Status:
COMPLETED
A Comparison of Daily Disposable Contact Lenses.
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Collaborating Sponsors:
Visioncare Research Ltd.
Conditions:
Myopia
Eligibility:
All Genders
18-60 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00727558
Start Date
July 1 2008
End Date
October 1 2008
Last Update
May 21 2015
Active Locations (19)
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1
Ellis & Killpartrick
Bath, Bath, United Kingdom, BA1 1BA
2
Simon Donne Opticians 3-4
Bedford, Bedfordshire, United Kingdom, MK40 1NS
3
Brock & Houlford
Brislington, Bristol, United Kingdom, BS4 3LJ
4
The Contact Lens Centre
Plymouth, Devon, United Kingdom, PL1 1LB