EagleVision
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The many forms and causes of dry eye syndrome are targeted by a nearly equal number of devices to treat the malady.
Approximately 30 million Americans have some form of dry eye symptoms, and the companies that specialize in this problem know
that when patients seek relief from their doctors, those doctors must have the solution in hand.
Companies with energetic research and development programs are eager to help ophthalmologists treat their patients who suffer
from dry eye. When punctal plugs are indicated as the best temporary or long-term solution to the problem, there is no shortage
of routes an ophthalmologist can take.
Name says it allLamar Chandler, director of refractive products for CIBA Vision, Duluth, GA, said that, in the effort to deal with dry eye,
his company is pleased to be able to offer a product that has a name that so readily tells the ophthalmologist and the patient
what it does-TearSaver.
"TearSaver is such a great name," Chandler said. "It offers a brand identity that is readily known by a lot of doctors. However,
the product has much more than a name, it also has features such as a tapered shaft design that helps secure the plug in the
punctum."
Unique designs and advanced materials are what CIBA banks on to convince doctors that they cannot find a product more suited
to relieving dry eye.
CIBA Vision
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"These are products that doctors will find relieve symptoms and keep patients comfortable," Chandler said. "They have maximum
retention and minimum irritation."
CIBA's tapered shaft design offers a secure anchor in the punctum, meaning it is less likely the user will rub the product
out of position or completely out of the eye.
"The tapered shaft technology creates a downward vector force in the canaliculus whenever the user blinks, and that further
secures it," Chandler said. "This is a product that is ideal for post-LASIK dry eye."
TearSaver Punctum Plugs come two to a box and are available in 0.4, 0.5, 0.6, 0.7, and 0.8 mm.
The company also offers TearSaver plus, which is biocompatible. It has HEMA-PVP coating that provides protection for the
punctal tissue.
"That means these plugs are less irritating because of this state-of-the-art ocular surface protection," Chandler said. "It
is a straight-shaft plug."
CIBA's TearSaver Punctal Gauging System consists of two instruments with a gauge and dilation tip on each end, which makes
it easier to fit patients with punctum plugs.
"By inserting the gauge tip into the punctum until the punctal ring sits flush around the shaft, the ophthalmologist can easily
and accurately determine what size plug is right for the patient," Chandler said.
CIBA's temporary collagen inserts are designed to evaluate the effectiveness of punctal occlusion and enhance retention of
ocular medications. They are effective for 3 to 5 days and dissolve completely in 7 to 10 days.
Medennium
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Form follows functionForm following function is a key part of the success at EagleVision, Memphis, TN, a company founded by Jerre Freeman, a pioneer
in the development of punctal plugs.
Wade Allen, product manager at Eagle, said his company has improved on the tapered-shaft design that makes its products superior
to the competition. "Our Eagle Flexplug was created with the acknowledgment of the importance of form following function,"
Allen said. "It's the only tapered-shaft punctum plug with contouring traction ribs. This is the ultimate product in terms
of patient comfort, flexibility, and fixation."
The contour is also on the inside of the plug, which means greater flexibility.
"It gives the plug more surface area, which gives it more tissue area and thus more retention," Allen said.
Eagle's recognition of the special needs of older patients with more flaccid skin has brought it to offer the largest plug
in the business at 1.1 mm.
"We have found that more and more physicians are requesting the 1.1-mm plug," Allen said. "This is an example of our de-velopment
team reacting to the needs ofophthalmologists. We were receiving calls for a larger plug."
EagleVision plugs all have a super-thin rim so they actually sit concave in the punctal opening, not touching the eye. The
rim sits on top of the punctal opening and all plugs are opaque.
The regular Eagleplug is the original tapered-shaft punctum plug, according to Allen.
"It is easy to insert and remove," he said. "It's the economical dry eye solution with a proven record of success."
Lacrimedics
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EagleVision also has a Flow Controller, which physicians can use when total punctum occlusion would be too aggressive. Its
tapered shaft creates a vector force that keeps it snug, and it is easily monitored. Temporary Collagen Inserts from EagleVision
are dissolvable and can be used as a cost-effective way to evaluate the value of permanent punctal occlusion. The inserts
work for 3 to 5 days and dissolve in 7 to 10 days.
"We also have the Color Bar Schirmer Tear Test that makes dry eye diagnosis simple and consistent," Allen said. "The soft,
blue dye line clearly delineates the tear flow in a calibrated scale. That eliminates tedious measuring."
High comfort levelOne more product name that might have executives of some companies wondering why they did not think of it first is the SmartPlug,
which Medennium's Jay Standish said is excellent evidence of his company's innovation.
