Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

Myopia Clinical Trial

Official title:

Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Daily Disposable Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035905
• Other study ID #: P-337-C-030
• Status: Completed
• Phase: N/A
• First received: December 18, 2009
• Last updated: June 26, 2012
• Start date: September 2009
• Est. completion date: December 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 study is to evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of two different daily disposable contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Currently wear daily disposable, spherical, soft lens wearers (except the two study products) for at least the past 6 months.

• Habitually wear lenses for at least 8 hours per day and 4 days per week.

• Report 2 or more qualifying symptoms with current contact lenses.

• Able to achieve visual acuity of at least 20/40 in each eye with habitual and with study lenses at dispense.

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

Exclusion Criteria:

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

• Currently enrolled in any clinical trial.

• Any use of ocular medications, exclusive of contact lens rewetting drops.

• History of corneal or refractive surgery.

• Cylinder correction greater than 1.00 D

• Current monovision contact lens wearers.

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Nelfilcon A contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
• Narafilcon A contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Awareness	Lens awareness, as interpreted by the subject and reported by the subject in a questionnaire as a single, retrospective evaluation of 4-week's wear time. Frequency of lens awareness was measured on a 4-point scale, with 1 being never and 4 being always. Four-week ratings were compared to baseline ratings, and a negative difference (4 week minus baseline) represented an improvement.	4 weeks of wear	No