N/A
N=80
Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population
Refractive Error · Myopia
Bottom Line
View on ClinicalTrials.gov: NCT00708643 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcome: Primary: Limbal Hyperemia — 34.0967; 31.0920 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Habitual Silicone Hydrogel Contact Lens (Device); narafilcon A (Device)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Limbal Hyperemia |
34.0967; 31.0920 | — |
| PRIMARY Lens Comfort |
1.1078; 1.0274 | — |
| PRIMARY Upper Lid Margin Staining |
0.9358; 1.1586 | — |
| SECONDARY Tarsal Roughness |
30.1028; 31.3624 | — |
| SECONDARY Tarsal Hyperemia |
38.4103; 37.5478 | — |
| SECONDARY Corneal Staining |
6.6173; 6.3763 | — |
Summary
This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.
Eligibility Criteria
Inclusion Criteria
- They are of legal age (17 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 (NCT00708643). 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.