A Comparison of Two Daily Disposable Contact Lenses

NCT00634101 | Terminated Results FDA Device

• 2 other identifiers: CR-0716DISP-519
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 20

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.

Conditions

Refractive Error; Myopia

Outcome Measures

Primary Outcomes (12)

• Comfort at the End of the Day

  Comfort at the end of the day was assessed by the individual questionnaire item "Comfort at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. EOD Comfort was also assessed by the individual item "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" with the respopnse categories of 1=Extremely Uncomfortable, 2=Very Uncomfortable, 3=Slightly Uncomfortable, 4=Comfortable and 5= Very Comfortable. The number of participants that responsed in each cateogry for each item was reported.

  1-Week Follow-up

• Limbal Hyperaemia

  Limbal Hyperaemia was measured using Efron Grading Scale ranges from 0 to 4 with 0.5 units increments (0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe).

  1-Week Follow-up

• Comfort Immediately When You First Put Them on

  Comfort immediately when you first put them on was assessed by the individual questionnaire item "Comfort immediately when you first put them on" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

  1-Week Follow-up

• Comfort Throughout the Day

  Comfort throughout the day was assessed by the individual questionnaire item "Comfort throughout the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

  1-Week Follow-up

• Lack of Dryness at the End of the Day

  Lack of dryness at the end of the day was assessed by the individual questionnaire item "Not making your eyes feel dry even at the end of the day" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

  1-Week Follow-up

• Overall Opinion

  Overall opinion was assessed by the individual questionnaire item "Considering your experience with the contact lenses you were provided, which statement best describes your overall opinion of these contact lenses? " with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

  1-Week Follow-up

• Overall Comfort

  Overall comfort was assessed by the individual questionnaire item "Overall Comfort" with the response cateogries 1=Poor, 2=Fair, 3=Good, 4=Very good and 5=Excellent. The number of participants that responsed in each cateogry was reported.

  1-Week Follow-up

• My Lenses Stayed Moist

  My Lenses Stayed Moist was assessed by the individual questionnaire item "They stayed moist and smooth, even after long hours at the computer" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.

  1-Week Follow-up

• I Forgot i Was Wearing Lenses Was

  I forgot i was wearing lenses was assessed by the individual questionnaire item "They made me forget that I was wearing contact lenses" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.

  1-Week Follow-up

• Mainted Natural Moisture

  Mainted natural moisture was assessed by the individual questionnaire item "They maintained my eyes' own natural moisture" with the response cateogries 1=Disagree Strongly, 2=Disagree Somewhat, 3=Neither Agree Nor Disagree, 4=Very Somewhat and 5=Agree Strongly. The number of participants that responsed in each cateogry was reported.

  1-Week Follow-up

• Comfort While Wearing Lenses in Heat/Air Conditioned Environments

  Comfort while wearing lenses in heat/air conditioned environments was assessed by the individual questionnaire item "How often are you comfortable while sitting under or near an air conditioning vent or heating vent " with the response cateogries 0=Not Applicable, 1=Always, 2=Frequently, 3=Occasionally, 4=Rarely and 5=never. The number of participants that responsed in each cateogry was reported.

  1-Week Follow-up

• Dryness at the End of the Day

  Dryness at the end of the day was assessed by the individual questionnaire item "How dry did your eyes feel at the end of the day when wearing the contact lenses you were provided" with the response cateogries 1=Extremely Dry, 2=Very Dry, 3=Moderately Dry, 4=Slightly Dry and 5=Not Dry at All. The number of participants that responsed in each cateogry was reported.

  1-Week Follow-up

Secondary Outcomes (1)

• Overall Handling

  1-Week Follow-up

Study Arms (2)

nefilcon A

ACTIVE COMPARATOR

Subjects randomized to this arm received the nelfilcon A lens throughout the entire duration of the study.

Device: nelfilcon A

narafilcon A

EXPERIMENTAL

Subjects randomized to this arm received the narafilcon A lens throughout the entire duration of the study.

Device: narafilcon A

Interventions

nelfilcon A DEVICE

contact lens

Also known as: FOCUS DAILIES AquaComfort Plus

nefilcon A

narafilcon A DEVICE

contact lens

Also known as: Experimental Contact Lens

narafilcon A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Visioncare Research Ltd.: collaborator

Study Sites (20)

Simon Donne Opticians

Bedford, Bedfordshire, MK40 1NS, United Kingdom

Location

Brock & Houlford

Brislington, Bristol, BS4 3LJ, United Kingdom

Location

Keith Tempany Opticians

Broadstone, Dorset, BH18 8DH, United Kingdom

Location

Cole Martin Tregaskis Optometrists

Brentwood, Essex, CM15 8AG, United Kingdom

Location

Specsavers Opticians

Colchester, Essex, CO1 1LJ, United Kingdom

Location

Eyecare

Ilford, Essex, IG1 4DU, United Kingdom

Location

Cameron-Davies Optometrists

Southsea, Hants, PO5 2AT, United Kingdom

Location

Leightons Opticians

St Albans, Herts, AL1 3LH, United Kingdom

Location

Hazel Smith Opticians

Shanklin, Isle Of Wight, PO37 6JZ, United Kingdom

Location

David Gould Opticians

Rawtenstall, Lancashire, BB4 7QN, United Kingdom

Location

Vision Express Optical Lab

Hendon, London, NW4 3FB, United Kingdom

Location

City Opticians

Holborn, London, WC2A 1AA, United Kingdom

Location

David H. Burns, BSC, FCOptom

Tottenham, London, N17 0EY, United Kingdom

Location

First Contact Opticians

Pinner, Middlesex, HA5 1RJ, United Kingdom

Location

S.H. Harrold

Uxbridge, Middlesex, UB81JX, United Kingdom

Location

Dipple & Conway Opticians

Norwich, Norfolk, NR2 1PB, United Kingdom

Location

Tompkins Knight & Son

Northampton, Northamptonhsire, NN2 7BL, United Kingdom

Location

Chalmers & Sons (Opticians)

Cardiff, South Glamorgan, CF24 3RQ, United Kingdom

Location

Boots Opticians Ltd

Birmingham, West Midlands, B4 7TB, United Kingdom

Location

Viewpoint

York, YO1 8BA, United Kingdom

Location

MeSH Terms

Conditions

Refractive Errors; Myopia

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: DIR CLINICAL NEW PRODUCT DEVELOPMENT
• Organization: Johnson & Johnson Vision

KMoody1@its.jnj.com

1-800-843-2020

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• 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: February 28, 2008
• First Posted: March 12, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: January 6, 2021
• Results First Posted: October 14, 2020

Record last verified: 2020-12

Locations

GB (20)