A Comparison of Two Daily Disposable Contact Lenses

Johnson & Johnson Vision Care, Inc.129 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

129

Conditions

Refractive Error Myopia

Interventions

nelfilcon ADEVICE

contact lens

narafilcon ADEVICE

contact lens

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. They are of legal age (18 years) and capacity to volunteer. 2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses. 5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS. 6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC). 7. They have successfully worn contact lenses within six months of starting the study. Exclusion Criteria: 1. They have an ocular disorder which would normally contra-indicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are using any topical medication such as eye drops or ointment. 4. They are aphakic. 5. They have had corneal refractive surgery. 6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus. 7. They are pregnant or lactating. 8. 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. 9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV). 10. They have diabetes. 11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Locations (20)

Simon Donne Opticians

Bedford, Bedfordshire, United Kingdom

Brock & Houlford

Brislington, Bristol, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Keith Tempany Opticians

Broadstone, Dorset, United Kingdom

Cole Martin Tregaskis Optometrists

Brentwood, Essex, United Kingdom

Specsavers Opticians

Colchester, Essex, United Kingdom

Eyecare

Ilford, Essex, United Kingdom

Cameron-Davies Optometrists

Southsea, Hants, United Kingdom

Leightons Opticians

St Albans, Herts, United Kingdom

Hazel Smith Opticians

Shanklin, Isle Of Wight, United Kingdom

David Gould Opticians

Rawtenstall, Lancashire, United Kingdom

...and 10 more locations

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 1-Week Follow-up

Secondary Outcomes

Overall Handling

Handling was assessed through opinion of handling in the final questionnaire. There were 5 categories Excellent (5), Very Good (4), Good (3), Fair (2) and Poor (1).

Time frame: 1-Week Follow-up