December 2010




Lacrisert spells relief for some patients

by Maxine Lipner Senior EyeWorld Contributing Editor

Insert helps moderate to severe dry-eye patients to function

Lacrisert insert

Individual insert package

Placement of insert Source for all: Aton Pharma

For moderate to severe dry-eye patients, the Lacrisert (hydroxyproply cellulous insert, Aton Pharma, Lawrenceville, N.J.) can help to quell signs and symptoms of dry eye including burning, dryness, grittiness, stinging, and light sensitivity, according to Bruce H. Koffler, M.D., associate clinical professor, University of Kentucky, Lexington, Ky. Investigators led by Dr. Koffler reported in the May issue of Eye and Contact Lens that users of the insert showed significant improvement in quality of life and activities of daily living, as well as in other signs of dry-eye syndrome.

The once orphaned drug was initially manufactured by Merck (Whitehouse Station, N.J.) in the 1970s as a drug delivery system for pilocarpine. While it tended to release too much of the pilocarpine resulting in unpleasant side effects, it appeared to have value for dry-eye patients. "There was a group of dry-eye patients who this was used for that was quite dependent on this type of therapy and felt like without it, their quality of life was dramatically reduced," Dr. Koffler said. "They were a vocal enough group and there were enough ophthalmologists and optometrists using this device that they were able to push Merck to continue to use it." Aton Pharma eventually purchased the Lacrisert and brought it back specifically as a dry-eye agent. Subsequently, this study was launched to take a closer look at how it could help dry-eye patients.

Open-label trial

Included in the prospective, open-label trial were 520 mild to moderate dry-eye patients. "On day one the patients selected were given quality-of-life questionnaires," Dr. Koffler said. "They had an examination by the practitioner and they were instructed on how to use the Lacrisert." At the 4-week mark they were brought back into the offices where they were once again asked to fill out the questionnaire, and the ocular examination was repeated.

At this 1-month mark, investigators found significant improvement in many patients. "Tear film breakup (times) increased 19%, fluorescein staining decreased 26%, and Schirmer's testing showed increased wetting of 10%," Dr. Koffler said. He theorizes that the Lacrisert helps to improve the tear film. "When the Lacrisert dissolves we know that it increases the tear film layer, and by producing a thicker tear film layer in the vast majority of patients, it allows increased retention time of the tear film," Dr. Koffler said. "That's why it helps to increase the tear film breakup time and patients have a better tear film."

The biggest adverse event with the Lacrisert was blurred vision, which occurred in about 8% of patients. "A small percentage of patients will notice that and say, 'My reading vision is blurred,' or something to that effect," Dr. Koffler said. "Interestingly, when we looked at activities of daily living and at the questionnaires in terms of working with a computer, there is a statistically significant improvement, so in some situations patients think it is better."

Gaining clinical perspective

Dr. Koffler hopes that practitioners come away from the study with the understanding that this is a helpful new modality to utilize for their dry-eye patients. He sees it as a good thing for practitioners to try with little downside. "They're not going to hurt anyone by using this," he said. "I tell physicians that they're going to help about 70% of their patients, according to what I have found in my office." Incorporating this into a practice, however, can take a bit of time. "I use the analogy of a new contact lens patient who you have to show how to insert and remove the lens so that the patient is comfortable," Dr. Koffler said. "You need a little time to teach your staff how to do that."

Once patients are familiar with it, he stressed that this is not a hard device to use. "It was shown in one study done with rheumatoid arthritis patients that they were capable of managing the insertion of this device themselves," Dr. Koffler said. "I encourage my older patients by saying, 'You can do this because even patients with rheumatoid hands can do it.'"

Dr. Koffler recommends that practitioners who are considering incorporating the Lacrisert into their practice actually try the product on themselves to see how comfortable it is in the eye. He also offers a couple of pearls for patient use. "Make sure that the insert is placed deep into the cul-de-sacnot halfway in but way down into the cul-de-sac where it is supposed to be," he said. "We have had equal success putting this in at night as first thing in the morning, so be flexible in terms of time of day."

Overall, Dr. Koffler sees the Lacrisert as an excellent product for dry eye, but it might benefit from some modern tweaking. "I think that there can be improvements in the design of the product and improvements perhaps in inserters," he said. "There are a lot of practical things that can be done to make the product even better."

Editors' note: Dr. Koffler has financial interests with Aton Pharma (Lawrenceville, N.J.).

Contact information

Koffler: 859-263-4631,

Lacrisert spells relief for some patients Lacrisert spells relief for some patients
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