On-Eye Evaluation of Contact Lens Axis Location

NCT ID: NCT02100410

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-04-30

Brief Summary

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.

Conditions

Myopia; Astigmatism; Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

Iteration 2-87-1

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

Group Type: EXPERIMENTAL

Delefilcon A toric contact lens T1

Intervention Type: DEVICE

Iteration 2-87-1 with embossed mark

Delefilcon A toric contact lens T2

Intervention Type: DEVICE

Iteration 2-87-1 without embossed mark

Iteration 2-87-2

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

Group Type: EXPERIMENTAL

Delefilcon A toric contact lens T3

Intervention Type: DEVICE

Iteration 2-87-2 with embossed mark

Delefilcon A toric contact lens T4

Intervention Type: DEVICE

Iteration 2-87-2 without embossed mark

Iteration 2-87-3

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

Group Type: EXPERIMENTAL

Delefilcon A toric contact lens T5

Intervention Type: DEVICE

Iteration 2-87-3 with embossed mark

Delefilcon A toric contact lens T6

Intervention Type: DEVICE

Iteration 2-87-3 without embossed mark

Interventions

Delefilcon A toric contact lens T1

Iteration 2-87-1 with embossed mark

Intervention Type: DEVICE

Delefilcon A toric contact lens T2

Iteration 2-87-1 without embossed mark

Intervention Type: DEVICE

Delefilcon A toric contact lens T3

Iteration 2-87-2 with embossed mark

Intervention Type: DEVICE

Delefilcon A toric contact lens T4

Iteration 2-87-2 without embossed mark

Intervention Type: DEVICE

Delefilcon A toric contact lens T5

Iteration 2-87-3 with embossed mark

Intervention Type: DEVICE

Delefilcon A toric contact lens T6

Iteration 2-87-3 without embossed mark

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Sign written Informed Consent.
• Best corrected distance visual acuity greater than or equal to 20/25 in each eye.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joachim Nick, Dipl. Ing.

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-12-061

Identifier Type: -

Identifier Source: org_study_id