ASA Adjudication on Johnson & Johnson Vision Care Inc

Ad

A magazine ad, for 1 Day Acuvue and 1 Day Acuvue Moist contact lenses, stated "Are you fitting the most comfortable contact lenses?" The ad featured a column headed "Daily Disposables". Text at the bottom of the column stated "Good Other daily disposable". The middle of the column featured a photograph of 1 Day Acuvue contact lenses; the photograph was below the text "Better" and above the text "Excellent comfort and easy handling". The top of the column featured a photograph of 1 Day Acuvue Moist contact lenses; the photograph was below the text "Best" and above the text "A fresh, new contact lens feeling from morning to night". The ad featured two bar charts: the first was headed "Significantly superior comfort than Focus DAILIES with AquaComfort 1" and showed that 1 Day Acuvue Moist out-performed Focus Dailies with AquaComfort in "Overall comfort"; "Comfort at end-of-day"; "Longer wearing time" and "Reduced end-of-day dryness". The second bar chart was headed "Significantly superior comfort than Focus DAILIES with AquaComfort 2" and showed that 1 Day Acuvue out-performed Focus Dailies with AquaComfort in "Overall opinion (Excellent/very good)"; "Lens awareness from morning to night (% not/barely aware)"; "Comfortable each and every day I wore them (% agree)" and "Excellent lens to recommend to others (% agree)". A footnote stated "1 Veys J and Meyler J. Do new daily disposable lenses improve patient comfort? OPTICIAN 2006; 231 (6046), 34-36. 2 Johnson & Johnson Vision Care, data on file 2005. Bilateral crossover study conducted by an independent research group. Lens evaluation after one week ...".

Issue

CIBA Vision (UK) Ltd, who claimed that a clinical evaluation had shown that their product, Focus Dailies All Day Comfort, provided superior comfort to Johnson & Johnson's 1 Day Acuvue Moist, challenged:

1. the claim "Are you fitting the most comfortable contact lenses?" in conjunction with the "Good", "Better" and "Best" claims in the column headed "Daily Disposables" and

2. the two bar charts headed "Significantly superior comfort than Focus DAILIES with AquaComfort".

CAP Code (Edition 11)

Response

1. Johnson & Johnson said they had conducted four studies which supported their claims.

They said the first study, which was carried out at an independent research centre at the University of Manchester, was a bilateral, randomised patient masked crossover study on 48 people. They said the 1 Day Acuvue lens was rated by participants in the survey as being better than Focus Dailies with AquaComfort in the following areas: overall opinion; not being aware of the lens from morning to night-time; comfort at the end of the day; level of dryness at the end of the day; feelings of moisture throughout the day; comfort each and every day worn; extent to which wearer forgot he/she was wearing contact lenses; ease of removing lenses; an excellent lens to recommend to others and percentage of patients who, on an average day, wore the contact lenses comfortably for nine hours.

They said the second study, carried out at an independent research centre, was a bilateral, parallel, randomised patient masked crossover study on 282 people. They said the 1 Day Acuvue lens was rated by participants in the survey as being better than Focus Dailies with AquaComfort in the following areas: overall comfort; comfort immediately when first put on; comfort while working at a computer; not stinging or burning eyes when first put on; absence of irritation throughout the whole day; feeling smooth on the eyes at all times; feeling fresh and new for a longer period throughout the day; less awareness of lens; comfort at the end of the day; level of dryness at the end of the day; not wishing to use rewetting drops; not using rewetting drops; overall fit; overall smoothness and percentage of participants who, on average, wore the contact lenses comfortably for nine hours or more.

They said the third study was a bilateral, randomised patient masked crossover study on 198 people. They said participants had rated 1 Day Acuvue Moist lenses as more comfortable than 1 Day Acuvue lenses in the following areas: feeling fresh and new for longer throughout the day; the need to remove from eyes for comfort reasons before the end of the day; the extent to which they were comfortable; level of dryness experienced at the end of the day; a comfort rating in excess of 90% from those wearing the lens; feeling of moistness throughout the night; the extent to which there was discomfort during the day; the extent to which the lens felt fresh and new throughout the day and the extent to which they were comfortable each and every day they were worn.

They said the fourth study, carried out at an independent research centre, was a bilateral, parallel, randomised patient masked crossover study on 41 people. They said the 1 Day Acuvue Moist lens was rated by participants in the survey as being better than Focus Dailies with AquaComfort in the following areas: overall comfort; comfort at the end of the day; feeling smooth on eyes all the time; feeling fresh and new longer throughout the day; feeling fresh and new all day long; feeling as fresh and new at the end of the day as they did at the beginning of the day and ability to wear contact lenses for a longer time during the day.

