On-Eye Evaluation of Contact Lens Rotation Marks

Study Overview
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Brief Summary
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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
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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
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Refractive Error

Intervention / Treatment
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* Device: Delefilcon A spherical contact lens with molded marks
* Device: Etafilcon A toric contact lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Delefilcon A<br>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<br>* 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.<br>|
| Other: Etafilcon A<br>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<br>* Hydrogel toric contact lens for daily wear, daily disposable use<br>* Other names: 1-DAY ACUVUE® MOIST® for ASTIGMATISM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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astigmatism, toric, contact lenses, daily disposable contact lenses, molded mark, rotation mark