N/A
N=25
A Comparison of Two Daily Disposable Contact Lenses.
Refractive Error · Myopia
Bottom Line
View on ClinicalTrials.gov: NCT00721500 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Proportion of Eyes Successfully Fit — 0.98; 0.96; 0.96; 0.96 proportion of participant eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- etafilcon A (Device); narafilcon A (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Eyes Successfully Fit |
0.98; 0.96; 0.96; 0.96 | — |
| PRIMARY Lens Fit Decentration |
0.25; 0.22; 0.27; 0.27 | — |
| PRIMARY Lens Tightness on Cornea With Manual Digit Push Up |
44.6; 46.9; 56.3; 58.1 | — |
Summary
This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.
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 (NCT00721500). 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.