Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

Myopia Clinical Trial

Official title:

Clinical Evaluation of Two Daily Disposable Lenses in Neophytes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987623
• Other study ID #: P-337-C-031
• Status: Completed
• Phase: N/A
• First received: September 29, 2009
• Last updated: June 26, 2012
• Start date: August 2009
• Est. completion date: December 2009

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 45 Years

Eligibility

Inclusion Criteria:

• No previous contact lens experience or attempts to try contact lenses (neophytes).

• Currently wearing spectacles or needing vision correction in both eyes.

• No older than 45 years of age.

• Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.

• Interested in wearing contact lenses.

• Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.

• 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.

• Previous corneal or refractive surgery.

• Currently enrolled in any Clinical Trial.

• 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
Commercially marketed, hydrogel, single-vision contact lens for daily wear, daily disposable use.
• narafilcon A contact lens
Commercially marketed, silicone hydrogel, single-vision contact lens for daily wear, daily disposable use.

Locations

Country	Name	City	State
United States	The Research Intelligence Group (TRiG)	Fort Washington	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Lens Satisfaction	Overall Lens Satisfaction, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 1-week's wear time. Overall lens satisfaction was measured on a 10-point scale, with 1 being Poor and 10 being Excellent	1 week	No