Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

Myopia Clinical Trial

Official title:

Non-dispense Comfort Comparison of Two Silicone Hydrogel Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00808834
• Other study ID #: P-335-C-008
• Status: Completed
• Phase: N/A
• First received: December 11, 2008
• Last updated: June 26, 2012
• Start date: November 2008
• Est. completion date: December 2008

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 subjective responses to two contact lenses after 15 minutes of wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Currently wearing soft contact lenses

• Replaces lenses on a weekly or longer schedule

• Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

• Requires concurrent ocular medication

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

• Currently wearing soft toric lens wearers

• Those who dispose of their soft lenses on a daily basis

• Other protocol-defined inclusion/exclusion criteria may apply

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon A contact lens
Investigational, silicone hydrogel, spherical, soft contact lens
• Senofilcon A contact lens
Commercially marketed, silicone hydrogel, spherical, soft contact lens

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	Evaluated by the subject and measured on a 10-point scale, with 1 being poor and 10 being excellent.	30-60 seconds after initial insertion	No