Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses
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ClinicalTrials.gov Identifier: NCT01629693 |
Recruitment Status
:
Completed
First Posted
: June 28, 2012
Results First Posted
: November 6, 2014
Last Update Posted
: November 6, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myopia Astigmatism | Device: Lotrafilcon B contact lenses Device: Comfilcon A contact lenses | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 398 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Official Title: | Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses |
Study Start Date : | July 2013 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Air Optix
Lotrafilcon B contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection).
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Device: Lotrafilcon B contact lenses
Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription
Other Names:
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Active Comparator: Biofinity
Comfilcon A contact lenses worn bilaterally (in both eyes) for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis (removed nightly for cleaning and disinfection).
|
Device: Comfilcon A contact lenses
Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription
Other Names:
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- Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30 [ Time Frame: Baseline, 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629693
Study Director: | Jami Kern, Ph.D. | Alcon Research |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT01629693 History of Changes |
Other Study ID Numbers: |
A00973 |
First Posted: | June 28, 2012 Key Record Dates |
Results First Posted: | November 6, 2014 |
Last Update Posted: | November 6, 2014 |
Last Verified: | October 2014 |
Keywords provided by Alcon Research:
contact lenses myopia astigmatism |
Additional relevant MeSH terms:
Myopia Astigmatism Refractive Errors Eye Diseases |