Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses
This study has been completed.
Sponsor:
Vistakon
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01244516
First received: November 17, 2010
Last updated: December 19, 2011
Last verified: December 2011
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Purpose
The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.
| Condition | Intervention |
|---|---|
|
Myopia |
Device: galyfilcon A, BC 8.30 Device: lotrafilcon B, BC 8.60 Device: comfilcon A, BC 8.60 |
| 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 Subjective Comfort [ Time Frame: after 2 weeks of contact lens wear ] [ 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.
- Corneal Staining [ Time Frame: after 2 weeks of contact lens wear ] [ Designated as safety issue: No ]Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence will be evaluated.
Secondary Outcome Measures:
- Overall Subjective Lens Handling [ Time Frame: after 2 weeks of contact lens wear ] [ 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. Only galyficlon A and comfilcon A were evaluated.
| Enrollment: | 540 |
| Study Start Date: | September 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
galyfilcon A, BC 8.30
galyfilcon A base curve 8.30
|
Device: galyfilcon A, BC 8.30
galyfilcon A, BC 8.30 soft contact lens
|
|
lotrafilcon B, BC 8.60
lotrafilcon B, base curve 8.60
|
Device: lotrafilcon B, BC 8.60
lotrafilcon B, BC 8.60 soft contact lens
|
|
comfilcon A, BC 8.60
comafilcon A, base curve 8.60
|
Device: comfilcon A, BC 8.60
comfilcon A, BC 8.60 soft contact lens
|
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.
- Be willing and able to adhere to the instructions set out in the protocol.
- Be an existing successful daily wear soft contact lens wearer. 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 vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.
- Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.
- Achieve visual acuity of 6/9 (20/30) or better in each eye.
- Require a visual correction in both eyes (no monovision allowed).
- 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 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
- Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
- Has had refractive surgery.
- Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
- Abnormal lacrimal secretions.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Keratoconus or other corneal irregularity.
- Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.
- 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., Human immunodeficiency virus (HIV)].
- History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).
- Pregnancy, lactating or planning a pregnancy at the time of enrollment.
- Participation in any concurrent clinical trial or in last 30 days
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244516
Show 35 Study Locations
Show 35 Study LocationsSponsors and Collaborators
Vistakon
More Information
No publications provided
| Responsible Party: | Vistakon |
| ClinicalTrials.gov Identifier: | NCT01244516 History of Changes |
| Other Study ID Numbers: | CR-201007 |
| Study First Received: | November 17, 2010 |
| Results First Received: | November 29, 2011 |
| Last Updated: | December 19, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Myopia Refractive Errors Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013