A Comparison of Daily Disposable Contact Lenses.

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
narafilcon A	narafilcon A	spherical soft contact lens worn as a daily disposable modality for one week
nelfilcon A	narafilcon A	spherical soft contact lens worn as a daily disposable modality for one week
nelfilcon A	nelfilcon A	spherical soft contact lens worn as a daily disposable modality for one week

Primary Outcome Measures

Name	Time	Method
Overall Comfort	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	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 Outcome Measures

Name	Time	Method
Overall Handling	at 1 week of wear	Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.
How Comfortable Eyes Feel at the End of the Day	at 1 week wear	Rating of "How comfortable did your eyes feel at the end of the day when wearing the contact lenses provided" using the following scale: 1=extremely uncomfortable, 2= very uncomfortable, 3=slightly uncomfortable, 4=comfortable, 5=very comfortable.
End of Day Comfort	at 1 week of wear	Rating of comfort at the end of the day using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Initial Comfort	at 1 week	Rating of "comfort immediately when you first put them on" using the following scale: 0=N/A, 1= Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.
Inferior Region Corneal Staining	at 1 week of wear	National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.

Locations (19): Brock & Houlford
🇬🇧
Brislington, Bristol, United Kingdom
Eyecare
🇬🇧
Ilford, Essex, United Kingdom
Leightons Opticians
🇬🇧
Albans, Herts, United Kingdom
Bowden & Lowe
🇬🇧
Gillingham, Kent, United Kingdom
David H Burns BSC, FCOptom
🇬🇧
Tottenham, London, United Kingdom
Chalmers & Son (Opticians)
🇬🇧
Cardiff, South Glamorgan, United Kingdom
First Contact Opticians
🇬🇧
Eastcote Pinner, Middlesex, United Kingdom
Ellis & Killpartrick
🇬🇧
Bath, United Kingdom
Viewpoint
🇬🇧
York, United Kingdom
Keith Tempany Opticians
🇬🇧
Broadstone, Dorset, United Kingdom
Hazel Smith Opticians
🇬🇧
Shanklin, Isle of Wight, United Kingdom
The Contact Lens Centre
🇬🇧
Plymouth, Devon, United Kingdom
Vision Express Optical Lab
🇬🇧
Hendon, London, United Kingdom
City Opticians
🇬🇧
London, United Kingdom
Simon Donne Opticians 3-4
🇬🇧
Bedford, Bedfordshire, United Kingdom
David Gould Opticians
🇬🇧
Rawtenstall, Lancashire, United Kingdom
Susan R Bowers Opticians
🇬🇧
Coventry, West Midlands, United Kingdom
Hawkes & Wainer
🇬🇧
London, United Kingdom
Tompkins Knight & Son
🇬🇧
Northampton, United Kingdom