Evaluation of Deposits on Contact Lenses Worn Daily Wear

Refractive Error Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725153
• Other study ID #: MS-006
• Status: Completed
• Phase: N/A
• First received: July 28, 2008
• Last updated: July 20, 2012
• Start date: March 2008
• Est. completion date: September 2008

Study information

• Verified date: July 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Balafilcon A contact lenses (PureVision)
Commercially marketed, soft contact lenses worn bilaterally for 10 hours
• Etafilcon A contact lenses (Acuvue2)
Commercially marketed, soft contact lenses worn bilaterally for 10 hours

Locations

Country	Name	City	State
United States	Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No