On-Eye Evaluation of Contact Lens Rotation Marks

Refractive Error Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055404
• Other study ID #: C-12-045
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: February 20, 2014
• Start date: February 2013
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

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 toric contact lens
Hydrogel toric contact lens for daily wear, daily disposable use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No