synergi, then Biotrue, then OTE; Synergi, then OTE, then Biotrue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcon Research: lead

Results Point of Contact

• Title: Director of Medical Affairs
• Organization: Alcon Research, Ltd.

medinfo@alconlabs.com

888.451.3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 2, 2010
• Study Start: November 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: June 11, 2012
• Results First Posted: June 11, 2012

Record last verified: 2012-05