As vice president of sales and marketing, Standish said he is confident that his company offers ophthalmologists a product
to defeat dry eye that has a comfort level much higher than can be attained by any product offered by other companies.
"We have received testimonials from many doctors who say that their patients are very satisfied with the SmartPlug because
there is just no sense of a foreign body being present in the eye," Standish said. "When doctors discover the SmartPlug, they
pretty much start using it exclusively."
Standish said Medennium, Irvine, CA, is an emerging leader in ophthalmic materials and devices. He said its research and production
facility is designed to create one of the most sophisticated environments in the world for ophthalmic technology.
"We are ready to advance eye care around the world," Standish said.
Oasis
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The product's full name is the Smart Punctum Plug, and it is made from a unique thermodynamic acrylic polymer that is a thin,
rigid rod when removed from the package. Seconds after insertion, it transforms into a soft, gel-like plug that conforms to
the patient's punctum.
Standish said ophthalmologists who have tried the SmartPlug have found that its room-temperature rigidity makes it easier
to insert, and that the flexibility gives comfortable, stable positioning in the punctum shape, which is pleasing for the
patient and, of course, functional.
Standish said Medennium's goal is to develop and introduce innovative ophthalmic products to be made from patented polymer
materials developed by the company.
"The SmartPlug is ingeniously designed to create a size that fits every eye," Standish said. "The one-size-fits-all design
conforms to the patient's punctum shape and size after insertion."
Nothing sticks up above the punctum with the SmartPlug, which is 0.4 mm prior to insertion.
"The unique feel of the SmartPlug makes it perfect for dry eye therapy," Standish said. "The company strongly feels this product
really makes other therapy choices obsolete, so we expect to be the market leader."
Pioneer in plugsAnother company that is part of the original pioneering process in punctal plugs is Lacrimedics, Eastsound, WA.
The father of the current company president-Robert Herrick-had a hand in inventing the Herrick Lacrimal Plug in 1990.
Lacrimedics saw drawbacks with the surface plug, and that brought about development of the intracanalicular-type plug.
"Obviously our company had foresight in embracing intracanalicular occlusive devices, because other companies are coming around
to this type of dry eye treatment," Herrick said.
Odyssey
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Lacrimedics also developed opaque plugs in 2000, which Herrick said aid the doctor in positioning the plug and in post-insertion
management of the product.
The company offers the Lacrimal Efficiency Test with collagen plugs, which dissolve in 4 to 7 days, providing temporary lacrimal
occlusion through partial blockage of the horizontal canaliculus.
"With this product the ophthalmologist can determine the potential effectiveness of long-term lacrimal occlusion, and it is
effective in the diagnosis and short-term treatment of dry eye-related contact lens problems," Herrick said. "It also enhances
the efficacy of ocular medications and after surgery can prevent complications due to dry eye."
Lacrimedics' collagen plugs will not fall out of the punctum after proper placement, and patients should have little or no
discomfort from the plug. The plug should not touch the eye at any time.
Non-dissolvable Herrick Lacrimal Plugs provide long-term occlusion through partial blockage of the horizontal canaliculus.
"This product is easily inserted through the vertical canaliculus into the horizontal canaliculus," Herrick said. "Dilation
is usually not required for insertion."
The Herrick Lacrimal Plug is available in 0.3-, 0.5-, and 0.7-mm shaft diameters. The collapsible bell on each plug is 0.85,
1.4, and 1.95 mm, respectively. The plugs can be removed by pressure saline irrigation or probing.
The latest offering from Lacrimedics is the Williams intracanalicular plug positioning tool, or "Wippt," developed this year
by Dr. Paul Williams.
Surgical Specialties
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"When a physician uses this probe for positioning, the patient will have a ready response about the feel of the plug's positioning,"
Herrick said. "The patient can thus help the ophthalmologist find the right position for the plug.
"The most important thing we do at Lacrimedics is equip the doctor," Herrick said. "First and foremost we are trying to provide
service for ophthalmologists."
Innovative productsOasis Medical, Glendora, CA, manufactures and delivers innovative products as solutions to dry eye, said Donnas Ryskey, marketing
administrator for the company. She said Oasis always meets the highest possible levels of quality and reliability.
Oasis recently won FDA approval for its Soft Plug Extended Duration absorbable plug. Ryskey said the product won approval
for use in Europe in February 2001.
The Extended Duration Plug, which lasts up to 3 months, was designed to provide comfort for patients suffering from post-surgical
dry eye. The plug is available in 0.4 and 0.5 mm.
