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OpenTrials
Completed

NCT Number: NCT01461811

Prospective Study of an Investigational Toric Soft Contact Lens

The purpose of this study was to demonstrate substantial equivalence of an investigational toric soft contact lens to the commercially available Focus® DAILIES® Toric soft contact lens when worn in a daily wear, daily disposable mode for three months.

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Key information

Conditions

Myopia Astigmatism Eye Diseases Refractive Error Refractive Errors

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Eligible participants were randomized 2:1 to wear either DAILIES® AquaComfort Plus® Toric or Focus® DAILIES® Toric.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and participant must sign Assent document.
  • Normal eyes not using any ocular medications that would contraindicate lens wear.
  • Willing and able to wear toric contact lenses in both eyes within the available range of powers for this trial.
  • Spectacle cylinder prescription between 0.50 and 2.00 diopters.
  • Best spectacle corrected visual acuity 20/25 (Snellen) or better in each eye at distance.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Anterior segment infection, inflammation, or abnormality.
  • Any active anterior segment or systemic disease that would contraindicate contact lens wear.
  • Use of systemic medications that would contraindicate lens wear.
  • Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study.
  • History of herpetic keratitis.
  • History of refractive surgery or irregular cornea.
  • History of pathologically dry eye.
  • Corneal vascularization greater than 1 mm of penetration.
  • Eye injury within twelve weeks immediately prior to enrollment in this trial.
  • Participation in a contact lens or contact lens care product clinical trial within the previous 30 days, or concurrent participation in any clinical trial.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Nelfilcon A toric contact lenses (with comfort additives)

Device

Nelfilcon A toric contact lenses

Device

Other names: Focus® DAILIES® Toric

Primary outcomes

  1. Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better)

    Time frame: Up to Month 3

    Visual acuity, as assessed for each eye individually. Participant read a distance Snellen chart while wearing study lenses. The percentage of eyes with VA recorded as 20/30 or better is reported. Both eyes contributed to the percentage.

Secondary outcomes

  1. Subjective Rating of Insertion Comfort

    Time frame: Up to Month 3

    Insertion comfort (30 seconds to 1 minute), as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.

  2. Subjective Rating of End of Day Comfort

    Time frame: Up to Month 3

    End of day comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.

  3. Subjective Rating of Overall Comfort

    Time frame: Up to Month 3

    Overall comfort, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.

  4. Subjective Rating of End of Day Dryness

    Time frame: Up to Month 3

    End of day dryness, as rated by the participant on a 10-point scale, with 1 being dry and 10 being not dry. The participant rated both eyes together by providing one single rating.

  5. Subjective Rating of Overall Vision

    Time frame: Up to Month 3

    Overall vision, as rated by the participant on a 10-point scale, with 1 being poor and 10 being excellent. The participant rated both eyes together by providing one single rating.

  6. Subjective Rating of Overall Handling

    Time frame: Up to Month 3

    Overall handling, as rated by the participant on a 10-point scale, with 1 being difficult and 10 being easy. The participant rated both eyes together by providing one single rating.

  7. Lens Centration (Centered, Slight Decentration)

    Time frame: Up to Month 3

    Lens centration, as assessed by the investigator for each eye individually. Lens centration was graded on a 5-point scale: 0=centered, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.

  8. Lens Fit (Optimal, Acceptably Loose, Acceptably Tight)

    Time frame: Up to Month 3

    Lens fit, as assessed by the investigator for each eye individually. Lens fit was graded on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight. The combined percentage of lenses assessed as "optimal," "acceptably loose," or "acceptably tight" is reported. Lenses from both eyes contributed to the percentage.

  9. Front Surface Wettability (None, Very Slight)

    Time frame: Up to Month 3

    Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Front surface wettability was graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.

  10. Front Surface Deposits (None, Very Slight)

    Time frame: Up to Month 3

    Front surface deposits on the contact lens, as assessed by the investigator for each eye individually. Front surface deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.

  11. Back Surface Debris/Deposits (None, Very Slight)

    Time frame: Up to Month 3

    Back surface debris/deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface debris/deposits were graded on a 5-point scale: 0=none, 1=very slight, 2=slight, 3=moderate, 4=severe. The combined percentage of lenses assessed as "none" or "very slight" is reported. Lenses from both eyes contributed to the percentage.

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Registry information

Official study title

ARES Registration Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 28, 2011
Registry last updated
Oct 17, 2013

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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