On-Eye Evaluation of Contact Lens Rotation Marks

February 20, 2014 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: 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.
Other: 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
Device: Etafilcon A toric contact lens
Hydrogel toric contact lens for daily wear, daily disposable use
Other Names:
  • 1-DAY ACUVUE® MOIST® for ASTIGMATISM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Joachim Nick, Dipl. Ing., Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 5, 2014

Study Record Updates

Last Update Posted (Estimate)

April 2, 2014

Last Update Submitted That Met QC Criteria

February 20, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-12-045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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