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On-Eye Evaluation of Contact Lens Rotation Marks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055404
Recruitment Status : Completed
First Posted : February 5, 2014
Results First Posted : April 2, 2014
Last Update Posted : April 2, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Refractive Error Device: Delefilcon A spherical contact lens with molded marks Device: Etafilcon A toric contact lens Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : February 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


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.

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 Name: 1-DAY ACUVUE® MOIST® for ASTIGMATISM




Primary Outcome Measures :
  1. 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."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055404


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Joachim Nick, Dipl. Ing. Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02055404    
Other Study ID Numbers: C-12-045
First Posted: February 5, 2014    Key Record Dates
Results First Posted: April 2, 2014
Last Update Posted: April 2, 2014
Last Verified: February 2014
Keywords provided by Alcon Research:
astigmatism
toric
contact lenses
daily disposable contact lenses
molded mark
rotation mark
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases