Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

Myopia Clinical Trial

Official title:

Evaluation of Two Silicone Hydrogel Lenses Over a One Month Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810511
• Other study ID #: P-335-C-007
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: January 2009

Study information

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

Clinical Trial Summary

The purpose of this trial is to compare two different contact lenses during 4 weeks of wear.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Current soft contact lens wearer who wear their habitual lenses for no less than 10 hours a day, 5 days a week

• Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye while wearing trial lenses

• Replace lenses on a weekly or longer schedule

• Other protocol inclusion/exclusion criteria may apply

Exclusion Criteria:

• Requires concurrent ocular medication

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

• Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions

• Current soft toric lens wearers

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

• Current NIGHT & DAY® or Biofinity® lens wearers

• Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon A contact lens
Silicone hydrogel contact lens
• Comfilcon A contact lens
Silicone hydrogel 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 at End of Day	Evaluated by the subject as a single, retrospective evaluation of 4-week wear time. Measured on a 10-point scale, with 1 being poor and 10 being excellent.	After 4 weeks of wear