Dry Eye Institute

Anno Domini: 1983 -

Accomplishments by Calendar Year:

Year 1983:

Frank J. Holly, Ph.D., a tenured professor of Ophthalmology and Biochemistry at the Texas Tech University Health Sciences Center was requested by the National Eye Institute, National Institute of Health to organize a meeting of national scope on the physiology and pathophysiology of the human tear film. Due to lack of support within the department he founded the Dry Eye Institute to have a basis for obtaining financial support for organizing the meeting. This is why and how the Dry Eye Institute was born.

Year of 1984:

Organization of the First International Tear Film Symposium held in Lubbock, TX in November, 1984. The meeting was an unexpected success. Enthusiastic researchers familiar with Dr. Holly's pioneering research in this field during the seventies came from fourteen countries to participate in this symposium. Professor Murube del Castillo from Spain, the foreign guest of honor initiated the founding of The International Society of Dakryology at this time. Professor Holly was asked to serve as the first president.

Year of 1985:

Organization of a Lacrimal Workshop [Frontiers in Lacrimal Research, No. 1] in Sparks, NV in June 1985.

Lecture tour by Professor Holly visiting seventeen universities in England, Spain, Switzerland, The Netherlands, West Germany, Hungary, Denmark, and Sweden responding to invitations by the respective ophthalmology departments.

Year of 1986:

The proceedings of the Tear Film Symposium held in 1984 constituted the basis for a lacrimal research reference book (hard-bound, over 1,000 pages with color plates) that was published by the Institute in 1986.

Professor Holly was invited to a lecture tour in under the sponsorship of Bausch and Lomb to Japan and Korea. He lectured to physicians and medical students in several universities in Tokyo, Osaka, and other Japanese cities which were simultaneously translated to Japanese. He also lectured to faculty in English only. At the same locations.

Year of 1987:

In conjunction with the International Society of Dakryology and the Hungarian Society of Ophthalmology, the Institute organized an international meeting in Budapest, Hungary in 1987 with representatives from 23 (including Eastern Block countries) countries participating.

Under the aegis of Vision R&D Laboratory, Dr. Holly and his research team completed the formulation and testing of two novel artificial tears, called Dwelle® and Dakrina®. They were introduced to the market by Dakryon Pharmaceuticals, a sole proprietorship.

Year of 1988:

A survey of the diagnostic and treatment modalities currently employed by ophthalmologists and optometrists was conducted by the Institute in 1988. The findings were presented by Professor Holly in Amsterdam, the Netherlands in September, 1988 as an opening lecture of a dry eye symposium and has been published in the June issue of the Contact Lens Spectrum of the following year.

Dr. Holly and his team of co-workers completed the formulation and testing of an additional artificial tear, the so-called NutraTear®.

Year of 1989:

Organization of a Southwest Regional Meeting in August, 1989 for eye care professionals from Texas, parts of New Mexico, Colorado, Kansas, Oklahoma, and Arkansas (the meeting was canceled due to an insufficient number of registrants).

The Institute donated several of its published book on the tear film to outstanding academic institutions where eye research is conducted such as the Nuffield Laboratory at Oxford University and the Eye Pathology Institute in Copenhagen, Denmark.

Organization of the upcoming second triennial meeting of the International Society of Dakryology in conjunction with the Netherlands Ophthalmological Institute.

Invitation and sponsorship of Dr. András Berta to spend a year at the Institute as a Visiting Professor of 1990. Dr. Berta, a recipient of the"Lacrima" Award of the Dry Eye Institute, was possibly one of the most outstanding tear enzyme expert in the world at that time and expressed a desire to work with Dr. Holly as early as 1984.

Professor Holly took and early retirement as a Professor of Ophthalmology and Biochemistry at Texas Tech University Health Sciences Center.

Year of 1990:

Participation in the Second Meeting of the International Society of Dakryology that was held in July 23-25 in Amsterdam, the Netherlands. The Dry Eye Institute donated 10 books of its published tear film treatise to the Netherlands Opthalmic Institute and offered as a gift the same book to any participant at the meeting who requested it. Dr. Holly's term as the elected president of the society ended and he was succeeded by Dr. N.J. van Haeringen of the Netherlands Opthalmic Institute. The newly elected secretary and the organizer of the next meeting of the society was Dr. Juan Murube del Castillo of Madrid, Spain. Dr. Holly has become the Advisor to the International Society of Dakryology.

