Clinical Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement Lens
This study has been completed.
Sponsor:
Vistakon
Collaborator:
Visioncare Research Ltd.
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01151371
First received: March 24, 2010
Last updated: November 14, 2011
Last verified: November 2011
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Purpose
The objective of the study is to compare the clinical performance of silicone hydrogel daily disposable contact lenses, conventional hydrogel daily disposable contact lenses and silicone hydrogel monthly replacement contact lenses.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: narafilcon B contact lens Device: nelfilcon A contact lens Device: lotrafilcon B contact lens |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Vistakon:
Primary Outcome Measures:
- Overall Comfort Narafilcon B v. Nelfilcon A [ Time Frame: After 1 week ] [ Designated as safety issue: No ]Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
- Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]Redness scale of 0 to 4, where 0=None, 4=Severe redness
- Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
- Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]Redness scale of 0 to 4, where 0=None, and 4=Severe.
Secondary Outcome Measures:
- Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]Standard scale of 0 to 3 where 0=None, 3=Severe staining
- Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
- Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort
- Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A [ Time Frame: After 1 Week ] [ Designated as safety issue: No ]Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort.
- Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]Scale of 0 to 3, where 0=none and 3=severe staining.
- Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
- Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort
- Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B [ Time Frame: After 4 Weeks ] [ Designated as safety issue: No ]Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort.
| Enrollment: | 452 |
| Study Start Date: | February 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: narafilcon B daily disposable 4 weeks
narafilcon B soft contact lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
|
Device: narafilcon B contact lens
Silicone Hydrogel Daily Disposable Contact Lenses
|
|
Active Comparator: nelfilcon A daily disponsable 1 week
nelfilcon A soft contact lenses worn daily on a daily disposable/replacement schedule, for 1 week
|
Device: nelfilcon A contact lens
Conventional Hydrogel Daily Disposable Contact Lenses
|
|
Active Comparator: lotrafilcon B daily wear, monthly replacement, 4-weeks
lotrafilcon B soft contact lenses worn daily on a 1-month replacement schedule, for 4 weeks
|
Device: lotrafilcon B contact lens
Silicone Hydrogel Monthly Replacement Contact Lenses
|
Eligibility| Ages Eligible for Study: | 18 Years to 39 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Be no less than 18 and no more than 39 years of age.
- Sign Written Informed Consent and investigator to record this on Case Report Form (See separate document).
- Be willing and able to adhere to the instructions set out in the protocol.
- Own a cell phone and be willing to receive text messages during the day.
- Be an existing successful daily wear soft contact lens. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
- No extended wear in the last 3 months.
- Subjective refraction must result in a vertexed spherical contact lens prescription between -1.00 and -6.00D.
- Have refractive astigmatism less than or equal to 1.00D in both eyes.
- Achieve visual acuity of 6/9 (20/30) or better in each eye.
- Require a visual correction in both eyes (no monofit or monovision allowed).
- Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
- Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- No amblyopia.
No evidence of lid abnormality or infection (including blepharitis/meibomitis).
- No conjunctival abnormality or infection.
- No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities).
- No other active ocular disease.
Exclusion Criteria:
- Requires concurrent ocular medication.
- Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Clinically significant corneal staining (Grade 3 in more than one corneal region per eye).
- Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
- Has had refractive surgery.
- Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
- Abnormal lacrimal secretions.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Keratoconus or other corneal irregularity.
- PMMA(polymethyl methacrylate), hybrid or RGP(rigid gas permeable) lens wear in the previous 8 weeks.
Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Diabetic.
- Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV (Human immunodeficiency virus)).
- History of chronic eye disease (e.g. glaucoma or ARMD (age related macular degeneration)).
- Pregnancy, lactating or planning a pregnancy at the time of enrolment.
- Participation in any concurrent clinical trial or in last 30 days.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01151371
Hide Study Locations
Hide Study LocationsLocations
| United States, California | |
| Brea, California, United States | |
| Canoga Park, California, United States | |
| Corona, California, United States | |
| United States, Connecticut | |
| Bridgeport, Connecticut, United States | |
| United States, Florida | |
| Jacksonville, Florida, United States, 32256 | |
| Jacksonville, Florida, United States, 32205 | |
| Tampa, Florida, United States | |
| Winter Park, Florida, United States | |
| United States, Georgia | |
| Roswell, Georgia, United States | |
| United States, Indiana | |
| Mishawaka, Indiana, United States | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States | |
| United States, Missouri | |
| Blue Springs, Missouri, United States | |
| Independence, Missouri, United States | |
| Lake Ozark, Missouri, United States | |
| United States, New York | |
| New York, New York, United States | |
| United States, North Carolina | |
| Raleigh, North Carolina, United States | |
| United States, Ohio | |
| Chagrin Falls, Ohio, United States | |
| North Olmsted, Ohio, United States | |
| Warren, Ohio, United States | |
| United States, Pennsylvania | |
| Kittanning, Pennsylvania, United States | |
| State College, Pennsylvania, United States | |
| United States, Rhode Island | |
| Warwick, Rhode Island, United States | |
| United States, Tennessee | |
| Bartlett, Tennessee, United States | |
| Brentwood, Tennessee, United States | |
| United States, Texas | |
| Tyler, Texas, United States, 75701 | |
| Tyler, Texas, United States, 75703 | |
| United States, Vermont | |
| Burlington, Vermont, United States | |
| United States, Virginia | |
| Virginia Beach, Virginia, United States | |
Sponsors and Collaborators
Vistakon
Visioncare Research Ltd.
More Information
No publications provided
| Responsible Party: | Vistakon |
| ClinicalTrials.gov Identifier: | NCT01151371 History of Changes |
| Other Study ID Numbers: | CR-0917 |
| Study First Received: | March 24, 2010 |
| Results First Received: | September 15, 2011 |
| Last Updated: | November 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013