Prospective Study of an Investigational Toric Soft Contact Lens

Study Overview
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Brief Summary
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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.

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

Official Title
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ARES Registration Trial

Conditions
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Myopia, Astigmatism, Refractive Error

Intervention / Treatment
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* Device: Nelfilcon A toric contact lenses (with comfort additives)
* Device: Nelfilcon A toric contact lenses


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAILIES® AquaComfort Plus® Toric<br>Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months | Device: Nelfilcon A toric contact lenses (with comfort additives)<br> <br> |
| Active Comparator: Focus® DAILIES® Toric<br>Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months | Device: Nelfilcon A toric contact lenses<br> <br> * Other names: Focus® DAILIES® Toric;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contact Lens-Corrected Distance Monocular Snellen Visual Acuity (VA) (20/30 or Better) | 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. | Up to Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Rating of Insertion Comfort | 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. | Up to Month 3 | 
| Subjective Rating of End of Day Comfort | 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. | Up to Month 3 | 
| Subjective Rating of Overall Comfort | 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. | Up to Month 3 | 
| Subjective Rating of End of Day Dryness | 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. | Up to Month 3 | 
| Subjective Rating of Overall Vision | 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. | Up to Month 3 | 
| Subjective Rating of Overall Handling | 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. | Up to Month 3 | 
| Lens Centration (Centered, Slight Decentration) | 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. | Up to Month 3 | 
| Lens Fit (Optimal, Acceptably Loose, Acceptably Tight) | 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. | Up to Month 3 | 
| Front Surface Wettability (None, Very Slight) | 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. | Up to Month 3 | 
| Front Surface Deposits (None, Very Slight) | 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. | Up to Month 3 | 
| Back Surface Debris/Deposits (None, Very Slight) | 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. | Up to Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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toric, contact lenses, daily disposable contact lenses, astigmatism, soft contact lenses, contact lens comfort