Prospective Study of an Investigational Toric Soft Contact Lens

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

• Nelfilcon A toric contact lenses (with comfort additives) (Device)
• Nelfilcon A toric contact lenses (Device), also known as Focus® DAILIES® Toric

Primary outcomes

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

• Subjective Rating of Insertion Comfort [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.
• Subjective Rating of End of Day Comfort [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.
• Subjective Rating of Overall Comfort [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.
• Subjective Rating of End of Day Dryness [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.
• Subjective Rating of Overall Vision [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.
• Subjective Rating of Overall Handling [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.
• Lens Centration (Centered, Slight Decentration) [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.
• Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) [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.
• Front Surface Wettability (None, Very Slight) [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.
• Front Surface Deposits (None, Very Slight) [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.
• Back Surface Debris/Deposits (None, Very Slight) [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.

Sex: All

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.

Participant flow

Outcome results

• Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) (Primary), Number, Percentage of eyes: DAILIES® AquaComfort Plus® Toric 98.9; Focus® DAILIES® Toric 98.9
• Subjective Rating of Insertion Comfort (Secondary), Mean, Units on a scale: DAILIES® AquaComfort Plus® Toric 8.9 +/- 1.3; Focus® DAILIES® Toric 9.0 +/- 1.4
• Subjective Rating of End of Day Comfort (Secondary), Mean, Units on a scale: DAILIES® AquaComfort Plus® Toric 7.2 +/- 2.5; Focus® DAILIES® Toric 7.6 +/- 2.1
• Subjective Rating of Overall Comfort (Secondary), Mean, Units on a scale: DAILIES® AquaComfort Plus® Toric 8.1 +/- 1.7; Focus® DAILIES® Toric 8.7 +/- 1.1
• Subjective Rating of End of Day Dryness (Secondary), Mean, Units on a scale: DAILIES® AquaComfort Plus® Toric 7.1 +/- 2.7; Focus® DAILIES® Toric 7.1 +/- 2.3
• Subjective Rating of Overall Vision (Secondary), Mean, Units on a scale: DAILIES® AquaComfort Plus® Toric 8.6 +/- 1.4; Focus® DAILIES® Toric 8.9 +/- 1.2
• Subjective Rating of Overall Handling (Secondary), Mean, Units on a scale: DAILIES® AquaComfort Plus® Toric 9.0 +/- 1.2; Focus® DAILIES® Toric 9.0 +/- 1.7
• Lens Centration (Centered, Slight Decentration) (Secondary), Number, Percentage of lenses: DAILIES® AquaComfort Plus® Toric 97.8; Focus® DAILIES® Toric 98.9
• Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) (Secondary), Number, Percentage of lenses: DAILIES® AquaComfort Plus® Toric 100; Focus® DAILIES® Toric 100
• Front Surface Wettability (None, Very Slight) (Secondary), Number, Percentage of lenses: DAILIES® AquaComfort Plus® Toric 99.4; Focus® DAILIES® Toric 100
• Front Surface Deposits (None, Very Slight) (Secondary), Number, Percentage of lenses: DAILIES® AquaComfort Plus® Toric 100; Focus® DAILIES® Toric 100
• Back Surface Debris/Deposits (None, Very Slight) (Secondary), Number, Percentage of lenses: DAILIES® AquaComfort Plus® Toric 100; Focus® DAILIES® Toric 100

Adverse events

Time frame: Adverse events were collected from the time of consent and reported for the duration of the study.

• Mary Fahmy, OD, Study director, Alcon Research