"This saves the patient the cost of a silicone plug and they don't have to keep putting in eye drops," Ryskey said. "We're
calling this the $6 plug. It's an efficient and economical treatment for intermediate dry eye indications. We are the only
ones on the market with anything similar to this plug."
Oasis has a permanent, but removable, silicone plug that is made of a softer silicone than that used by some of Oasis' competitors.
"With our permanent silicone plug, there is no foreign-body sensation for the patient," Ryskey said. "It is made of a clear
material, but it can easily be seen by the doctor, while at the same time it does not stand out."
The plugs are pre-loaded on individual inserters and are individually packaged.
"Oasis was the first company to have a one-at-a-time dispensable punctum plug," Ryskey said. The product comes in five sizes.
Alcon
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Oasis also offers a collagen plug. It is a diagnostic, dissolvable plug that will help ophthalmologists efficiently and reliably
determine whether putting in a more permanent punctum plug will be beneficial to the patient. It is also intracanalicular.
"Our products are among the best available on the market in helping ophthalmologists help their patients overcome dry eye
problems," Ryskey said. "Oasis was founded in 1987 to develop products for the cataract market, and in the past 8 years we
have expanded our ophthalmic offerings to include products for both the dry eye and refractive markets. We continue to evaluate
other markets that can be developed using our technology."
Oasis has distributors for its products in more than 40 countries.
"We are the only company with such a versatile lineup of punctum plug products," Ryskey said.
Precise fitOdyssey Medical, Memphis, TN, is dedicated to the development, production, and distribution of high-quality punctal occluders
that are used throughout the world by eye-care professionals for the treatment of dry eye, explained Barbara Tatge, vice president
of marketing at the company.
The company's Parasol Punctal Occluder features a patented design for simpler insertion and removal, and for a more precise
customized fit. Ophthalmologists using this product are also supplied with a precision manufactured surgical-grade disposable
inserter.
Tatge said there are several important advantages for the doctor and the patient with the Parasol: it is easy to insert, easy
to fit, easy to remove, has simple sizing, and has better retention.
Upon contact with the punctal ring, the Parasol Punctal Occluder will automatically collapse, reducing its size more than
50% for simpler insertion with minimal trauma. Odyssey says that ophthalmologists may find that dilation of the punctum is
unnecessary.
FCI
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Once inserted, the Parasol "opens" like a parasol to conform to the size of the canaliculus. The result is a precise, almost
customized fit that resists accidental removal. Odyssey says the virtually invisible dome of the Parasol provides a very efficient
lacrimal barrier.
Removal of the plug can be accomplished, if necessary, by applying a constant, gentle, lifting force beneath the dome. The
soft-as-tissue parasol will reverse and slide out smoothly.
Tatge said the product is available in three sizes, but two of those sizes (small and medium) fit virtually all patients.
Odyssey also says the fact that it has only three sizes of the Parasol assures the ophthalmologist that he or she always has
the right one available, and thus inventory costs are reduced.
Because the Parasol is specifically designed for excellent retention, Odyssey is backing it with a no-nonsense pop-out guarantee.
If a patient loses the Parasol plug within 30 days of insertion, Odyssey will replace it at no charge.
Odyssey also markets dissolvable collagen inserts that allow comfortable, cost-effective punctal occlusion. This product comes
in 0.2, 0.3, and 0.4 mm and can be used to predict the potential effectiveness of long-term punctal occlusion using the Parasol.
The product can be used as a diagnostic aid for dry eye syndrome and to reduce the drying effects of refractive surgery.
Wide range of sizesDavid Brown, director of marketing, ophthalmic products at Surgical Specialties Corp., Reading, PA, said his company continues
to make improvements in its punctal plug line with the introduction of products and systems that offer physicians the strongest
tools for treating dry eye.
He said that for 30 years the company has provided physicians with innovative products of the highest quality, and that quality
is a continuing part of Surgical Specialties' punctal plug line. The proof is in the UltraPlug.
"The UltraPlug is a product that is preferred by many physicians and is comfortable for their patients," Brown said. "Our
success is built on the success of our customers-understanding their needs and developing products that enhance their clinical
outcomes."
UltraPlug silicone punctum plugs are designed for insertion into the punctal opening, blocking tear drainage through the canaliculus.
Each plug is fabricated from soft, medical-grade silicone and comes pre-loaded in a convenient disposable dispenser. Brown
said the UltraPlug is engineered to have greater retention in the punctum and greater comfort for the patient.
The silicone plugs at Surgical Specialties come in 0.4, 0.5, 0.6, 0.7, and 0.8 mm, while its collagen line is available at
0.2, 0.3, and 0.4 mm. The silicone plugs are supplied two to a box. Brown said the company offers competitive pricing.