They said the second study had been accepted for publication in a peer reviewed journal and the design and results from the first and fourth studies had been published in Optician magazine in April 2006.

2. Johnson & Johnson said the data in the first bar chart had been taken from the fourth study and the data in the second bar chart was taken from the first study.

Assessment

The ASA took expert advice. The expert said, although the first and fourth studies were designed to be masked trials, the contact lenses were contained within their proprietary packaging, not within identical packaging. He said, because all of the subjects of that study were previous contact lens wearers, they could have been familiar with the proprietary packaging of the lenses.

The expert said the second study was a one week study; that period had been chosen because, after the initial fitting of a new contact lens on a patient, an assessment of the lenses would typically be carried out after one week. However, we understood that, because the participants in the trial had previously worn contact lenses, their eyes would have adapted to contact lens wear. The expert considered that it would have been more appropriate to have conducted a cross-over test, where one week of wear with each lens was assessed.

The expert noted the questionnaire used in the second study asked subjects to say how the lenses felt in the eye using categories, such as "soft, smooth, fresh, moist, light, airy, natural and silky", which he considered were synonymous. He considered that the use of those terms was likely to produce questionnaire bias. We understood from Johnson & Johnson that the results from those questions had not been used to support the claims made in the ad.

The expert also noted that, in the four studies, the percentage of questions for which the responses were statistically significant was 11.5%, 41%, 7.8% and 20% respectively; he considered that studies with such a low proportion of responses that were statistically significant were unlikely to be suitable to substantiate the claims. We noted many of the questions in the survey did not relate to comfort and, of the questions that did relate to comfort, 15%, 61%, 23% and 53% of them respectively had responses that were statistically significant; the expert considered that those proportions were still relatively low.

1. Upheld

We considered that readers would understand the claim "Are you fitting the most comfortable contact lenses", in conjunction with the "Good", "Better" and "Best" claims in the column headed "Daily Disposables", to mean that 1 Day Acuvue Moist contact lenses were the most comfortable daily disposable contact lenses available and that 1 Day Acuvue contact lenses were the second most comfortable daily disposable contact lenses available. We considered that readers were unlikely to interpret the claims as health-related or as general superiority claims.

We noted the second study was accepted for publication in a peer reviewed journal some time after the ad first appeared. We also noted, however, the expert was concerned about the time period of that study and believed it would have been more appropriate to have conducted a cross-over test. We noted the expert was also concerned about the masking procedure and the percentage of the results that were statistically significant in the first and fourth studies. We considered that, because our expert had identified problems with the first, second and fourth studies, the data from those studies was not sufficient to substantiate that 1 Day Acuvue Moist and 1 Day Acuvue provided superior comfort to Focus Dailies with AquaComfort.

We were also concerned that Johnson & Johnson had not provided us with evidence that the 1 Day Acuvue product was the most comfortable daily disposable contact lens available. We considered that they had not therefore substantiated that their product was more comfortable than all "other daily disposables".

2. Upheld

We noted the first table was based on data from the fourth study and the second table was based on data from the first study. We noted both graphs were linked to a footnote which explained the source of the data.

We considered that readers would understand from the first bar chart that 1 Day Acuvue Moist had scored better than Focus Dailies with AquaComfort in a clinical trial in the areas of overall comfort; end of day comfort; longer wearing time and reduced end of day dryness and that they could therefore be considered to have "Significantly superior comfort than Focus Dailies with AquaComfort".

We considered that readers would understand from the second bar chart that 1 Day Acuvue had scored better than Focus Dailies with AquaComfort in terms of overall opinion; lens awareness; comfort every day and recommendation to others; they could therefore be considered to have "Significantly superior comfort than Focus Dailies with AquaComfort".

We noted the expert was concerned about the masking procedure and the percentage of the results that were statistically significant in the first and fourth studies. We considered that, because our expert had identified problems with the methodology and results of those studies, it was not appropriate to use data from them in the bar charts headed "Significantly superior comfort than Focus DAILIES with AquaComfort".

On points 1 and 2, the ad breached CAP Code clauses 3.1 (Substantiation), 7.1 (Truthfulness), 18.1 and 18.3 (Comparisons with identified competitors and/or their products).

Action

We told Johnson & Johnson to avoid the implication in future ads that the 1 Day Acuvue product was more comfortable than all other daily disposable contact lenses unless they had robust evidence to substantiate that claim and to remove the two bar charts headed "Significantly superior comfort than Focus DAILIES with AquaComfort" from future ads.

Adjudication of the ASA Council (Non-broadcast)