Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

Myopia Clinical Trial

Official title:

Assessing the Performance of Lotrafilcon A Lenses During a Three Month Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933166
• Other study ID #: P-335-C-014v2
• Status: Completed
• Phase: N/A
• First received: July 2, 2009
• Last updated: June 26, 2012
• Start date: June 2009
• Est. completion date: November 2009

Study information

• Verified date: January 2012
• 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 trial is to assess the performance of an investigational contact lens over a three month period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• On examination, have ocular findings considered to be "normal," and which would not prevent a participant from safely wearing contact lenses.

• Be willing and able to follow instructions and meet the schedule of follow-up visits as defined in the informed consent.

• 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.

• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks of enrollment.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Currently enrolled in an ophthalmic clinical trial.

• Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.

• History of corneal refractive surgery.

• Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon A contact lens
Investigational silicone hydrogel, single vision, soft contact lens worn on a daily wear basis, flexible wear basis, or extended wear basis for three months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort After Insertion	Comfort after insertion (30 seconds to 1 minute) as interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of three months' wear time. Comfort after insertion was measured on a 10-point scale, with 1 being poor and 10 being excellent.	3 months	No