The wide range of sizes for the plugs is an important consideration for Surgical Specialties. Brown said the company wants
to be able to provide physicians with the options they need in treating dry eye, and that includes size variety for the very
best product.
"The UltraPlug is shaped to enhance the ease with which the physician inserts it into the punctum," Brown said. "In addition
to the patient comfort level, the plugs are clear in appearance and not easily visible to the patient."
Surgical Specialties recently received 510(k) approval for its UltraPlug synthetic absorbable punctal plug. The company says
the punctal plug is ideal for post-LASIK patients exhibiting dry eye symptoms and plans to introduce it during the American
Academy of Ophthalmology annual meeting next month.
The company also offers a dry eye management kit to practices that may want to promote themselves as dry eye specialists.
The kit includes an assortment of plug sizes, tests for dry eye, and marketing materials.
Brown said that with the variety, intensity, and length of time that symptoms relative to dry eye can bother the patient,
physicians can turn to Surgical Specialties with comfort and confidence for the best in treatment of dry eye.
Solving eye problemsWorking with leading ophthalmic surgeons has been a key to the success of FCI Ophthalmics, Marshfield Hills, MA, said Anne
Bohsack, a company spokesperson.
She said the company has been a world leader, since its inception in 1984, in products that solve eye problems.
FCI's unique slanted collarettes on its original model punctum plugs were designed to solve the problem of plugs popping out
prematurely.
"Our plugs have slightly larger bulbs than other plugs on the market, and this tends to keep the plugs in place better," Bohsack
said. "Our slanted-collar plugs, when placed properly with the high side of the slant pointing nasally, lie flush with the
eyelid margin and avoid patient rub-out. That's why we like to refer to them as 'anatomy friendly.' "
FCI plugs are made of soft, medical-grade silicone, are easy to insert, and can be removed with forceps. The collar prevents
migration into the canaliculus.
Bohsack said physicians are pleased to comment about the product once they try it and see the reaction of their patients.
Kent Keys, MD, of Anniston, AL, called the FCI plug his plug of choice. "I have found the FCI plug to stay in place well and
to be far more comfortable than any other I have used," he said. Robert Butryn, MD, of Traverse City, MI, said he uses FCI
plugs on patients with dry eye symptoms following LASIK to help the healing process.
FCI's "Ready-Set" Punctum Plugs are available in 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, and 1.0 mm. The plugs are packaged with two
pre-loaded, individually sterile plugs per box. Depending on volume purchased, they range between $20 and $30 per plug. FCI
has an introductory offer of $35 per box.
The company's Temporary Collagen Plugs come in 0.2, 0.3, and 0.4 mm. They are also packaged in a variety pack and are all
2.0 mm in length. They are 72 pieces per box at $60 per box.
FCI also has PVP Perforated Plugs that are coated with a thin layer of polyvinylpyrrolidone that makes the surface as slick
as glass to enhance drainage and to prevent debris from collecting on its surface. They are two per box at $84 per box.
Products by stagesComfort by design is the working description of the Tears Naturale Punctal Plugs offered by Alcon Laboratories, Fort Worth,
TX.
Kim Marek, senior product manager-consumer products marketing, said Alcon offers its dry eye products in stages that help
the ophthalmologist determine if punctal plugs are the right step for patients with dry eye.
First is lubricant eye drops that include Tears Naturale Forte Lubricant Eye Drops and Tears Naturale FREE Lubricant Eye Drops
for patients sensitive to preservatives. The next stage is collagen plugs, which test the effectiveness of occlusion. The
physician monitors the patient's progress for 7 to 10 days until the collagen plug dissolves. The final stage is Tears Naturale
Silicone Punctal Plugs for comfortable long-term occlusion.
The Tears Naturale Punctal Plugs have softer low-durometer silicone for a more natural "skin-like feel," Marek said. "The
low-profile cap is designed for improved comfort and the reduction of lid sensation and plug awareness."
Clear silicone offers the patient less noticeability in the eye and greater cosmetic appeal. The plugs come with a precise,
pre-loaded inserter with accurate fingertip control to prevent premature plug insertion.
Alcon's Collagen Plugs have unique surgically smooth edges and shaft, which means easy, comfortable insertion, Marek said.
"Patients who need punctal occlusion want more than just dry eye relief," Marek said. "They also want their punctal plugs
to be as comfortable and as unobtrusive as possible. That is why Alcon punctal plugs are growing in popularity with eye-care
professionals and their patients everywhere."
