Valeant Ophthalmics
Experts Report Benefits in Dissatisfied Dry Eye Patients: Post-Surgical, Contact Lens Patients, Ointment Users
Bridgewater, NJ – March 12, 2012 – Recently four dry eye experts reviewed their clinical experience with the LACRISERT® hydroxypropyl cellulose ophthalmic insert, the preservative-free, once-daily, sustained release prescription insert indicated for moderate to severe dry eye. David A. Goldman, M.D. (Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, FL), William Trattler, M.D. (Center for Excellence in Eye Care, Miami, FL), Barry A. Schechter, M.D. (Florida Eye Microsurgical Institute) and Jack Schaeffer, O.D. (Schaeffer Eye Center) shared their insights with Valeant Ophthalmics, a Division of Valeant Pharmaceuticals North America LLC. (Note: The physician experts were compensated for their time, in compliance with government and industry guidelines.)
All four physicians serve populations with a significant incidence of dry eye. They provided insights regarding patient selection for LACRISERT® therapy, when to consider LACRISERT® therapy and how to explain the unique insert to patients and train them in its use. LACRISERT® is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.
The experts emphasized the need to move promptly to prescribe therapeutics and seek other solutions when dry eye patients are not satisfied. Dissatisfied dry eye patients are often in one or more of three different categories: patients dissatisfied with recovery from LASIK and cataract surgery due to post-surgical dry eye; patients dissatisfied with dry eye symptoms that interfere with wearing contact lenses, with the potential for lens discontinuation; and dry eye patients dissatisfied with using ointment and gel treatments, which some consider messy, uncomfortable and inconvenient.
“I think one of the biggest hurdles for physicians right now, taking care of patients with dry eye, is that many aren't going toward therapeutics right away,” explained Dr. Trattler. “Many doctors will continue to use just artificial tears and hope that will do the trick but for many of these patients, artificial tears are just not enough.”
Dr. Trattler continued, “We really need to go to the next level. We really have great treatment options and LACRISERT® is a very important therapy for patients with moderate to severe dry eye.”
“When patients need to use artificial tears more than 4 times a day, compliance drops precipitously,” said Dr. Schaeffer. “LACRISERT® provides these patients with continuous coverage all day.” In most patients, one LACRISERT® placed into each eye once daily is effective in providing all-day symptom relief. Some patients may require twice-daily use for optimal results.
Dissatisfied Dry Eye Patients: Post-Surgical
Studies have shown that ophthalmic surgery may exacerbate existing dry eye.1 Ocular surface complications have been observed in patients after cataract surgery such as superficial punctate keratitis, recurrent filamentary keratitis, conjunctivitis and infectious keratitis, persistent epithelial defects and corneal ulceration.
Corneal surgical procedures disrupt the normal organization of the corneal nerves, causing damage to the cornea, disruption of the blink reflex and resulting discomfort. Several other factors are also believed to impact the ocular surface environment during and after cataract surgery and are associated with postoperative dry eye, including topical anesthesia, eye drops containing preservatives and exposure to light from the operating microscope.1
LASIK can exacerbate preexisting DES or trigger more symptoms,2 with nearly one third of LASIK patients report reporting dry eye after surgery.3
Use of LACRISERT® has been shown to help patients with post-surgical dry eye or dry eye-related OSD: Patients with previous cataract surgery using LACRISERT® had a 29.2% decrease in dry eye severity as determined by mean OSDI scores, and significant symptom improvement. Patients with previous LASIK surgery using LACRISERT® experienced significant improvement in key symptoms of dry eye.2 The dry eye experts reported success treating post-surgical patients with LACRISERT® as adjunctive therapy.
“For patients who have had cataract surgery or refractive surgery where the lateral nerves are cut in the cornea at the 3 and 9 o'clock positions, LACRISERT® can be very beneficial in helping to stabilize their tear film and in reducing punctate keratopathy,” explained Dr. Schechter.
“Patients who have a neurotrophic cornea, for instance after cataract surgery, after LASIK surgery, they also are not producing enough aqueous tear,” added Dr. Goldman. “I have found that LACRISERT® is very successful in giving them resolution of their symptoms.”
“Patients who have had cataract surgery sometimes can experience discomfort and irritation during the postoperative period and their vision may not be satisfactory,” continued Dr. Trattler. “If artificial tears and first line treatment are not adequate, LACRISERT® can be added as an adjunctive treatment. It has been very effective for the LASIK patient with dry eyes afterwards.”
Dissatisfied Patients: Contact Lens Patients with Dry Eye
“Most dry eye contact lens patients have to reduce their wearing time due to end of day discomfort,” explained Dr. Schaeffer. Dry eye has been shown to be the most common reason for contact lens intolerance and discontinuation.4
Dr. Schaeffer continued, “In many instances, use of LACRISERT® may help the patient to remain in contact lenses because of the reduction of the dry eye response. LACRISERT® keeps them comfortable and extends the patient’s wear time.”
