Evaluation of Deposits on Contact Lenses Worn Extended Wear

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725530
• Other study ID #: MS-007
• Status: Completed
• Phase: N/A
• First received: July 28, 2008
• Last updated: July 19, 2012
• Start date: March 2008
• Est. completion date: October 2008

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• 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.

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• balafilcon A contact lens (PureVision)
Commercially marketed, silicone hydrogel contact lens
• etafilcon A contact lens (Acuvue2)
Commercially marketed, hydrogel contact lens

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 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	No