Features

Clinical evaluation of the Biomedics 1 Day

Lenses
John Rogers, Karl Aberdeen and Henrik Bo Larsen review some recent results on patient response when changing to the Biomedics daily contact lens

The last year has seen a steady release of new daily disposable lenses from both existing and new manufacturers. A market that historically was dominated by two players now has more than nine companies offering lenses.

Two of the new daily disposables, Focus Dailies All Day Comfort and 1 Day Acuvue Moist, have included comfort agents to improve the performance of the lenses. These lenses have been shown to offer improved comfort to the daily disposable wearer. fig1a

Independent market research conducted at the beginning of 2006 of current contact lens wearers across Europe shows that 51 per cent of daily disposable wearers rank comfort as the single most important attribute they would still like to see improved about their lenses. Overall, 71 per cent of wearers choose comfort as one of the top three attributes they would like to see improved.

The other factor to consider is that as daily lenses become more accessible the frequency of wear is increasing with many wearers wearing the lenses seven days a week (Figure 1). Overall 44 per cent of daily disposable wearers reported wearing their lenses every day, with a further 26 per cent almost every day.

Biomedics 1 Day Lens

The Biomedics 1 Day lens is made from the Ocufilcon B material, which is 52 per cent water content and contains both a UV inhibitor and handling tint.

The manufacturing platform of the lens allows for full control of the lens design. This results in a lens that has an optimal back surface design to improve ease of fitting and a controlled edge design to enhance lens comfort.

The lens does not contain a comfort agent within the lens material. Neither is a comfort agent included in the solution within the lens blister. The lens has also recently been improved with the packaging upgraded to a strip blister format. The in-market study was designed to compare the performance of the lens against currently available daily disposable lenses including those containing comfort agents.

Study Design

The study was conducted in 11 centres in the UK and Nordic region, with a total of 164 current wearers. These were split into 131 Focus Dailies All Day Comfort, 15 wearing 1 Day Acuvue and 18 in other brands. For comparison, data is presented against Focus Dailies All Day Comfort and overall as the number of wearers of other products was not felt to be significant enough for individual comparison.

Protocol for the study was approved by the BCLA Ethics Committee in the UK.

The study involved the wearer trying the test lens for a one-week period as per their current wearing frequency. This was designed to ensure that the assessment was as close to the 'real world' as is feasible.

At the initial visit, baseline readings and fit assessment were conducted. Additionally, the wearer was asked to comment on the handleability and comfort of the test lenses.

At the follow-up visit, the lens fit was again assessed and the practitioner was asked to rate this against the wearer's previous daily disposable lens.

At this stage the wearer was asked to complete a questionnaire to assess the vision, comfort, handling and overall performance of the lens compared to their previous lens. The questionnaire asked questions on a grading from very poor to excellent and also much worse to much better compared to their previous lens.

Study Results

All of the wearers successfully completed the trial. At the initial visit, ease of fitting of the lens was rated by the practitioner as easy or very easy for all wearers. Seventy three per cent of fits had centration rated as good, with the rest being adequate and 97 per cent had good movement, with 2 per cent excessive and 1 per cent rated as tight. At the follow-up visit, the practitioner was asked to grade the lens compared to the previous one day lens worn by the patient. fig3

A total of 31 per cent of patients were rated as better or much better with 66 per cent rating it as equal to the previous lens (Figure 2)

At the follow-up visit the wearer was asked to complete a questionnaire to assess the lens performance over the week. The amount of days lenses were worn is shown in Figure 3. fig2

Comfort was assessed overall and end of day, 84 per cent of wearers rated overall comfort as excellent or good and 71 per cent rated end of the day excellent or good.

Figure 4 shows the comparison for overall comfort and end of day comfort versus their previous lenses with 89 per cent rating end of day comfort and 87 per cent rating overall comfort as equal or better than their previous lens.

For other attributes, 91 per cent of wearers rated the distance vision as excellent or good with 95 per cent rating it as better or equal to their previous lens. A total of 90 per cent rated handling as excellent or good with 93 per cent rating it as better or equal to their previous lens. Ten per cent of wearers stated they could wear the lens longer than their previous lens, with another 86 per cent saying they wore them as long, only 4 per cent of wearers reported they couldn't wear the lens as long as their previous lens.

fig4

For overall lens performance, 46 per cent rated it as better than their previous lens, with an additional 42 per cent rating it as equal to their previous lens. Further details are shown in Figure 5.

FIG5

Further analysis of the data also showed a stronger preference towards the new lens by more frequent wearers of daily disposable lenses. Full details are shown in Figure 6. fig6

Discussion

Contact lens wearers continue to look for better comfort from their lenses. Comfort agents have been one way to address this. However, there are other ways to improve the comfort and performance of lenses.

Biomedics 1 Day achieves its performance through optimisation of the lens design to the material and manufacturing process. This creates a lens that offers superior comfort to the Focus Dailies All Day Comfort lens. Also, the study showed that wearers wearing lenses more often in a week had a stronger preference for the Biomedics 1 Day than the less frequent users.

With daily disposable wearers now starting to wear lenses more often, lens performance will become more important. To ensure wearers get a lens that meets their needs, a real world evaluation is needed where they wear the lenses as often as they plan in a week.

A short trial of a lens may result in the wearer choosing a lens which then doesn't perform to their actual wearing needs and frequency and can often lead to reduced loyalty and the wearer leaving the practice.

John Rogers is European clinical affairs manager, Karl Aberdeen is UK & Northern Ireland professional relations manager and Henrik Bo Larsen professional services manager Nordic Area at CooperVision