Clinical Evaluation of an Investigational Soft Contact Lens

Ciba Vision

Status: Completed

Conditions: Myopia

Treatments: Device: Delefilcon A contact lens; Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX); Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE); Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254747

P-347-C-003v2s2v2

Details and patient eligibility

About

The purpose of this 4-week dispensing trial is to evaluate and compare an investigational soft contact lens worn on a daily disposable basis with three other soft contact lenses also worn on a daily disposable basis.

Enrollment: 130 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Germany: Be of legal age.
• USA: Be of legal age or, if under legal age, have written consent of parent/guardian to participate and sign informed assent.
• Sign Informed Consent.
• Wear soft contact lenses for at least 3 months prior to the study.
• Wear soft contact lenses on a daily disposable basis, daily wear basis, or occasional extended wear basis.
• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks prior to enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Regularly wear contact lenses on an extended/overnight basis.
• Germany: pregnant or lactating.
• Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 4 patient groups

Delefilcon A

Experimental group

Description:

Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Treatment:

Device: Delefilcon A contact lens

Lotrafilcon B

Active Comparator group

Description:

Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Treatment:

Device: Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)

Nelfilcon A

Active Comparator group

Description:

Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Treatment:

Device: Nelfilcon A contact lens (DAILIES AquaComfort Plus)

Narafilcon A

Active Comparator group

Description:

Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.

Treatment:

Device: Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)