Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629693
• Other study ID #: A00973
• Status: Completed
• Phase: N/A
• First received: June 26, 2012
• Last updated: November 3, 2014
• Start date: July 2013
• Est. completion date: November 2013

Study information

• Verified date: October 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 is to evaluate differences in the comfort at the end of the month between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft contact lens wearers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 398
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must sign written informed consent document.

• Currently wearing weekly/biweekly or monthly sphere or toric soft contact lenses (NOT including AIR OPTIX Aqua, AIR OPTIX NIGHT & DAY Aqua, AIR OPTIX for Astigmatism, Biofinity Sphere, Biofinity Toric, or ProClear Toric soft contact lenses) bilaterrally (in both eyes) and have worn these lenses for at least 3 months, daily wear use only (no extended wear).

• Symptomatic for contact lens-related ocular discomfort at the end of the lens wearing day.

• Current contact lens prescription within the available parameters of both study products.

• Able to achieve visual acuity (VA) of at least 6/7.5 (20/25) in each eye with study lenses in the available parameters.

• Willing to wear study lenses for at least 4 hours/day and at least 5 days/week for the 1 month trial period.

• Willing and able to follow instructions, study procedures and maintain the appointment schedule.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Neophytes and current wearers of AIR OPTIX Aqua, AIR OPTIX NIGHT & DAY Aqua, AIR OPTIX for Astigmatism, Biofinity sphere, Biofinity Toric, or ProClear Toric soft contact lenses.

• Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.

• Recent (within 7 days of enrollment) or current ocular infections, active ocular inflammation, glaucoma or preauricular lymphadenopathy.

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

• Topical or systemic antibiotics use within 7 days of enrollment.

• Topical ocular or systemic corticosteroids use within 14 days of enrollment.

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

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Astigmatism
• Myopia

Intervention

Device:
• Lotrafilcon B contact lenses
Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription
• Comfilcon A contact lenses
Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30	Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.	Baseline, Day 30	No