Sponsorship of a year-long research project conducted by visiting scholar Dr. András Berta on the role and control of the three tier enzyme system in the tears from the Debrecen Medical School in Hungary.

Dr. Frank J. Holly was the invited foreign speaker at the Dry Eye Symposium, organized by the La Fundación Oftalmologica Nacional in Bogotá , Colombia in May 31-June 2. Dr. Holly delivered a total of five lectures at this well-attended, important Colombian meeting.

Juan Carlos Suarez, M.D., the recipient of a Fulbright scholarship from Montevideo, Uruguay visited the Dry Eye Institute in September and worked on the research plan for his upcoming stay at the Dry Eye Institute in 1991.

Year 1991:

Completion of the research project of Professor Berta on the role and control of the tear enzyme cascade system in the human eyes. Several publications resulted from that work. The Institute also continued research of the rheology of the tear film system with Thomas F. Holly. The grant application on the enzyme project was approved by the National Eye Institute, but later not funded. Thus all the expenses of the year long visit of Dr. Berta and family were underwritten by the Dry Eye Institute. A sizeable donation by Dr. Holly to the Institute took care of the unexpected expense. (It should be perhaps noted here for posterity that during an IRS audit of Dr. Holly two years later this donation was not allowed as a deduction to a nonprofit organization as it exceeded 50% of Dr. Holly's income for that year.)

Year 1992:

Juan Carlos Suarez, M.D. received a Fulbright scholarship from Montevideo, Uruguay and attempted to spend a year at the Dry Eye Institute. His visit was canceled at the last minute when the Fulbright scholarship was withdrawn from him. The scholarship was re-offered to him, but only if he would only spend his time in the School of Optometry, University of Alabama at Birmingham. Dr. Suarez did not want to go to Birmingham, and the School of Optometry had no project of interest for him. The School would have only accepted him (i.e. the funds) if Dr. Suarez had only spend a token time there but would spend the rest of the time "sub rosa" at the Dry Eye Institute. Dr. Holly declined this "deal" for being not quite above board and being disadvantageous to the integrity of the Dry Eye Institute.

Year 1993:

Dr. Holly was the guest of honor at the Third Triennial meeting of the International Society of Dakryology in June, 1993 as a guest of the Spanish Government. At the triennial meeting of ISD held in Madrid, Spain in 1993, Dr. Holly's contribution to lacrimology was recognized and he was given the prestigious "Lacrima" Award along with two Italian lacrimologists. The Dry Eye Institute donated 100 books of its published tear film treatise to Professor Juan Murube del Castillo, University of Madrid, in Madrid, Spain.

In November, 1993, Dr. Holly was invited to an International Meeting on the Tear Gland, Tear Film, and Dry Eye Syndromes held in the Bahamas, as the after dinner speaker. He also contributed two papers "Advances in Ocular Tribology", co-authored with Tom Holly and "Lacrimation Kinetics as Determined by a Schirmer-type Technique". Both of these reported on research work that made significant contribution to lacrimology.

In the same year, an important review paper on the "Diagnostic methods and treatment modalities of dry eye conditions" by Dr. Holly was published in the International Ophthalmology, by Kluwer Academic Publishers, The Netherlands.

The FDA objected to the labeling of the ophthalmic eye drops formulated by Dr. Holly and co-workers because these drops did not fully comply with the Federal Guidelines established in a monograph in 1974. Dr. Holly prepared a Petition to the FDA in which he requested certain changes in the FDA guidelines for ophthalmic demulcents and scientifically justified the rationale for such changes showing that they would benefit dry eye patients.

Year 1994:

The Food and Drug Administration rejected the Petition of Dr. Holly aimed at revising the Federal Guidelines for ophthalmic demulcents. Since the guidelines were established twenty years before to lessen the regulatory work-load for the agency, its decision is perhaps understandable from the overworked FDA's point of view. However, such guidelines compiled in a monograph also tended to make the marketing of improved of artificial tears almost impossible. Dry Eye Institute advised Dakryon to reformulate its highly efficacious but not compliant ophthalmic demulcents (artificial tears) to become compliant with Federal Guidelines provided that such changes can be made without losing clinical efficacy. Such an attempt has already been made for Dwelle® in the previous year and concurrent studies found no decrease in clinical efficacy.

