Prospective Study of an Investigational Toric Soft Contact Lens

Myopia Clinical Trial

Official title:

ARES Registration Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461811
• Other study ID #: C-11-035 (P-415-C-003)
• Status: Completed
• Phase: N/A
• First received: October 26, 2011
• Last updated: August 9, 2013
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• Nelfilcon A toric contact lenses (with comfort additives)

• Nelfilcon A toric contact lenses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No