On-Eye Evaluation of Contact Lens Axis Location

The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens without embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Astigmatism; Myopia
• Intervention / Treatment: Device: Delefilcon A toric contact lens T1; Device: Delefilcon A toric contact lens T2; Device: Delefilcon A toric contact lens T3; Device: Delefilcon A toric contact lens T4; Device: Delefilcon A toric contact lens T5; Device: Delefilcon A toric contact lens T6

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Sign written Informed Consent.
• Best corrected distance visual acuity 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 enrollment for this study.
• Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear.
• History of herpetic keratitis.
• Slit-lamp findings at baseline as specified in the protocol.
• Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during contact lens wear.
• Clinically significant dry eye not responding to treatment.
• History of refractive surgery.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iteration 2-87-1; Delefilcon A toric contact lenses T1 and T2 worn contralaterally (1 in each eye) for approximately 30 minutes	Device: Delefilcon A toric contact lens T1; Iteration 2-87-1 with embossed mark; Device: Delefilcon A toric contact lens T2; Iteration 2-87-1 without embossed mark
Experimental: Iteration 2-87-2; Delefilcon A toric contact lenses T3 and T4 worn contralaterally (1 in each eye) for approximately 30 minutes	Device: Delefilcon A toric contact lens T3; Iteration 2-87-2 with embossed mark; Device: Delefilcon A toric contact lens T4; Iteration 2-87-2 without embossed mark
Experimental: Iteration 2-87-3; Delefilcon A toric contact lenses T5 and T6 worn contralaterally (1 in each eye) for approximately 30 minutes	Device: Delefilcon A toric contact lens T5; Iteration 2-87-3 with embossed mark; Device: Delefilcon A toric contact lens T6; Iteration 2-87-3 without embossed mark

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear	Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Awareness	Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately.	Day 1
Handling on Removal	Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).	Day 1

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Joachim Nick, Dipl. Ing., Alcon Research

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: March 27, 2014
• First Posted (Estimate): April 1, 2014

Study Record Updates

• Last Update Posted (Estimate): May 16, 2014
• Last Update Submitted That Met QC Criteria: April 18, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Toric; Contact Lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: C-12-061