N/A
N=74
Clinical Performance of a New Daily Disposable Contact Lens Worn in a Neophyte Population.
Refractive Error · Myopia
Bottom Line
View on ClinicalTrials.gov: NCT00708032 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Papillary Conjunctivitis — 1.22; 1.04 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- spectacles (Device); narafilcon A soft contact lenses (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Papillary Conjunctivitis |
1.22; 1.04 | — |
| SECONDARY Biomicroscopy Findings After 12 Months of Daily Wear From Slit Lamp Analysis. |
1.09; 1.00; 0.89; 0.80; 0.00; 0.00 | — |
| SECONDARY Visual Acuity After 12 Months of Wear |
-0.05; -0.11; 0.29; 0.18 | — |
| SECONDARY Subjective Overall Comfort After 12 Months of Daily Wear |
87.8; 82.2 | — |
| SECONDARY Subjective Overall Vision After 12 Months of Daily Wear |
88.7; 82.5 | — |
Summary
This study seeks to evaluate the impact of wearing a new daily disposable soft contact lens on the neophyte population.
Eligibility Criteria
Inclusion Criteria
- They are of legal age (18 years) and capacity to volunteer.
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
- They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
- They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
- They have successfully worn contact lenses within six months of starting the study.
Exclusion Criteria
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They are aphakic.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
- They are pregnant or lactating.
- They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
- They have diabetes.
- They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Data sourced from ClinicalTrials.gov (NCT00708032). 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.