AIR OPTIX® COLORS Registration Trial

Refractive Error Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440322
• Other study ID #: P-383-C-003 (C-11-032)
• Status: Completed
• Phase: N/A
• First received: September 22, 2011
• Last updated: April 24, 2014
• Start date: September 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2014
• 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 evaluate the subjective and objective performance and the physiological response to AIR OPTIX® COLORS soft contact lenses compared with AIR OPTIX® AQUA contact lenses in participants with normal eyes and prescription needs.

Description:

This study consisted of 7 scheduled visits conducted over a 3-month period. Enrolled participants were randomized (2:1) to receive either AIR OPTIX® COLORS lenses in both eyes or AIR OPTIX® AQUA lenses in both eyes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Be of legal age of consent and sign Informed Consent document. If under legal age of consent, legally authorized representative must sign Informed Consent document and subject must sign Assent document.

• Normal eyes and not using any ocular medications.

• Willing to wear visitint or gray-colored spherical contact lenses in both eyes within available power ranges.

• Manifest cylinder less than or equal to 0.75 diopter.

• Best spectacle corrected visual acuity greater than or equal to 20/25.

• Have current prescription glasses.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Anterior segment infection, inflammation, or abnormality.

• Any active anterior segment ocular or systemic disease that would contraindicate contact lens wear.

• Use of ocular or systemic medications for which contact lens wear could be contraindicated as determined by the investigator.

• History of refractive surgery or irregular cornea.

• History of pathologically dry eye.

• Corneal vascularization greater than 1 millimeter of penetration.

• History of herpetic keratitis.

• Eye injury within 12 weeks immediately prior to enrollment in this trial.

• Currently enrolled in any clinical trial or participation in any clinical trial within the previous 30 days.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Lotrafilcon B contact lens with color
Silicone hydrogel contact lens with color
• Lotrafilcon B contact lens
Silicone hydrogel contact lens

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 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 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 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 Fit (Optimal, Acceptably Loose, Acceptably Tight)	Lens fit, as assessed by the investigator for each eye individually. Lens fit was rated on a 5-point scale: 2=unacceptably loose, 1=acceptably loose, 0=optimal, -1=acceptably tight, -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	Lens Centration (Centered, Slight Decentration)	Lens centration, as assessed by the investigator for each eye individually. Lens centration was rated 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	Dry Areas/Non-Wetting (None, Very Slight)	Dry areas/non-wetting (i.e., assessment of the disruption of the front surface wettability of the contact lens), as assessed by the investigator for each eye individually. Dry areas/non-wetting was rated 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 rated 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 Deposits (None, Very Slight)	Back surface deposits on the contact lens, as assessed by the investigator for each eye individually. Back surface deposits were rated 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