N/A
N=22
Daytime Corneal Swelling During Wear of Narafilcon B Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01444287 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Corneal Thickness — -0.35; -0.99; 0.75; -1.02 Percent Change — p=0.0035
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- narafilcon B (Device); Polymacon (Device); Lotrafilcon A (Device); Spectacles (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Thickness |
-0.35; -0.99; 0.75; -1.02 | 0.0035 sig |
| PRIMARY Endothelial Blebs |
-0.13; 0.49; 0.41; 0.38 | 0.0692 |
| PRIMARY Limbal Redness |
-0.03; -0.04; 0.64; 0.13 | 0.9127 |
| SECONDARY Overall Comfort |
96.0; 96.1; 78.3; 80.7 | 0.9892 |
Summary
The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.
Eligibility Criteria
Inclusion Criteria
- Be of legal age (i.e. ≥ 18 years).
- Be mentally competent, willing and able to sign a written informed consent form.
- Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
- Have spectacle astigmatism <1.25D in each eye.
- Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
- Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.
Exclusion Criteria
- Required concurrent ocular medication.
- Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- Eye injury or surgery within eight 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.
- Pregnancy, lactating or planning a pregnancy at the time of enrollment.
- Participation in any concurrent clinical trial.
Data sourced from ClinicalTrials.gov (NCT01444287). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.