In clinical studies, patients using LACRISERT® for one month experienced reductions in six key symptoms of dry eye (discomfort, burning, dryness, grittiness, stinging and light sensitivity) and improvements in activities of daily living such as using a computer or ATM.2
The following adverse reactions have been reported, but were in most instances, mild and temporary: transient blurring of vision, ocular discomfort or irritation, matting or stickiness of eyelashes, photophobia, hypersensitivity, eyelid edema, and hyperemia.
Dissatisfied Patients: Ointment Users
Another dissatisfied patient group the experts recommended as candidates for LACRISERT® therapy are dry eye patients dissatisfied with using ointment and gel treatments, which some consider messy, uncomfortable and inconveniently limited to nighttime use.
“I have had some patients who have been on nighttime ointments for dry eye,” continued Dr. Trattler. “These are typically patients who have moderate dry eye or more who need lubrication especially at nighttime. I have found these are the perfect patients to try LACRISERT® because the insert is easy to use and it doesn’t blur the vision to the same extent as ointments.”
Additional candidates for LACRISERT® therapy discussed by the dry eye experts include patients with abnormal Schirmer's test results, those with incomplete dry eye symptom resolution and frequent artificial tear users.
David A. Goldman reported, “Because LACRISERT® is allowing more of an aqueous component of the tear film to be supplied, really it is best suited for those people who are aqueous tear deficient, such as patients that come in with a Schirmer's test that is abnormal.”
“These patients will often have some symptoms,” agreed Dr. Trattler. “They will often have signs of the cornea and some corneal staining, and they often will either have morning or evening complaints of dry eye symptoms.”
“LACRISERT® is very beneficial for patients who have not had complete resolution of their symptoms when utilizing their normal artificial tears or other treatments,” Dr. Schechter added.
Algorithm: Considerations for Addressing Dissatisfied Dry Eye Patients
The attached algorithm presents a model for addressing three categories of dissatisfied dry eye patients who may benefit from LACRISERT® therapy: patients dissatisfied with recovery from LASIK and cataract surgery due to post-surgical dry eye1-3; patients dissatisfied with dry eye symptoms that interfere with wearing contact lenses4; and dry eye patients dissatisfied with using ointment and gel treatments.
Patient Training
Dry eye experts Dr. Goldman, Trattler and Schechter emphasized that patient orientation and training are essential for a unique insert like LACRISERT®. All reported that after adequate training, most patients, even older or impaired patients, are able to self-administer the insert easily.5
“The way I explain the medication to my patients is very simple: It is like using an artificial tear,” reported Dr. Goldman. “It is about the size of a drop of artificial tear but it actually slowly releases artificial tears so you don’t have to worry about using artificial tears as often throughout the day.”
Dr. Trattler continued, “I explain to the patients that this is a very simple treatment. I basically have my technicians spend a few minutes showing how to open up the package and place the LACRISERT® into the eye, and that is it. Just a few minutes of instructions and then the patient can be very successful with this technology.” All of the experts stressed the need to be hands-on when training patients to use LACRISERT®. In addition, patients should be provided with Patient Instructions for Use.
“In order to facilitate patient compliance with LACRISERT®, I often will spend a few minutes discussing the insert with them,” said Dr. Schechter. “I then have a technician spend some time placing the insert, making sure the patient feels adequately comfortable with the insert before leaving the office. In addition, we often have the patient place the insert on their own, to ensure that they are doing it correctly.”
Important Safety Information About LACRISERT®
LACRISERT® is indicated in patients with moderate to severe Dry Eye Syndromes, including keratoconjunctivitis sicca. LACRISERT® is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions. LACRISERT® is also indicated for patients with exposure keratitis, decreased corneal sensitivity and recurrent corneal erosions.
LACRISERT® is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose. Instructions for inserting and removing LACRISERT® should be carefully followed. If improperly placed, LACRISERT® may result in corneal abrasion. Because LACRISERT® may cause transient blurred vision, patients should be instructed to exercise caution when driving or operating machinery. Patients should be cautioned against rubbing the eye(s) containing LACRISERT®.
The most commonly reported adverse events were transient blurring of vision, ocular discomfort or irritation, matting or stickiness of eyelashes, photophobia, hypersensitivity, eyelid edema, and hyperemia.
References:
1. Cho YK, Kim MS. Dry eye after cataract surgery and associated intraoperative risk factors, Ko Jrl of Ophthalmol. 2009;23:65-73.
2. Luchs J, Nelinson DS, Macy J. Efficacy of hydroxypropyl cellulose ophthalmic inserts (LACRISERT) in subsets of patients with dry eye syndrome: findings from a patient registry. Cornea. 2010;29:1417–1427.
3. Jabbur et al, Survey of complications and recommendations for management in dissatisfied patients seeking a consultation after refractive surgery, J Cataract Refract Surg 2004; 30:1867–1874.
4. Nichols JJ, Sinnott LT. Tear Film, Contact Lens, and patient-related factors associated with contact lens-related dry eye. Invest Ophthalmol Vis Sci. 2006;47(4):1319-28.
5. Hill JC. Slow-release artificial tear inserts in the treatment of dry eyes in patients with rheumatoid arthritis. Br J Opthalmol 1989;73(2):151-4.