Assessment of Lotrafilcon A Contact Lenses

Myopia Clinical Trial

Official title:

Assessment of Lotrafilcon A Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185834
• Other study ID #: P-335-C-015
• Status: Completed
• Phase: N/A
• First received: August 18, 2010
• Last updated: June 26, 2012
• Start date: July 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Have normal ocular findings.

• Be able to wear the study lenses in the available powers.

• Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.

• Wear Night & Day contact lenses.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Require concurrent ocular medication.

• Eye injury or surgery within twelve weeks prior to enrollment.

• Currently enrolled in an ophthalmic clinical trial.

• Any active corneal infection.

• Corneal refractive surgery.

• Wear AIR OPTIX NIGHT & DAY AQUA lenses.

• Other protocol-defined exclusion criteria may apply.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon A upgrade soft contact lens
Silicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Comfort	As interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 3 months of wear time. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.	3 months of wear, replacing lenses monthly	No
Secondary	Overall Lens Fit	As assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was graded by eye on a 5-point scale, with 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight	3 months of wear, replacing lenses monthly	No