Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

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

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Lotrafilcon B contact lens; Device: Comfilcon A contact lens

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lotrafilcon B / Comfilcon A; 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.	Device: Lotrafilcon B contact lens; Silicone hydrogel, toric, soft contact lens; Device: Comfilcon A contact lens; Silicone hydrogel, toric, soft contact lens
Other: Comfilcon A / Lotrafilcon B; 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.	Device: Lotrafilcon B contact lens; Silicone hydrogel, toric, soft contact lens; Device: Comfilcon A contact lens; Silicone hydrogel, toric, soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Vision	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.	After 1 week of wear

Collaborators and Investigators

• Sponsor: CIBA VISION

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: November 2, 2009
• First Submitted That Met QC Criteria: November 3, 2009
• First Posted (Estimate): November 4, 2009

Study Record Updates

• Last Update Posted (Estimate): June 29, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: P-242-C-032