On-Eye Evaluation of Contact Lens Rotation Marks

Not Applicable

Completed

• Conditions: Refractive Error
• Interventions: Device: Delefilcon A spherical contact lens with molded marks; Device: Etafilcon A toric contact lens

• Registration Number: NCT02055404
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-02
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Results First Submitted: 2014-02-20
• Results First Submitted QC: 2014-02-20
• Last Update Submitted: 2014-02-20
• Results First Posted: 2014-04-02
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• Sign Informed Consent document.
• Best corrected distance visual acuity (VA) 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 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.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delefilcon A	Delefilcon A spherical contact lens with molded marks	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
Etafilcon A	Etafilcon A toric contact lens	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

Primary Outcome Measures

Name	Time	Method
Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)	Day 1	Each lens (containing 8 rotation marks and one reference mark, in total 9 marks) was assessed for visibility by 10 investigators using the following scale: "N/A;" "Not visible;" "Slightly visible, not acceptable;" "Slightly visible, acceptable;" "Clearly visible;" "More visible than necessary." Visibility assessments were made after all marks had been evaluated. S9 Mark (test lens) functioned as a starting marker only and was not rated. The control lens was not used as a comparison, but rather as a reference for what a mark looks like on a commercial product. "Visibility of Rotation Mark" is reported as the percentage of assessments rating the rotation mark as "Clearly visible" or "Slightly visible, acceptable."