On-Eye Evaluation of Contact Lens Rotation Marks

NCT02055404 | Completed Results

• 1 other identifier: C-12-045
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Error

Keywords

astigmatism; toric; contact lenses; daily disposable contact lenses; molded mark; rotation mark

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Delefilcon A

EXPERIMENTAL

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

Etafilcon A

OTHER

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

Interventions

Delefilcon A spherical contact lens with molded marks DEVICE

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.

Delefilcon A

Etafilcon A toric contact lens DEVICE

Hydrogel toric contact lens for daily wear, daily disposable use

Also known as: 1-DAY ACUVUE® MOIST® for ASTIGMATISM

Etafilcon A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign Informed Consent document.
• Best corrected distance visual acuity (VA) greater than or equal to 20/25 in each eye.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Refractive Errors; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Joachim Nick, Dipl. Ing.
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Joachim Nick, Dipl. Ing.

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: February 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 2, 2014
• Results First Posted: April 2, 2014

Record last verified: 2014-02