A Comparison of Daily Disposable Contact Lenses.

Condition(s): Myopia
NCTId: NCT00727558

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

Eligibility Criteria

Gender Minimum Age Maximum Age Healthy Volunteers?
Both 18 Years 60 Years False

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.

Interventions & Outcomes

Study Interventions & Types

Device Intervention(s)

narafilcon A - spherical soft contact lens
nelfilcon A - spherical soft contact lens

Study Outcomes

Primary Outcome(s)

Timeframe: at 1 week of wear.
Measure: Measured Limbal Hyperemia
Description: 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.
Safety Issue? No

Timeframe: at 1 week of wear.
Measure: Overall Comfort
Description: Single question: Comfort scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent
Safety Issue? No

Secondary Outcome(s)

Measure: End of Day Comfort
Timeframe: at 1 week of wear
Description: 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
Safety Issue? No

Measure: How Comfortable Eyes Feel at the End of the Day
Timeframe: at 1 week wear
Description: 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.
Safety Issue? No

Measure: Inferior Region Corneal Staining
Timeframe: at 1 week of wear
Description: National Eye Institute (NEI) 0-3 scale: grade 0=normal, grade 1=mild, grade 2=moderate, grade 3=severe.
Safety Issue? No

Measure: Initial Comfort
Timeframe: at 1 week
Description: 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.
Safety Issue? No

Measure: Overall Handling
Timeframe: at 1 week of wear
Description: Rating of overall ease of handling using the following scale: 0=N/A, 1=Poor, 2=Fair, 3=Good, 4=Very Good, 5=Excellent.
Safety Issue? No

Facility Locations

Research Study Facility Map

Map of facility locations for this research study.

Facility is recruiting
Facility is not yet recruiting
Unknown status
First 15 facilities are shown on map

Clinical Research Study Facility Locations

Viewpoint
York, YO1 8BA United Kingdom

Tompkins Knight & Son
Northampton, NN2 7BL United Kingdom

Hawkes & Wainer
London, EC3V 1LT United Kingdom

City Opticians
London, WC2A 1AA United Kingdom

Ellis & Killpartrick
Bath, BA1 1BA United Kingdom

Susan R Bowers Opticians
Coventry, West Midlands CV4 9DU United Kingdom

Chalmers & Son (Opticians)
Cardiff, South Glamorgan CF24 3RQ United Kingdom

First Contact Opticians
Eastcote Pinner, Middlesex HA5 1RJ United Kingdom

David H Burns BSC, FCOptom
Tottenham, London N17 0EY United Kingdom

Vision Express Optical Lab
Hendon, London NW4 3FB United Kingdom

David Gould Opticians
Rawtenstall, Lancashire BB4 7QN United Kingdom

Bowden & Lowe
Gillingham, Kent ME7 2YX United Kingdom

Hazel Smith Opticians
Shanklin, Isle of Wight PO37 6JZ United Kingdom

Leightons Opticians
Albans, Herts AL1 3LH United Kingdom

Eyecare
Ilford, Essex IG1 4DU United Kingdom

Keith Tempany Opticians
Broadstone, Dorset BH18 8DH United Kingdom

The Contact Lens Centre
Plymouth, Devon PL1 1LB United Kingdom

Brock & Houlford
Brislington, Bristol BS4 3LJ United Kingdom

Simon Donne Opticians 3-4
Bedford, Bedfordshire MK40 1NS United Kingdom

Related Keywords & Studies

Conditions and Diseases with Related Research Studies

  1. Myopia

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