Subjective Evaluation of a Commercially Marketed Contact Lens Amongst a Subset of the Contact Lens Wearing Population

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007916
• Other study ID #: P-336-C-016
• Status: Completed
• Phase: N/A
• First received: November 2, 2009
• Last updated: June 26, 2012
• Start date: October 2009
• Est. completion date: January 2010

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 study is to compare the performance of commercially marketed contact lenses to habitual contact lenses in a selected segment of the contact lens wearing population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Habitual spherical soft contact lens wearer who wears a contact lens with a recommended replacement schedule of 2 weeks or monthly.

• Wears lenses at least 5 days per week and at least 12 hours per day.

• Removes contact lenses daily or, if prescribed by their regular eye care practitioner, sleeps overnight in contact lenses no more than 6 consecutive nights.

• Reports 2 or fewer common lens-related symptoms with current contact lenses with a frequency of "frequently" or "always".

• Able to achieve distance visual acuity of at least 20/40 in each eye at the dispense of each pair of study lenses.

• Has acceptable or optimal fit for each eye at the dispense of each pair of study lenses.

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

Exclusion Criteria:

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

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

• Currently enrolled in any clinical trial.

• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.

• Currently sleeping in contact lenses for more than 6 consecutive nights.

• Currently wearing daily disposable contact lenses and certain protocol-specified lens brands.

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

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of monthly.
• Habitual contact lens
Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort Upon Insertion	Comfort upon insertion, as interpreted by the participant, was recorded on a questionnaire by the participant using a 10-point scale, with 1 being poor and 10 being excellent. Comfort upon insertion was assessed as a single, retrospective evaluation of 4-weeks' wear time.	4 weeks of wear	No