N/A
N=98
Assessment of Daily Disposable Silicone Hydrogel Lens Wear
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01093625 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Papillary Conjunctivitis — 0.98; 0.47 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Narafilcon B Contact Lens (Device); Spectacles (Device)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Papillary Conjunctivitis |
0.98; 0.47 | — |
| PRIMARY Conjunctival Hyperemia |
0.26; 0.28 | — |
| PRIMARY Limbal Hyperemia |
0.56; 0.30 | — |
| PRIMARY Corneal Staining |
0.26; 0.12 | — |
| PRIMARY Conjunctival Staining |
1.41; 0.39 | — |
| PRIMARY Corneal Neovascularization |
0.30; 0.09 | — |
| PRIMARY Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire |
-4.97; 0.62 | — |
| SECONDARY Comfortable Wearing Time |
10.25 | — |
Summary
The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.
Eligibility Criteria
Inclusion Criteria
- Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).
- Willing to comply with the study visit schedule.
- Ages 15 to 39.
- Has access to a cellular telephone with text messaging capabilities.
- Has a current pair of spectacles.
- 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'.
- Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC.
- Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.
- Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week.
- They agree not to participate in other clinical research during the duration of this study.
Exclusion Criteria
- Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.
- Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).
- Systemic disease, which might interfere with contact lens wear.
- Medication usage that may be associated with eye dryness.
- Use of any topical medication such as eye drops or ointment.
- Pregnant or lactating (by self-report).
- Aphakia.
- Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.
- Have participated in any other clinical trial or research in the two weeks prior to starting this study.
Data sourced from ClinicalTrials.gov (NCT01093625). 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.