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Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses
This study has been completed.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01629693
First received: June 26, 2012
Last updated: November 3, 2014
Last verified: October 2014
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Purpose
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.
| Condition | Intervention |
|---|---|
| Myopia Astigmatism | Device: Lotrafilcon B contact lenses Device: Comfilcon A contact lenses |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) |
| Official Title: | Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- 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.
| Enrollment: | 398 |
| Study Start Date: | July 2013 |
| Study Completion Date: | November 2013 |
| Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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).
|
Device: Lotrafilcon B contact lenses
Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription
Other Names:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629693
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629693
Sponsors and Collaborators
Alcon Research
Investigators
| Study Director: | Jami Kern, Ph.D. | Alcon Research |
More Information
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01629693 History of Changes |
| Other Study ID Numbers: |
A00973 |
| Study First Received: | June 26, 2012 |
| Results First Received: | November 3, 2014 |
| Last Updated: | November 3, 2014 |
Keywords provided by Alcon Research:
|
contact lenses myopia astigmatism |
Additional relevant MeSH terms:
|
Myopia Astigmatism Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on September 21, 2017