LENS CARE STUDY

Silicone Hydrogel Satisfaction Related to Lens Care Products

A study examines different combinations of lens care solutions and silicone hydrogel lens materials

By Bill Reindel, OD, MS, Gary Orsborn, OD, MS, & Gerard Cairns, MCOptom, PhD

Dr. Reindel is director, Global Medical Affairs for Bausch & Lomb.

Dr. Orsborn is director, Global Medical Affairs for Bausch & Lomb.

Dr. Cairns is manager, Global Medical Affairs for Bausch & Lomb.

Silicone hydrogel lenses represent a significant advancement in contact lens material development, and their use has grown dramatically over the last several years. In the United States, silicone hydrogel materials account for more than 50 percent of soft spherical contact lens fits and refits, and this is expected to increase to 75 percent in the next two years (Nichols, 2009).

Notwithstanding the benefits of silicone hydrogel lens materials, symptoms associated with discomfort can be a cause of dissatisfaction among silicone hydrogel lens wearers. While contact lens care products have demonstrated successful performance with both traditional hydrogel and silicone hydrogel contact lenses over the years, there continues to be considerable attention paid to the performance of multipurpose solutions (MPSs) when used with silicone hydrogel lenses.

To investigate whether switching the MPS would make a difference in the performance reported by silicone hydrogel contact lens patients, an open-label, prospective, multicenter study in which successful silicone hydrogel contact lens users of Polyquad/Aldox-preserved MPSs Opti-Free Express and Opti-Free Replenish (both Alcon) were switched to the polyaminopropyl-biguanide-preserved MPS ReNu Fresh (formerly ReNu MultiPlus, Bausch & Lomb), rub regimen.

Study Design

Independent eye-care practitioners from 45 investigational sites enrolled patients. Institutional review board approval was obtained for the study, and patients signed an informed consent form. At the initial visit patients completed questionnaires to rate their experience with their habitual brand of lens care (Opti-Free Express or Opti-Free Replenish). Using a 10-point scale (10 being the highest), they rated several performance attributes including how clean the lens was upon application and removal, comfort on application, day-after-day comfort, end-of-day comfort, sharpness of vision, and elimination of dryness.

At the initial visit, practitioners completed a slit lamp evaluation using a five-point scale, looking for signs of possible solution intolerance such as corneal staining, limbal injection, bulbar injection, tarsal abnormalities, and infiltrates. Patients were then switched to the ReNu Fresh solution for two weeks. Following the two weeks, the patients completed the same questionnaire to rate the performance of the new solution, and practitioners once again performed slit lamp evaluations. A Paired Sample T Test was conducted to test for significance using a 95-percent confidence interval.

Patient Lens and Lens Care History

Patient questionnaires and slit lamp examinations were completed on 388 patients. Of these patients surveyed, 201 used Opti-Free Express and 187 used Opti-Free Replenish as their habitual Polyquad/Aldox-preserved solution. It should be noted that, even though rubbing is not required, 47.8 percent of the Opti-Free Express subjects reported at the initial visit that they rubbed their lenses as part of their daily lens care. For the Opti-Free Replenish subjects, 63.6 percent reported that they rubbed their lenses. The subject breakdown by manufacturer of silicone hydrogel lenses worn was: 82 Bausch & Lomb (balafilcon A), 87 CIBA Vision (36 lotrafilcon A and 51 lo-trafilcon B), and 219 Vistakon (120 galyfilcon A and 99 senofilcon A).

Comparing Patient Evaluations

Tables 1 and 2 show the comparative results from the patient evaluations of MPS product performance attributes. Specific performance attribute ratings for clean at end of day (7.26 for ReNu Fresh versus 6.78 for Opti-Free Express; 7.33 for ReNu Fresh versus 6.70 for Opti-Free Replenish) and comfort at end of day (7.28 for ReNu Fresh versus 6.74 for Opti-Free Express; 7.28 for ReNu Fresh versus 6.66 for Opti-Free Replenish) were significantly higher for ReNu Fresh (p<0.05) regardless of the patient's previous habitual brand (Opti-Free Express or Opti-Free Replenish).

There were no differences noted in the patient ratings of MPS for clean or comfort upon application, sharp vision, continuous comfort day after day, and eliminates dryness throughout the day.

When patient evaluations of MPS performance as related to contact lens manufacturer were analyzed, ReNu Fresh was rated significantly higher with the B&L contact lenses compared to Opti-Free Replenish for clean at end of day (7.65 for ReNu Fresh versus 6.21 for Opti-Free Replenish), comfort at end of day (7.70 for ReNu Fresh versus 6.24 for Opti-Free Replenish), continuous comfort day after day (8.12 for ReNu Fresh versus 7.14 for Opti-Free Replenish), and eliminates dryness throughout the day (7.53 for ReNu Fresh versus 6.57 for Opti-Free Replenish). The patient evaluations revealed no other significant differences in the rating of the MPSs when used with B&L silicone hydrogel contact lenses. For CIBA contact lenses, there were no significant differences in the patient ratings of MPS performance for any attributes. With Vistakon silicone hydrogel lens wearers, ReNu Fresh was rated higher for clean at end of day (7.12 for ReNu Fresh versus 6.44 for Opti-Free Express) and for comfort at end of day (7.15 for ReNu Fresh versus 6.45 for Opti-Free Express). There were no other significant differences in MPS ratings for Vistakon contact lens wearers.

Slit Lamp Findings

Tables 3 and 4 show slit lamp findings. Ratings of grade 2 (mild) or greater were 5.2 percent for ReNu Fresh versus 3.5 percent for Opti-Free Express and 5.1 percent for ReNu Fresh versus 5.9 percent for Opti-Free Replenish for staining; 3.0 percent for ReNu Fresh versus 5.3 percent for Opti-Free Express and 2.9 percent for ReNu Fresh versus 5.6 percent for Opti-Free Replenish for limbal injection; 5.7 percent for ReNu Fresh versus 7.5 percent for Opti-Free Express and 6.2 percent for ReNu Fresh versus 9.1 percent for Opti-Free Replenish for bulbar injection; and 4.0 percent for ReNu Fresh versus 6.0 percent for Opti-Free Express and 2.9 percent for ReNu Fresh versus 6.1 percent for Opti-Free Replenish for tarsal abnormalities.

There were no grade 2 or greater infiltrates for Opti-Free Express, Opti-Free Replenish, or ReNu Fresh. Tarsal abnormalities demonstrated a difference in the Opti-Free Replenish versus ReNu Fresh comparison; ReNu Fresh had significantly fewer findings (p<0.05).

When comparing slit lamp ratings of MPS performance by lens manufacturer, there were no significant differences in findings of grade 2 (mild) or greater related to solution intolerance except with CIBA lenses, for which there were fewer reports of bulbar injection and tarsal abnormalities with ReNu Fresh compared to the Polyquad/Aldox-preserved solutions.

Conclusions

Silicone hydrogel patients who previously used Polyquad/Aldox-preserved products and converted to ReNu Fresh rub regimen generally experienced greater end-of-day clean and comfort satisfaction, per their own evaluations, while maintaining equivalent ocular health findings. These results support the possibility that, for silicone hydrogel wearers using Polyquad/ Aldox-preserved products who report symptoms of discomfort, a switch to the polyaminopropyl-biguanide preserved multipurpose solution, ReNu Fresh solution rub regimen, could improve their comfort. CLS

For references, please visit www.clspectrum.com/references.asp and click on document #169.