On-Eye Evaluation of Contact Lens Axis Location

Alcon

Status: Completed

Conditions: Myopia; Refractive Error; Astigmatism

Treatments: Device: Delefilcon A toric contact lens T2; Device: Delefilcon A toric contact lens T6; Device: Delefilcon A toric contact lens T4; Device: Delefilcon A toric contact lens T1; Device: Delefilcon A toric contact lens T5; Device: Delefilcon A toric contact lens T3

Study type: Interventional

Funder types: Industry

Identifiers

NCT02100410

C-12-061

Details and patient eligibility

About

The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens without embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign written Informed Consent.
• Best corrected distance visual acuity greater than or equal to 20/25 in each eye.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• History of any ocular surgery or ocular injury within 12 weeks of enrollment for this study.
• Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear.
• History of herpetic keratitis.
• Slit-lamp findings at baseline as specified in the protocol.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during contact lens wear.
• Clinically significant dry eye not responding to treatment.
• History of refractive surgery.
• Other protocol-defined exclusion criteria may apply.

Trial design

50 participants in 3 patient groups

Iteration 2-87-1

Experimental group

Description:

Delefilcon A toric contact lenses T1 and T2 worn contralaterally (1 in each eye) for approximately 30 minutes

Treatment:

Device: Delefilcon A toric contact lens T2

Device: Delefilcon A toric contact lens T1

Iteration 2-87-2

Experimental group

Description:

Delefilcon A toric contact lenses T3 and T4 worn contralaterally (1 in each eye) for approximately 30 minutes

Treatment:

Device: Delefilcon A toric contact lens T4

Device: Delefilcon A toric contact lens T3

Iteration 2-87-3

Experimental group

Description:

Delefilcon A toric contact lenses T5 and T6 worn contralaterally (1 in each eye) for approximately 30 minutes

Treatment:

Device: Delefilcon A toric contact lens T6

Device: Delefilcon A toric contact lens T5