Evaluation of Deposits on Contact Lenses Worn Daily Wear

NCT00725153 | Completed Results

• 1 other identifier: MS-006
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to measure front surface deposits on contact lenses when worn for ten hours.

Conditions

Refractive Error

Keywords

Contact lens deposits; Soft contact lenses; Myopia

Outcome Measures

Primary Outcomes (1)

• Front Surface Lens Deposits

  Film and discrete deposits were assessed with a slit-lamp after 10 hours of lens wear. Film deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=slight, deposition occupying 1-5% of lens front surface; 2=mild, deposition occupying 6-15% of lens front surface; 3=moderate, deposition occupying 16-25% of lens front surface; 4=severe, deposition occupying \>25% of lens front surface. Discrete deposits were recorded on a 5-point scale, where 0=no deposition, clean surface; 1=microdeposits (less than or equal to 10 dots); 2=microdeposits (greater than 10 dots); 3=macro deposits; 4=one or more jelly bumps. Participants were classified into Front Surface Lens Deposits \<2 (less than grade 2 for both film and discrete) and into front surface lens deposits \>1 (greater than grade 1 for either film, discrete, or both).

  10 hours

Study Arms (2)

PureVision/Acuvue 2

OTHER

PureVision contact lenses worn first, with Acuvue 2 contact lenses worn second. Both products worn for 10 hours each.

Device: Balafilcon A contact lenses (PureVision); Device: Etafilcon A contact lenses (Acuvue2)

Acuvue 2/PureVision

OTHER

Acuvue 2 contact lenses worn first, with PureVision contact lenses worn second. Both products worn for 10 hours each.

Device: Balafilcon A contact lenses (PureVision); Device: Etafilcon A contact lenses (Acuvue2)

Interventions

Etafilcon A contact lenses (Acuvue2) DEVICE

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Also known as: Acuvue2

Acuvue 2/PureVision; PureVision/Acuvue 2

Balafilcon A contact lenses (PureVision) DEVICE

Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Also known as: PureVision

Acuvue 2/PureVision; PureVision/Acuvue 2

Eligibility Criteria

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

You may qualify if:

• years or older.
• Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with contact lenses.
• Successfully wearing hydrogel or silicone hydrogel contact lenses prior to enrollment in the study.

You may not qualify if:

• Evidence or history of keratitis (dendritic keratitis); viral disease of the cornea and/or conjunctiva; acute bacterial disease of the cornea and/or conjunctiva and/or eyelids; infection of the eye; and/or fungal disease of the eye.
• One functional eye or a monofit lens.
• Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis.
• Any slit-lamp finding score of (1) at the Screening Visit as defined in protocol.
• Use of concomitant topical ocular prescription or over-the-counter (OTC) ocular medications.
• History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Refractive Errors; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Jessie Lemp, MS
• Organization: Alcon Research, Ltd.

Jessie.Lemp@alconlabs.com

817-615-2739

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: March 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 23, 2012
• Results First Posted: August 23, 2012

Record last verified: 2012-07

Locations

US (1)