A New Standard In Lens Hygiene

BY EVAN THOMAS, O.D.; HAROLD STEIN, M.D.; DOUGLAS COX, O.D.; JAMES KEY, M.D.; ROBERT KENNEDY, O.D.; GARY MEIER, O.D.; CHERYL VINCENT, O.D.; DONALD HOOD, O.D.; RHEDA GERLOCK, O.D.; DOUGLAS HERRIOTT, O.D.; STEVEN GRANT, O.D.;JAMES MCCULLEY, M.D.; CARL GILBERT, O.D.; PATRICIA BENJAMIN, O.D.; ERIC WHITE, O.D.; THOMAS CUSHING, O.D.; MARIANNE ANDERSON, O.D.; CRAIG SMITH, M.D.
NOV. 1996

Three clinical studies evaluate SupraClens, a new liquid daily protein remover, for cleaning efficacy, safety, comfort and convenience.Multipurpose solutions have become increasingly popular over the last five years, although many practitioners view them as a compromise between cleaning efficacy and convenience. A new, market-approved daily protein remover, Opti-Free SupraClens Daily Protein Remover by Alcon, was designed to complement the cleaning efficacy of a multipurpose solution without sacrificing convenience.

SupraClens is a liquid formulation of purified pancreatin. One drop added to Opti-Free Express Multi-Purpose Solution directly in each side of the lens case allows simultaneous deposit removal and chemical disinfection without separate vials (Fig. 1). Users can combine daily digital cleaning and in-the-lens-case protein removal for maximum cleaning potential.

STUDY 1: LONG-TERM SAFETY & CLEANING EFFICACY

We enrolled 268 patients in a six-month, open-label study involving 12 clinical centers to compare the performance of the SupraClens regimen to a historical control. The control represented combined results from two studies (n=413) involving full lens care regimens (i.e., daily cleaner; rinsing, disinfecting, storage solution; weekly enzymatic cleaning tablet). All participants were adapted conventional daily or extended lens wearers having normal, healthy eyes.

At the start of the study, we dispensed a new pair of contact lenses (Group I or IV) to each patient, provided them with the study solutions and instructed them on their proper use.

The care system consisted of Opti-Free Express Multi-Purpose Solution for cleaning (rubbing), rinsing, disinfecting and storing the lenses, combined with SupraClens for use daily or each time extended wear lenses were removed.

We instructed participants to clean and rinse their lenses with Opti-Free Express, place them in a lens case with five millileters of Opti-Free Express, and add one drop of SupraClens to each lens case well during disinfection.

We scheduled follow-up visits at days 14, 30, 60, 90, 135 and 180. Each visit included slit lamp examination and assessment of lens cleanliness using modified Rudko criteria.

Lenses cleaned using the SupraClens regimen had statistically higher cleanliness (p¾0.02) compared to the control (Fig. 2), with statistically significant differences favoring SupraClens noted as early as day 60 and persisting throughout the study.

Nearly all the SupraClens users (97%) had clinically clean lenses at six months. For this study, we defined a clinically clean lens as Rudko ratings Type I (no deposits) or Type II (microscopic deposits identified using 7-10x magnification).

We had no reports of patients experiencing regimen-related sensitization or serious adverse events. Two patients (0.7%) exhibited mild to moderate intolerance to the regimen.

STUDY 2: COMFORT & VISUAL CLARITY EQUIVALENT TO NEW LENSES

At the conclusion of the six-month safety and efficacy investigation, 239 patients rated comfort and visual performance of their lenses cleaned with the SupraClens regimen. We then dispensed new lenses identical to those worn during the six-month investigation and instructed patients to wear them for less than one week. Lens care during this period was consistent with the preceding six months; however, patients used Opti-Free Express Multi-Purpose Solution for cleaning without SupraClens. Comfort and visual clarity associated with the six-month lenses were compared to the new lenses worn less than one week using paired t-tests with a 95 percent confidence level.

Comfort and visual clarity of the six-month lenses that were cleaned with the SupraClens regimen were statistically equivalent to new lenses worn less than one week (Figs. 3, 4 & 5).

In fact, patient assessment of comfort (i.e., lens awareness, ocular awareness) and visual clarity were numerically better with use of the SupraClens regimen. When using the SupraClens regimen, patients agreed that:

• Lens care was easier (95.4%) and had easy instructions (99.6%).

• Lenses felt clean (94.6%) and comfortable when inserted (95.0%).

• Lenses felt refreshed (82.8%), comfortable at the end of the day (82.4%) and comfortable all day (84.5%).

STUDY 3: CONVENIENCE

We enrolled 106 adapted wearers of Group IV lenses in a one-month, randomized, parallel study to compare convenience of the SupraClens regimen (used daily) to a traditional system involving an enzyme tablet cleaner. The traditional regimen included daily use of Bausch & Lomb's ReNu Multi-Purpose Solution and a weekly, two-step, enzymatic tablet cleaner. At the final visit, we asked patients to evaluate complexity, ease of use, overall convenience, and requirements for dexterity and time on a nine-point scale. Patients judged the SupraClens regimen to be significantly more convenient than the multipurpose solution/weekly tablet enzyme system (Fig. 6). Significant differences favoring the SupraClens regimen were evident in all five categories (p<0.05).

SATISFYING PATIENT NEEDS AND PRACTITIONER DEMANDS

As practitioners, we are rightfully concerned with the efficacy of the products we prescribe, but we also know that the most efficacious product must be used before patients can experience the benefits. Opti-Free SupraClens Daily Protein Remover was designed to satisfy patient needs for convenience and practitioner demands for efficacy. As shown in these studies, daily use of SupraClens is well-tolerated and complements the cleaning of Opti-Free Express Multi-Purpose Solution without compromising convenience. Daily digital cleaning with a multipurpose solution and in-the-lens-case protein removal was associated with exceptional lens cleanliness over a six-month period.

The SupraClens regimen provides daily, dual-action protein removal which will likely minimize consequences associated with lens deposits which can include giant papillary conjunctivitis, discomfort, reduced visual acuity and shortened lens life.

Since new contact lenses are associated with excellent comfort and performance, patients undoubtedly would like their lenses to remain like new over the prescribed wearing schedule. Using the SupraClens regimen, patients reported that the comfort and visual clarity of six-month old lenses was statistically equivalent to new lenses worn less than one week.

Convenience of the SupraClens regimen was superior to a traditional multipurpose solution/weekly enzyme tablet regimen when factors such as complexity, dexterity, ease of use, time required and overall convenience were evaluated. Ninety-five percent of patients indicated that the SupraClens regimen made lens care easier, and 99 percent of patients agreed the instructions were easy to follow. Our patients and staff liked the fact that the same set of lens care instructions could be used every day with no special, end-of-week steps. High satisfaction associated with using the SupraClens regimen may enhance patient retention.

These clinical studies demonstrate that the SupraClens regimen provides high levels of cleaning, convenience, comfort and safety. Collectively, these results underscore the ability of this regimen to keep lenses feeling like new, longer. A simplified method for maintaining clean, comfortable lenses will likely reinforce routine compliance. CLS

These three multicenter studies evaluating the SupraClens regimen were sponsored by Alcon Laboratories, Ft. Worth, Texas.