Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01634659
• Other study ID #: M-12-033
• Status: Completed
• Phase: N/A
• First received: July 3, 2012
• Last updated: November 27, 2013
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: November 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 compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sign written Informed Consent Document and HIPAA form.

• Be current weekly/monthly replacement contact lens wearer.

• Be willing to not sleep in contact lenses during the study period.

• Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.

• Have best corrected visual acuity of at least 20/25 in each eye.

• Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.

• Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Be a neophyte or current wearer of daily disposable lenses.

• Require monovision correction or use multifocal contact lenses.

• Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.

• Have a history of ocular surgery/trauma within the last 6 months.

• Use topical ocular or systemic antibiotics within 7 days of enrollment.

• Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.

• Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.

• Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.

• Use re-wetting drops once or more per day.

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Delefilcon A contact lenses (DAILIES TOTAL1®)
Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use
• Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)
Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Comfort	Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.	Day 8	No
Secondary	Overall Quality of Vision	Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.	Day 8	No
Secondary	End of Day Comfort	End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.	Day 8	No