A Comparison of Daily Disposable Contact Lenses.
2 other identifiers
interventional
248
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2008
Shorter than P25 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 30, 2008
CompletedFirst Posted
Study publicly available on registry
August 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
February 18, 2010
CompletedMay 21, 2015
May 1, 2015
3 months
July 30, 2008
September 24, 2009
May 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Comfort
Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
at 1 week of wear.
Measured Limbal Hyperemia
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.
at 1 week of wear.
Secondary Outcomes (5)
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 Arms (2)
narafilcon A
ACTIVE COMPARATORspherical soft contact lens worn as a daily disposable modality for one week
nelfilcon A
ACTIVE COMPARATORspherical soft contact lens worn as a daily disposable modality for one week
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johnson & Johnson Vision Care, Inc.lead
- Visioncare Research Ltd.collaborator
Study Sites (19)
Ellis & Killpartrick
Bath, Bath, BA1 1BA, United Kingdom
Simon Donne Opticians 3-4
Bedford, Bedfordshire, MK40 1NS, United Kingdom
Brock & Houlford
Brislington, Bristol, BS4 3LJ, United Kingdom
The Contact Lens Centre
Plymouth, Devon, PL1 1LB, United Kingdom
Keith Tempany Opticians
Broadstone, Dorset, BH18 8DH, United Kingdom
Eyecare
Ilford, Essex, IG1 4DU, United Kingdom
Leightons Opticians
Albans, Herts, AL1 3LH, United Kingdom
Hazel Smith Opticians
Shanklin, Isle of Wight, PO37 6JZ, United Kingdom
Bowden & Lowe
Gillingham, Kent, ME7 2YX, United Kingdom
David Gould Opticians
Rawtenstall, Lancashire, BB4 7QN, United Kingdom
Vision Express Optical Lab
Hendon, London, NW4 3FB, United Kingdom
Hawkes & Wainer
London, London, EC3V 1LT, United Kingdom
City Opticians
London, London, WC2A 1AA, United Kingdom
David H Burns BSC, FCOptom
Tottenham, London, N17 0EY, United Kingdom
First Contact Opticians
Eastcote Pinner, Middlesex, HA5 1RJ, United Kingdom
Tompkins Knight & Son
Northampton, Northampton, NN2 7BL, United Kingdom
Chalmers & Son (Opticians)
Cardiff, South Glamorgan, CF24 3RQ, United Kingdom
Susan R Bowers Opticians
Coventry, West Midlands, CV4 9DU, United Kingdom
Viewpoint
York, York, YO1 8BA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kurt Moody OD, FAAO/ Director
- Organization
- Vistakon
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2008
First Posted
August 4, 2008
Study Start
July 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
May 21, 2015
Results First Posted
February 18, 2010
Record last verified: 2015-05