On-Eye Evaluation of Contact Lens Rotation Marks

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.

Completed

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Key information

Conditions

Refractive Error Astigmatism Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Delefilcon A spherical contact lens with molded marks

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 toric contact lens

Device

Hydrogel toric contact lens for daily wear, daily disposable use

Other names: 1-DAY ACUVUE® MOIST® for ASTIGMATISM

Primary outcomes

Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)

Time frame: 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."

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Feb 5, 2014
Registry last updated: Apr 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed