On-Eye Evaluation of Contact Lens Rotation Marks

NCT ID: NCT02055404

Last Updated: 2014-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-02-28

Brief Summary

The purpose of this study was to select the size of the molded rotation mark for a new toric contact lens by comparing the visibility of various molded rotation marks.

Detailed Description

Participants wore the test and control products contralaterally (in each eye separately) for 2 hours, during which the Investigator assessed the various molded rotation marks for visibility. Each participant was assessed by 10 investigators.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Delefilcon A

Delefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration

Group Type: EXPERIMENTAL

Delefilcon A spherical contact lens with molded marks

Intervention Type: DEVICE

Silicone hydrogel contact lens with 9 different molded marks of varying widths and depths indented into the front surface (S1, S2, S3, S4, S5, S6, S7, S8, and S9). Each lens contained all 9 marks.

Etafilcon A

Etafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration

Group Type: OTHER

Etafilcon A toric contact lens

Intervention Type: DEVICE

Hydrogel toric contact lens for daily wear, daily disposable use

Interventions

Delefilcon A spherical contact lens with molded marks

Silicone hydrogel contact lens with 9 different molded marks of varying widths and depths indented into the front surface (S1, S2, S3, S4, S5, S6, S7, S8, and S9). Each lens contained all 9 marks.

Intervention Type: DEVICE

Etafilcon A toric contact lens

Hydrogel toric contact lens for daily wear, daily disposable use

Intervention Type: DEVICE

Other Intervention Names

1-DAY ACUVUE® MOIST® for ASTIGMATISM

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• History of any ocular surgery or ocular injury within 12 weeks of study enrollment.
• Any ocular disease, infection, inflammation, or abnormality that contraindicates contact lens (CL) wear.
• History of herpetic keratitis.
• Slit-lamp findings greater than grade 2 at baseline.
• Any use of systemic or ocular medications for which CL wear could be contraindicated.
• Inactive corneal neovascularization greater than 1 millimeter of penetration.
• A clinically significant dry eye not responding to treatment.
• History of refractive surgery.
• Participation in a clinical study within the previous 30 days.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

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-12-045

Identifier Type: -

Identifier Source: org_study_id