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Since daily disposable soft lenses were introduced in Europe in 1995, the simplicity, convenience and clinical benefits of the modality have proved popular with patients and practitioners alike. In 2006, more than one in three new soft lens fits in the UK were daily disposables, although prescribing rates in other European countries varied widely. Industry data shows that daily disposables accounted for nearly half of the UK market value in 2006.
Daily disposable lens wear offers greater convenience and patient satisfaction than other modalities. They have also improved compliance, which is important given non-compliance is a major concern for eye care practitioners.2 Practitioners need to understand in which areas patients are non-compliant, and then specifically target these throughout the fitting and aftercare process. Compared with conventional daily wear, daily disposable contact lens wearers experience improved comfort, better vision, increased wearing times, and fewer unscheduled visits.3 Allergy sufferers have also been shown to experience fewer symptoms and better comfort when wearing daily disposables than with re-usable lenses.
Despite this success, comfort, and in particular dryness, has remained a significant issue. Manufacturers have continued to seek improvements in contact lens technology aimed at alleviating patient symptoms of dryness. Two such products that have emerged in recent years are Focus Dailies All Day Comfort (DAC) from CIBA Vision and 1-day Acuvue Moist from Johnson & Johnson Vision Care.
Following the successful upgrade from original Focus Dailies to the current Focus Dailies All Day Comfort product, CIBA Vision has undertaken further innovation and development to produce a next generation in Dailies AquaComfort Plus (DAC-Plus). This new product uses the same lightstream technology as the previous products, but incorporates three unique triple-action moisturising agents.
New Dailies AquaComfort Plus is the first and only daily disposable contact lens with CIBA Vision's unique Triple Action Moisture using three hydrophilic agents. The first moisturising agent is found in the packaged saline and provides immediate comfort on insertion. The second wetting agent is found within the lens matrix as well as the package saline and, together with the third moisturising agent, provides comfort that lasts throughout the day. These biomimetic wetting agents spread across the lens surface with each blink to provide all day comfort lubricating the lens upon insertion, moisturising the lens throughout the day and refreshing the lens through the end of the day.
This article describes the results of a clinical trial comparing the performance of the new Dailies AquaComfort Plus with that of current Focus Dailies All Day Comfort.
Trial objectives/design
The primary objective was to compare the subjective and objective performance of the new product with that of the current product. Current Focus Dailies All Day Comfort (DAC) contact lens wearers evaluated the new Dailies AquaComfort Plus (DAC-Plus) lens and provided subjective data concerning comfort, handling, vision and preference compared to habitual DAC. Objective data was collected on vision and fit. The intent was to establish that the new product was truly an upgrade relative to its predecessor.
Several previous clinical studies tested DAC-Plus lenses against DAC. In those studies, when DAC-Plus lenses were compared to habitual DAC lenses, Dailies AquaComfort Plus lenses performed significantly better with regard to overall preference, overall vision, comfort on insertion, overall comfort and dryness at end-of-day.
The trial described here was a prospective, unmasked bilateral trial involving 276 subjects at 15 investigational sites in the US and five investigational sites in Germany. Each subject wore the new lenses, Dailies AquaComfort Plus, bilaterally for 10 days in daily wear, daily disposable modality. All subjects were current wearers of Focus Dailies All Day Comfort for at least two months and habitually wore their lenses at least eight hours per day at least five days per week. Subjects were seen for a baseline/dispensing visit and a 10-day final visit. Data on DAC was collected at the baseline visit via a questionnaire on subjects' habitual lens wearing experience as well as investigator assessments of habitual lens fit. The test and control lens specifications are summarised in Table 1.
Trial results
Two-hundred and seventy-six (276) subjects were enrolled and dispensed lenses. Two-hundred and seventy-three (273) completed the trial, three discontinued the trial.
The new DAC-Plus was rated significantly better than habitual DAC lenses for insertion comfort, end-of-day comfort, overall comfort, end-of-day dryness, lenses staying moist throughout the day and ease of insertion. Overall vision was significantly better for DAC-Plus at dispensing, but was similar to habitual DAC at follow-up. Ease of removal differed by region, and was found to be significantly better for DAC-Plus in the US. In Germany, DAC-Plus was rated similar to DAC for ease of removal. Comfort during the day was also similar between DAC-Plus and habitual DAC.
