One Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

Myopia Clinical Trial

Official title:

One Month Performance Comparison Between 2 Commercially Available Silicone Hydrogel Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300741
• Other study ID #: P-336-C-018
• Status: Completed
• Phase: N/A
• First received: February 18, 2011
• Last updated: June 26, 2012
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: April 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 two commercially marketed contact lenses when worn for up to one month in a daily wear modality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• 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 brand with a recommended replacement schedule of 2 weeks or greater.

• Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.

• Willing and able to wear spherical contact lenses within the available range of powers.

• Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks 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.

• Astigmatism of 1.00D or more.

• Currently wearing contact lenses in a daily disposable modality.

• Currently wearing AIR OPTIX AQUA or ACUVUE ADVANCE Plus contact lenses.

• Currently sleeping overnight in contact lenses on an occasional or extended wear basis.

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon B contact lens (AIR OPTIX® AQUA)
Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
• Galyfilcon A contact lens (ACUVUE® ADVANCE® Plus)
Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
• Contact lens solution (Clear Care®)
Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comfort on Insertion	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.	4 weeks	No
Primary	Comfort During the Day	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.	4 weeks	No
Primary	Comfort at End of Day	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.	4 weeks	No
Primary	Overall Comfort	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.	4 weeks	No
Primary	Daytime Vision	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.	4 weeks	No
Primary	Low Light Vision	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.	4 weeks	No
Primary	Handling on Insertion	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.	4 weeks	No
Primary	Handling at Removal	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.	4 weeks	No
Primary	Delivers a Healthy, Natural Feeling	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.	4 weeks	No
Primary	Lens Awareness	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.	4 weeks	No
Primary	Overall Satisfaction	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.	4 weeks	No
Primary	Purchase Intent	As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, "How likely would you be to purchase these lenses?" Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses.	4 weeks	No