Prospective Study of an Investigational Toric Soft Contact Lens

ARES Registration Trial

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Astigmatism; Myopia
• Intervention / Treatment: Device: Nelfilcon A toric contact lenses; Device: Nelfilcon A toric contact lenses (with comfort additives)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DAILIES® AquaComfort Plus® Toric; 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)
ACTIVE_COMPARATOR: Focus® DAILIES® Toric; 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; Other Names: Focus® DAILIES® Toric

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CIBA VISION
• Investigators: Study Director: Mary Fahmy, OD, Alcon Research

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: October 26, 2011
• First Submitted That Met QC Criteria: October 27, 2011
• First Posted (ESTIMATE): October 28, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 17, 2013
• Last Update Submitted That Met QC Criteria: August 9, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: astigmatism; contact lenses; soft contact lenses; toric; daily disposable contact lenses; contact lens comfort
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: C-11-035 (P-415-C-003)