New Dailies AquaComfort Plus was preferred more often by a statistically significant margin for every attribute that was tested, including all comfort, vision and handling attributes as well as overall preference. Figures 1-6 summarise the preference results.
Subjects were asked to compare the test Dailies AquaComfort Plus lenses to their habitual lenses with regard to the statements 'comfortable all day', 'comfortable at end-of-day', 'provide immediate comfort upon insertion,' 'feel fresh and clean throughout the day,' and 'stay moist throughout the day.' A significant majority of subjects rated each of these attributes 'better' for Dailies AquaComfort Plus (Figure 7).
Almost twice as many subjects indicated that they 'never' experienced dryness during the day with Dailies AquaComfort Plus (DAC-Plus) lenses compared to their habitual Focus Dailies All Day Comfort (DAC) lenses, and almost three times as many indicated that they 'never' experienced dryness at the end of the day with DAC-Plus compared to their habitual DAC (Figure 8).
Visual acuity (VA)
VA was similar for Dailies AquaComfort Plus and Focus Dailies All Day Comfort overall.
Centration/overall fit
Dailies AquaComfort Plus parameters of 8.7/14.0 are slightly flatter while also slightly larger than current Focus Dailies with AquaComfort parameters of 8.6/13.8. Slightly larger would make the lenses slightly tighter, which would be expected to counterbalance the flatter base curve. These similar parameters are theoretically comparable in fit, however, it was of interest for CIBA Vision to confirm that refitting would not be required (under supervision of their eye care practitioner) for patients switching to the upgraded product.
The large majority of both lenses were centred. On average, centration was the same between DAC Plus and DAC. Most Dailies AquaComfort Plus and Focus Dailies All Day Comfort lenses displayed an optimal fit. Overall, fit data for Dailies AquaComfort Plus and Focus Dailies All Day Comfort was the same.
A direct comparison of habitual DAC and DAC-Plus on the same eyes showed that, on average, over 98 per cent of eyes, fit (centration and optimal fitting as rated by the practitioner) was similar (within one grade) with both products (Figures 9 and 10).
Safety
Bulbar and limbal redness as well as corneal and conjunctival staining were assessed at baseline and follow-up. The frequency and severity of biomicroscopy findings in this trial was low and similar from baseline (habitual DAC lenses) to exit (DAC Plus lenses).
Conclusion
As manufacturers continue to address the most important unmet consumer need of comfortable contact lens wear, new contact lenses continue to emerge in the market. New Dailies AquaComfort Plus from CIBA Vision has raised the comfort level in the Dailies family.
In this study, for the vast majority of ratings, the new Dailies AquaComfort Plus performed significantly better than Focus Dailies All Day Comfort. In addition, Dailies AquaComfort Plus was preferred significantly more often for all measures tested, including comfort, vision and handling. DAC Plus was preferred over 5 to 1 for all day comfort, and over 4 to 1 for overall comfort.
Based on these results, the overall performance of Dailies AquaComfort Plus lenses is superior to that of Focus Dailies All Day Comfort attributable to the unique triple action moisturisers within the new lens. These biomimetic wetting agents spread across the lens surface with each blink to provide all day comfort lubricating the lens upon insertion, moisturising the lens throughout the day and refreshing the lens through the end of the day.
Given the success of the Focus Dailies with AquaComfort product, it can be expected that the new Dailies AquaComfort Plus will once again be a successful improvement in the quest for truly comfortable and problem-free daily disposable contact lens wear.
References
- CIBA Vision data on file data source-fits tracking UK, MAT Dec, 2006 - check comment from Mark D.
- Bailey GM, Shovlin JP. Compliance and contact lenses. Review of Cornea and Contact Lenses, 2006 Mar:2-3.
- Veys J. Managing the contact lens wearing allergy sufferer. Optician, 2004227(5950):22-6.
- Stiegemeier MJ, Thomas S. Seasonal allergy relief with daily disposable lenses. Contact Lens Spectrum, 2001 (April)24-8.
- CIBA Vision data on file 2007.
? Dr Timothy Giles is global head professional marketing for Dailies