Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US

Ciba Vision

Status: Completed

Conditions: Astigmatism

Treatments: Device: Comfilcon A contact lens; Device: Lotrafilcon B contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01007812

P-242-C-032

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Lotrafilcon B / Comfilcon A

Other group

Description:

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.

Treatment:

Device: Lotrafilcon B contact lens

Device: Comfilcon A contact lens

Comfilcon A / Lotrafilcon B

Other group

Description:

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.

Treatment:

Device: Lotrafilcon B contact lens

Device: Comfilcon A contact lens