Year 1995:

The Institute was instrumental in establishing a cooperative venture between Professor Emeritus Mogens S. Norn of Copenhagen, Denmark and Dakryon Pharmaceuticals. Dakryon finally managed to bring to the market the Lissamine Green vital dye to replace the irritating and toxic Rose Bengal vital stain. The dye had been previously approved by the FDA as a coloring agent for food and drugs. To avoid the the tremendous expense and time requirement of filing a new drug application for the unapproved use of the dye as a diagnostic tool, the product was sold as a "Lissamine Green-colored ophthalmic demulcent" in compliance with FDA guidelines for ophthalmic demulcents.

This year the Dry Eye Institute also appeared on the Internet advertising its own publication and distributing vital information on the still poorly known and often mishandled disease group known as ocular surface disease or dry eye states.

Year 1996:

Dr. Holly was invited to participate in a Continuing Education course in ophthalmology organized by the Research Institute of Castroviejo (held March 23-25) in Madrid, Spain. Dr. Holly gave a talk in Spanish entitled "El Papel de los polímeros en el tratamiento del ojo seco" (the role of polymers in the treatment of dry eye) followed by a round table discussion about the novel diagnostic methods and treatment modalities in the field of treating ocular surface disease.

At the fourth triennial meeting of the International Dacryological Society in Stockholm, Sweden, Dr. Holly was chosen as the first recipient of the "Lacrima in Patin" Award a fist-sized silver tear drop with the picture of the world continents and the letters ISD molded onto the surface. This award was created by Professor Juan Murube del Castillo, the eminent lacrimologist and ocular surgeon of Madrid, Spain.

Dr. Holly and his wife were invited to the semiannual meeting of the Thai Ophthalmological Society held in Bangkok November 28-29 where Dr. Holly gave a hour-long plenary lecture. During the following days Dr. Holly was invited to give courses at Chulalongkorn Teaching Hospital, Siriraj Hospital, and Ramathibordee Hospital, all of which lasted a minimum of 2 hours followed by numerous questions and comments from the audience.

Year 1997:

Dr. Holly participated in the Annual Meeting of The Society of the European Ophthalmologists (SOE97) held in early June in Budapest, Hungary as a section chairman and lecturer on the topic of "How to Improve Poor Contact Lens Tolerance?"

Year 1998:

Running out of its financial resources Dakryon Pharmaceuticals ceased to exist in the Fall. For the time being MEDCO Pharmaceuticals agreed to manufacture the drops as the demand for these drops among the seriously ill dry eye patients was high. Dakryon was housing the Dry Eye Institute in its own laboratory so the Institute temporarily had no roof over its head but continued to exist.

Year 1999:

The Fifth Triennial International Congress of the International Society of Dacryology was held in Jerusalem, Israel in November. Professor Shabtay Dikstein organized the congress. This was the first time that the president of the society, Dr. van Setten of Sweden was not present. The three keynote lectures were:

Meibomian Gland Disease: The manifestation, mysteries, measurement and management.

    -- by Anthony J. Bron, University of Oxford, Oxford, England.

Progress in understanding ocular surface disease: The past thirty-five years.

   -- by Frank J. Holly, Dry Eye Institute, Yantis, TX, USA

                                            and

From research to industry - the Yissum model

    -- by M. Perlmutter, Yissum, Jerusalem, Israel.

Dr. Holly also gave a talk on Common mistakes in the treatment of ocular surface disease, and co-authored a paper given by Jerry W. Cook, M.D. entitled: A novel method to assess tear film integrity in patients. The participants were from Austria, Bulgaria, China, England, France, Germany, Israel, Spain, Sweden, Switzerland, and the U.S.A.

Despite the enthusiastic audience and quality lectures and papers, there were signs that this highly academic, apolitical society may not have a promising future due to politics. Unfortunately, since the early nineties, the medical concensus in the United States and thus in many parts of the world has been regressing to outdated concepts both in the diagnosis and treatment of dry eye patients. The results of the pioneering research conducted in the seventies and eighties were never fully understood and failed to become integrated in the training of ophthalmologist and optometrists. The true losers are the dry eye patients.

