On-Eye Evaluation of Contact Lens Rotation Marks
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
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.
- 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 herpetic keratitis.
- Other protocol-defined exclusion criteria may apply.
- History of any ocular surgery or ocular injury within 12 weeks of study enrollment.
- ...
- History of herpetic keratitis.
- Other protocol-defined exclusion criteria may apply.
- History of any ocular surgery or ocular injury within 12 weeks of study enrollment.
- Inactive corneal neovascularization greater than 1 millimeter of penetration.
- Any ocular disease, infection, inflammation, or abnormality that contraindicates contact lens (CL) wear.
- A clinically significant dry eye not responding to treatment.
- History of refractive surgery.
- Any use of systemic or ocular medications for which CL wear could be contraindicated.
- Slit-lamp findings greater than grade 2 at baseline.
- Participation in a clinical study within the previous 30 days.
Summary
- Conditions
- Refractive Error
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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.
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.
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.
- 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 herpetic keratitis.
- Other protocol-defined exclusion criteria may apply.
- History of any ocular surgery or ocular injury within 12 weeks of study enrollment.
- ...
- History of herpetic keratitis.
- Other protocol-defined exclusion criteria may apply.
- History of any ocular surgery or ocular injury within 12 weeks of study enrollment.
- Inactive corneal neovascularization greater than 1 millimeter of penetration.
- Any ocular disease, infection, inflammation, or abnormality that contraindicates contact lens (CL) wear.
- A clinically significant dry eye not responding to treatment.
- History of refractive surgery.
- Any use of systemic or ocular medications for which CL wear could be contraindicated.
- Slit-lamp findings greater than grade 2 at baseline.
- Participation in a clinical study within the previous 30 days.
Tracking Information
- NCT #
- NCT02055404
- Collaborators
- Not Provided
- Investigators
- Study Director: Joachim Nick, Dipl. Ing. Alcon Research
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