Prospective Study of an Investigational Toric Soft Contact Lens

• ClinicalTrials.gov Identifier: NCT01461811
• Recruitment Status: Completed
• First Posted: October 28, 2011
• Results First Posted: October 17, 2013
• Last Update Posted: October 17, 2013
• Sponsor: CIBA VISION
• Information provided by (Responsible Party): Alcon Research ( CIBA VISION )

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Myopia; Astigmatism; Refractive Error	Device: Nelfilcon A toric contact lenses (with comfort additives); Device: Nelfilcon A toric contact lenses	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: ARES Registration Trial
• Study Start Date: December 2011
• Actual Primary Completion Date: April 2012
• Actual Study Completion Date: April 2012

Arms and Interventions

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 Name: Focus® DAILIES® Toric

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

CIBA VISION

Investigators

• Study Director: Mary Fahmy, OD; Alcon Research

More Information

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01461811
• Other Study ID Numbers: C-11-035 (P-415-C-003)
• First Posted: October 28, 2011
• Results First Posted: October 17, 2013
• Last Update Posted: October 17, 2013
• Last Verified: August 2013

Keywords provided by Alcon Research ( CIBA VISION ):

toric; contact lenses; daily disposable contact lenses; astigmatism; soft contact lenses; contact lens comfort

Additional relevant MeSH terms:

Astigmatism; Refractive Errors; Eye Diseases