NCT00727558
Completed
Not Applicable
A Comparison of Daily Disposable Contact Lenses.
ConditionsMyopia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Enrollment
- 248
- Locations
- 19
- Primary Endpoint
- Overall Comfort
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study seeks to evaluate the clinical performance of a new CE marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.
Investigators
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.
Outcomes
Primary Outcomes
Overall Comfort
Time Frame: at 1 week of wear.
Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Measured Limbal Hyperemia
Time Frame: at 1 week of wear.
Measurement of redness of the limbus, graded using half-grade increments using the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.
Secondary Outcomes
- Overall Handling(at 1 week of wear)
- How Comfortable Eyes Feel at the End of the Day(at 1 week wear)
- End of Day Comfort(at 1 week of wear)
- Initial Comfort(at 1 week)
- Inferior Region Corneal Staining(at 1 week of wear)
Study Sites (19)
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