Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens

• Registration Number: NCT01007812
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Results First Submitted: 2010-09-29
• Results First Submitted QC: 2010-10-21
• Results First Posted: 2010-11-17
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Have a current spectacle prescription, preferably within 6-9 months.
• Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.
• Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.
• Have acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria

• Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
• Currently enrolled in any Clinical Trial.
• Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
• Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
• Currently wearing soft toric contact lenses as extended wear.
• Currently wearing either of the products to be worn in the study.
• Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lotrafilcon B / Comfilcon A	Lotrafilcon B contact lens	Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week.
Lotrafilcon B / Comfilcon A	Comfilcon A contact lens	Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week.
Comfilcon A / Lotrafilcon B	Lotrafilcon B contact lens	Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week.
Comfilcon A / Lotrafilcon B	Comfilcon A contact lens	Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week.

Primary Outcome Measures

Name	Time	Method
Overall Vision	After 1 week of wear	Overall vision, as interpreted by the subject and reported by the subject on a questionnaire as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.