In-vivo Wettability Grading and Assessment Study

NCT01010555 | Completed Results

• 1 other identifier: P-368-C-104
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• On-eye Wettability

  On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.

  4 weeks of wear

Study Arms (4)

lotrafilcon B

ACTIVE COMPARATOR

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.

Device: lotrafilcon B

balafilcon A

ACTIVE COMPARATOR

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.

Device: balafilcon A

senofilcon A

ACTIVE COMPARATOR

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.

Device: senofilcon A

enfilcon A

ACTIVE COMPARATOR

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.

Device: enfilcon A

Interventions

lotrafilcon B DEVICE

Commercially marketed, silicone hydrogel, spherical contact lens

Also known as: Air Optix

lotrafilcon B

balafilcon A DEVICE

Commercially marketed, silicone hydrogel, spherical contact lens

Also known as: PureVision

balafilcon A

senofilcon A DEVICE

Commercially marketed, silicone hydrogel, spherical contact lens

Also known as: Acuvue OASYS

senofilcon A

enfilcon A DEVICE

Commercially marketed, silicone hydrogel, spherical contact lens

Also known as: Avaira

enfilcon A

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• has any ocular disease
• has undergone corneal refractive surgery or is aphakic
• has any systemic disease affecting ocular health
• is pregnant or lactating

Sponsors & Collaborators

• CIBA VISION: lead
• University of Waterloo: collaborator

Study Sites (1)

Centre for Contact Lens Research: University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
• Organization: CIBA VISION

priya.janakiraman@cibavision.com

1-800-241-7629

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, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 10, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 10, 2012
• Results First Posted: May 30, 2011

Record last verified: 2012-01

Locations

CA (1)