On-Eye Evaluation of Contact Lens Axis Location

NCT02100410 | Completed Results

• 1 other identifier: C-12-061
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myopia; Astigmatism; Refractive Error

Keywords

Contact Lens; Toric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Lens Awareness

  Day 1

• Handling on Removal

  Day 1

Study Arms (3)

Iteration 2-87-1

EXPERIMENTAL

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; Device: Delefilcon A toric contact lens T2

Iteration 2-87-2

EXPERIMENTAL

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; Device: Delefilcon A toric contact lens T4

Iteration 2-87-3

EXPERIMENTAL

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; Device: Delefilcon A toric contact lens T6

Interventions

Delefilcon A toric contact lens T1 DEVICE

Iteration 2-87-1 with embossed mark

Iteration 2-87-1

Delefilcon A toric contact lens T2 DEVICE

Iteration 2-87-1 without embossed mark

Iteration 2-87-1

Delefilcon A toric contact lens T3 DEVICE

Iteration 2-87-2 with embossed mark

Iteration 2-87-2

Delefilcon A toric contact lens T4 DEVICE

Iteration 2-87-2 without embossed mark

Iteration 2-87-2

Delefilcon A toric contact lens T5 DEVICE

Iteration 2-87-3 with embossed mark

Iteration 2-87-3

Delefilcon A toric contact lens T6 DEVICE

Iteration 2-87-3 without embossed mark

Iteration 2-87-3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign written Informed Consent.
• Best corrected distance visual acuity 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 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Myopia; Astigmatism; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Joachim Nick, Dipl.-Ing. (FH), Clinical Lead
• 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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 1, 2014
• Study Start: April 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 16, 2014
• Results First Posted: May 16, 2014

Record last verified: 2014-04