Opti-Free Express receives ‘no rub’ indication by FDA
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FORT WORTH, Texas The Food and Drug Administration (FDA) has given Opti-Free Express multipurpose solution (Alcon Laboratories) a no rub indication, making it the first multipurpose product to receive this designation. The clearance, which covers lenses worn for 30 days or less, means that the solution cleans and disinfects soft contact lenses without requiring digital rubbing.
The company has submitted additional data to the FDA requesting that the clearance be extended to all soft lenses, including nondisposables. Alcon launched Opti-Free Express, formulated with Aldox and Polyquad antimicrobial agents to disinfect and kill Pseudomonas and Acanthamoeba, last year.
Primary Care Optometry News interviewed three practitioners a year ago about multipurpose solutions and their efficacy. Now, the same three optometrists comment on the new FDA designation for Opti-Free Express.
Douglas Weberling, OD, who works in a solo practice in Bristol, Va., said the product provides peace of mind, particularly when dealing with noncompliant contact lens patients.
We must remind patients to rub their lenses, because they forget about that 10-second rub, he said. All patients do it for the first few weeks; then, they just throw the lenses in the solution and expect the solution to do the rest. So I am pleased with this, because simpler regimens make it more likely that patients will keep their lenses clean.
Dr. Weberling said that, while he will still suggest digital cleaning to his patients as a good habit, the urgency to do so is not there as it was in the past. I still believe that it doesnt hurt to spend that 10 seconds doing the digital cleaning, but its nice to know that if patients dont follow through, with this solution the lenses will still be better disinfected than they have been in the past, he said.
Manual rubbing provides extra comfort
More than just keeping the lenses disinfected, rubbing the lenses keeps them comfortable, said Peter Bergenske, OD, in group practice in Middleton, Wis. I think the data support that Opti-Free is effective as a disinfectant without the rub, which is a pretty significant accomplishment; on the other hand, I think its still wise to advise patients to do the rub and rinse steps, Dr. Bergenske said.
Previously, the steps were necessary because the disinfectants werent strong enough to accomplish disinfection without them, he continued. But rub and rinse is still significant in terms of just comfort the lenses will be cleaner. The fact that Opti-Free is approved as a stand-alone disinfectant is a great accomplishment, and it gives us a margin of safety where you have relatively noncompliant patients. But I think for most patients to be optimally comfortable, they will benefit by doing the rub step.
That step has two purposes: to get debris off the lenses and to decrease the microbiological load that goes into the disinfectant, Dr. Bergenske continued. They are closely related; one has to do with contamination, and the other has to do with normal comfort. Not all patients are going to experience discomfort if they dont rub. Some patients will be able to simply take the lenses out, put them in the solution and get the 2 or 3 weeks out of their lenses that they expect. But some patients will find they get a slightly shorter lens life because theyre not rubbing them.
Waiting for more data
While the FDA indication is a significant breakthrough in the area of multipurpose solutions, some practitioners are remaining cautious before recommending the product as a no-rub solution to patients. Maybe there is something to it, but I'd like to see some of Alcons data on it, said Chuck Aldridge, OD, FAAO, in solo practice in Burnsville, N.C. I wouldnt feel comfortable recommending this as a no-rub solution yet, not until the jury gets back in on this. With all due respect, I dont consider the FDA to be the jury. Its main goal is to prove that a solution is safe. Effectiveness is not necessarily its goal as long as certain microbial organisms are killed. I want to know how effective it is and whether or not it is as effective as digital rubbing.
Because the solution is recommended for lenses worn 30 days or less, Dr. Aldridge noted that lenses replaced on such a short schedule would most likely not accumulate an extreme amount of surface deposits anyway. But practitioners should exercise caution with conventional lenses, he said. Call me old-fashioned, but I dont want patients and physicians to get confused and start using it on conventional soft lenses, he said.
Practitioners can immediately begin dispensing their Opti-Free Express lens care kits to patients and inform them of the no-rub indication until new kits with new labeling and directions arrive, said Sue Faro, marketing manager for Lens Care at Alcon. The company planned to mail dispensing pads with the new no-rub instructions to eye care professionals in September. Patient directions can also be downloaded from the Opti-Free or Alcon Web sites, said Ms. Faro.
For Your Information:
- Douglas Weberling, OD, is in is in private practice. He may be reached at 1701 Euclid Ave., Bristol, VA 24201; (540) 466-4227; fax: (540) 466-3937.
- Peter Bergenske, OD, is in group practice at Isthmus Eyecare. He may be reached at 8313 Greenway Blvd., Middleton, WI 53562; (608) 836-0678; fax: (608) 836-0858.
- Chuck Aldridge, OD, FAAO, may be reached at PO Box 218, Burnsville, NC 28714; (828) 682-2104; fax: (828) 682-4217.
- Neither Dr. Weberling, Dr. Bergenske, nor Dr. Aldridge has a direct financial interest in the products mentioned in this article, nor is any a paid consultant for any companies mentioned.
- Sue Faro is marketing manager for Lens Care at Alcon Laboratories, 6201 South Fwy., Fort Worth, TX 76134-2099.
- Opti-Free Express is available from Alcon Laboratories, 6201 South Fwy., Fort Worth, TX 76134-2099; (817) 293-0450; Web site: www.opti-free.com.