Comparative Clinical Evaluation of Daily Disposable Lenses in Symptomatic Lens Wearers

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953407
• Other study ID #: P-337-C-027
• Status: Completed
• Phase: N/A
• First received: July 8, 2009
• Last updated: June 26, 2012
• Start date: July 2009
• Est. completion date: September 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 evaluate the extent to which symptoms improve in symptomatic contact lens wearers when fit with one of 5 different daily disposable contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Currently wear spherical, soft contact lenses replaced at intervals of 2 weeks or monthly.

• Habitually wear lenses for at least 8 hours per day, 4 days per week, for at least the past 6 months.

• Report 2 or more qualifying symptoms with current contact lenses with a frequency of "frequently" or "all the time"

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

• Other protocol 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 medications for which contact lens wear could be contraindicated as determined by the investigator.

• History of corneal refractive surgery.

• Cylinder correction greater than 1.00 D.

• Current monovision contact lens wearers.

• Other protocol 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
• Etafilcon A contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
• Omafilcon A contact lens
Daily disposable contact lens worn in a daily wear, daily disposable mode
• Hilafilcon B 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, was reported by the subject 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 all the time. Four-week ratings were compared to baseline ratings, and a negative difference (4-week minus baseline) represented an improvement.	4 weeks of wear	No