On-Eye Evaluation of Contact Lens Rotation Marks

Alcon

Status: Completed

Conditions: Refractive Error

Treatments: Device: Etafilcon A toric contact lens; Device: Delefilcon A spherical contact lens with molded marks

Study type: Interventional

Funder types: Industry

Identifiers

NCT02055404

C-12-045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

3 participants in 2 patient groups

Delefilcon A

Experimental group

Description:

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

Treatment:

Device: Delefilcon A spherical contact lens with molded marks

Etafilcon A

Other group

Description:

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

Treatment:

Device: Etafilcon A toric contact lens