Investigating a New Lens Care Combination
This study evaluates the safety, efficacy and patient acceptance of a new regimen -- the use of SupraClens daily liquid protein remover with ReNu MultiPurpose solution.
BY RONALD K. WATANABE, OD
DECEMBER 1998
the trend in soft lens care has moved toward the development of easier-to-use multipurpose solutions that encourage better patient compliance. The use of weekly enzymatic cleaners is one aspect of soft contact lens care that has historically proved cumbersome for patients. While many patients have been switched into disposable lens modalities, theoretically reducing their dependency on enzymatic cleaners, it is estimated that as many as 40 percent of all soft lens wearers replace their lenses no more than twice per year and as many as 81 percent of patients replace them monthly or less frequently. Regardless of the frequency of lens replacement, enzymatic protein cleaning should occur daily.
SupraClens daily protein remover, manufactured by Alcon Laboratories, was developed to try to meet the goals of more frequent contact lens replacement and more convenient enzyming regimens. SupraClens is a daily-use liquid enzymatic cleaner that is added as one drop to the lens case for overnight contact lens storage and disinfection. SupraClens is approved for use with Opti-Free Express, Opti-One and Opti-Soak.
Because contact lens patients may benefit from the use of a daily enzymatic cleaner, a study was undertaken to establish the safety, efficacy and acceptance of using Alcon's SupraClens with Bausch & Lomb's ReNu MultiPurpose solution.
Methods
Sixty-two patients (47 female and 15 male, ages 16 to 55 years) were recruited for this three-month evaluation. All subjects were adapted soft lens wearers (one month minimum), successfully using ReNu for at least a two-week period prior to enrollment. Subjects were dispensed new lenses of either group I (low water non-ionic) or group IV (high water ionic) materials consistent with their prior lens usage. They were instructed to wear the lenses without replacement on a daily wear basis for three months. Patients were also instructed to clean and disinfect their lenses daily using the ReNu system and to add one drop of SupraClens to each compartment of the contact lens case daily, as directed by the lens care product manufacturers. Follow-up visits were scheduled for one week, one month, two months and three months. Subjective symptoms and comfort were assessed at each visit along with visual acuity and a slit lamp evaluation. At the final visit, the lenses were visually inspected for the presence of deposits. Additionally, subjects were asked to report their perception of regimen convenience and overall contact lens comfort.
Results
Fifty-nine subjects completed the clinical investigation. Overall, 97.4 percent of the contact lenses were free of deposits as seen with the unaided eye at the final visit. Although 18 contact lenses had to be replaced during the course of the study (13 lenses were damaged during patient handling, two required prescription changes, two lenses were defective and one was lost), none were replaced due to lens deposits.
Three patients were discontinued from the study. One experienced burning and stinging, itching, lens awareness, foreign body sensation and clinically significant tarsal abnormality after two days of lens wear. The second patient reported burning and stinging after 54 days of wear and was found to have mild injection and clinically significant tarsal abnormality. The third patient was lost to follow-up. There were no other significant slit lamp findings (grade 2 or above). With limited exceptions unrelated to contact lens care regimen (unanticipated toric contact lens rotation or contact lens with defective optics), visual acuity was unchanged from baseline values throughout the study.
Investigators also asked participants at each visit to rate their contact lenses as either very comfortable, comfortable or uncomfortable. At all four follow-up visits, patients almost universally described their contact lenses as either very comfortable (58.2%) or comfortable (40.6%). Lastly, the subjects indicated their perception of regimen convenience and overall comfort through their response to four acceptability statements (see chart above). Their response to each question was on a five-point Likert scale (strongly disagree, disagree, undecided, agree, strongly agree). Overall, between 83.1 percent and 98.3 percent of responses were favorable.
Strongly Agree/Agree (%) |
|
STATEMENT 1: Your Lenses are comfortable at the end of the |
83.1 |
STATEMENT 2: Your Lenses are comfortable all day long |
93.2 |
STATEMENT 3: Your lenses feel clean |
94.9 |
STATEMENT 4: Thes products make your lens care easier |
96.3 |
A Suitable Combination
This three-month evaluation provides evidence that using Alcon's SupraClens with Bausch & Lomb's ReNu MultiPurpose solution constitutes a suitable lens care regimen. By including both group I and group IV contact lens materials, the most commonly prescribed soft contact lens types were represented in this investigation, thereby making these results more broadly applicable. The study showed that over 97 percent of the contact lenses were free of visible deposits at the end of three months of wear, with no lens replacements needed due to excessive lens deposits. Overall comfort appeared acceptable, with over 98 percent of subjects rating their contact lenses as very comfortable or comfortable throughout the study. Moreover, almost 95 percent of patients agreed that this lens care regimen of ReNu with SupraClens made their contact lenses feel clean, and over 98 percent felt that these products made lens care easier. Because compliance with a contact lens care regimen has often been linked to the ease of the regimen, combining SupraClens daily protein remover with ReNu MultiPurpose solution may promote better patient compliance, and it may ultimately furnish a more successful patient lens wearing experience.
The introduction of SupraClens, a daily-use liquid enzymatic cleaner that can be used simultaneously with lens storage and disinfection, is a valuable addition to lens care. This study provides evidence that its use can be extended beyond Opti-Free Express so that patients using ReNu MultiPurpose solution can also take advantage of its ease and efficacy in removing protein deposits.
This study was sponsored by Alcon Laboratories, Inc.
Dr. Watanabe is an assistant professor at the New England College of Optometry and the
director of contact lens services at the New England Eye Institute. He has lectured
internationally and is in part-time private practice in Boston, Mass.