Evaluation of Deposits on Contact Lenses Worn Extended Wear

NCT00725530 | Completed Results

• 1 other identifier: MS-007
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.

Conditions

Myopia

Keywords

Lens deposits; Soft contact lens wearers

Outcome Measures

Primary Outcomes (1)

• Front Surface Lens Deposits

  Film and discrete deposits were assessed with a slit-lamp after 2-5 hours of open eye 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).

  7 days

Study Arms (2)

balafilcon A / etafilcon A

ACTIVE COMPARATOR

Balafilcon A worn first, with etafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.

Device: balafilcon A contact lens (PureVision); Device: etafilcon A contact lens (Acuvue2)

etafilcon A / balafilcon A

ACTIVE COMPARATOR

Etafilcon A worn first, with balafilcon A worn second. Each product worn bilaterally in an extended wear (overnight) basis for 7 days.

Device: balafilcon A contact lens (PureVision); Device: etafilcon A contact lens (Acuvue2)

Interventions

balafilcon A contact lens (PureVision) DEVICE

Commercially marketed, silicone hydrogel contact lens

Also known as: PureVision

balafilcon A / etafilcon A; etafilcon A / balafilcon A

etafilcon A contact lens (Acuvue2) DEVICE

Commercially marketed, hydrogel contact lens

Also known as: Acuvue2

balafilcon A / etafilcon A; etafilcon A / balafilcon A

Eligibility Criteria

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

You may qualify if:

• Age 18 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.

You may not qualify if:

• Evidence or history of ocular conditions as prescribed in the protocol.
• One functional eye or a monofit lens.
• Any slit-lamp finding score of (1) at the Screening Visit as defined by the protocol.
• Use of concomitant topical ocular prescription or over-the-counter ocular medications.
• History of seasonal allergies with significant ocular side effects.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director of Alcon Clinical
• Organization: Alcon Research, Ltd.

medinfo@alconlabs.com

888.451.3937; 817.568.6725

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: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 22, 2012
• Results First Posted: August 22, 2012

Record last verified: 2012-07

Locations

US (1)