Year 2000:

MEDCO Pharmaceuticals ceased to function. Thus, the Dakryon's eye drops are no longer manufactured despite continued demand of patients suffering from severe dry eye problems.

The Dry Eye Institute recognized that laser surgery, the most modern method of refractive surgery still has the potential to cause and exacerbate dry eye symptoms. This is unfortunate, since many patients undergo laser surgery because they are unable to wear contact lenses due to their lacrimal abnormalities. The results can occasionally be tragic.

Year 2001:

Dr. Holly had been interviewed by a reporter of the MORE (women's) magazine and the result was published in the May issue. Dr. Holly stated that, in his opinion, laser surgery in a dry eye patients is contraindicated.

Due to the apparent need of the neglected dry eye patients a decision was made to revive the functioning of the Dry Eye Institute if financially possible. A small office has already been built in Yantis, Texas and its refurbishing is underway. More important for the patients is the fact that steps are made to bring the Dakryon's eye drops to the market again as they appear to be still the most efficacious eye drops in existence for patients suffering from some form of ocular surface disease including post-surgical eye patients of refractive correction.

Early summer Aqueous Pharma has obtained the rights to the three proprietary eye drops, Dwelle®, Dakrina®, and NutraTear®, originally formulated (and reformulated) by Dr. Holly. The eye drops will be marketed possibly next year if suitable contract manufacturer can be found.

Year 2002:

Dr. Holly decided to join the Surgical Eyes, Inc. and to become active on its Bulletin board (www.surgicaleyes.org) with the resources of the Dry Eye Institute.  With the co-operation of the leadership and many motivated members as well as with that of Aqueous Pharma, an informal study of the iatrogenic dry eyes, its characteristics and management had started.  In addition of the three proprietary drops, a new, phospholipid-containing eye drops, code-named APL-105 (FRESHKOTE™) was formulated and tested in three clinical studies conducted by two ophthalmologists and an optometrist both in the U.S. and in Australia.  Results indicated that in iatrogenic as well as in other dry eyes, FRESHKOTE™ was at least as effective as Dakrina®.  These eye drops have been made by a compounding pharmacy and supplied to doctors and post-surgical patients.  The progress has been monitored by the Dry Eye Institute in patient volunteers, who regularly submitted progress reports.

The results indicated that the eye drops of Aqueous Pharma is especially suited to treat the iatrogenic dry eye which is usually concurrent with adversely affected corneal epithelium, microcystic edema, recurrent epithelial erosion,  and corneal ulceration.   These collyria appear to be more efficacious than hypo-osmotic or  hyperosmotic eye drops, gels or ointments in managing dry eye conditions both in patients suffering from the Dry Eye Syndrome or in patients with iatrogenic dry eyes.

Year 2003:

This year Dr. Holly was awarded the annual Harold Stein Lectureship to be delivered at the inaugural meeting of the  CLES in Orlando, FL  on January 23.  His lecture " The iatrogenic dry eye and its management"  was delivered within a two-hour mini-symposium  on the dry eye chaired by David W. Lamberts, MD.

Year 2004:

On March 27 of this year Dr. Holly self-diagnosed himself with Restless Leg Syndrome and started to become active on the Discussion Board \of the RLS Foundation.  In the remainder of the year he has posted 690 times sharing his experiences and research results with others.  He, with the help of others, ran a survey and presented the results at the National meeting of RLS Foundation under the title:  Life with RLS: from the Patients' Point of View  in Long Beach, CA in early November.   At present he is running a continuous survey on-line which will be periodically evaluated and a new survey started.

Dr. Holly presented a poster entitled: Basic Considerations in the Diagnosis and Treatment if Iatrogenic Dry Eye secondary to Laser Visual Correction at the 4th International Conference on the Lacrimal Gland, Tear Film, Ocular Surface and Dry Eye Syndromes, November 17-20, Fajardo, Puerto Rico. He was also requested to write an Editorial in the Spanish Archives of Ophthalmology comparing this meeting to the original Tear Film Symposium twenty years before.

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