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Completed

NCT Number: NCT02100410

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.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Error Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Delefilcon A toric contact lens T1

Device

Iteration 2-87-1 with embossed mark

Delefilcon A toric contact lens T2

Device

Iteration 2-87-1 without embossed mark

Delefilcon A toric contact lens T3

Device

Iteration 2-87-2 with embossed mark

Delefilcon A toric contact lens T4

Device

Iteration 2-87-2 without embossed mark

Delefilcon A toric contact lens T5

Device

Iteration 2-87-3 with embossed mark

Delefilcon A toric contact lens T6

Device

Iteration 2-87-3 without embossed mark

Primary outcomes

  1. Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear

    Time frame: Day 1

    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).

Secondary outcomes

  1. Lens Awareness

    Time frame: Day 1

    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.

  2. Handling on Removal

    Time frame: Day 1

    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).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 1, 2014
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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