Dry Eye Syndrome: Clinical Trial Tracker

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    April 2014

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With nearly 300 million dry eye sufferers worldwide, dry eye represents one of the largest ophthalmic indications. It is also known as keratoconjunctivitis sicca. To date, there is no cure for dry eye syndrome, but there are treatments to control its symptoms. The prevalence of dry eye syndrome primarily increases with age, and has an estimated incidence of 15% in persons over the age of 65 years. A greater risk of acquiring dry eye is also experienced by females, with postmenopausal women being particularly at risk.

In the US alone, the economic burden of dry eye totals USD 3.84 billion in direct annual health care costs. After including the indirect costs of lost productivity, the societal burden of dry eye rises to USD 55.4 billion annually in the US. For patients, the average annual direct cost ranges from USD 678 for patients with mild dry eye to USD 1,267 for severe cases. If pharmaceuticals and punctual plugs are included, the cost for these patients rises to USD 2,959 annually. Furthermore, dry eye increases lost productivity through both absenteeism and decreased presenteeism, with the former ranging from 8.4 to 14.2 days per year depending on severity and the latter ranging from 91 to 128.2 days per year depending on severity.


Scope of the Report

The primary objective of this report is to capture details on the various clinical and preclinical trials which are currently underway in the field of dry eye. We have identified a number of such trials which are taking place across multiple geographies. For each specific trial, we have provided the following information:

  1. Trial Objective
  2. Manufacturer / Licensee
  3. Treatment Target
  4. Mechanism of Action
  5. Sponsor / Collaborator
  6. Trial Phase
  7. Trial Status
  8. Start Date
  9. End Date
  10. Enrolment
  11. Age Group
  12. Inclusion Criteria
  13. Exclusion Criteria
  14. Study Design
  15. Primary Endpoint
  16. Secondary Endpoint
  17. Treatment Arms
  18. Route of Administration
  19. Location(s)
  20. Trial Results (if known)

The above information has also been presented in the form of a dashboard to provide a high level quick overview of the ongoing activity in this space.


Section 1: Market Overview
Section 2: Dashboard: Pipeline Analysis
Section 3: Molecules in Clinical Development: Trial Details
Section 4: Molecules in Preclinical Development: Trial Details
Section 5: Excluded Drugs
Section 6: Inclusion / Exclusion Criteria

List of Figures

Figure 1: Molecules in Clinical Development: Distribution by Companies
Figure 2: Molecules in Clinical Development: Distribution by Highest Phase of Development
Figure 3: Molecules in Clinical Development: Distribution by Treatment Target
Figure 4: Clinical Trials: Distribution by Trial Phase and Status (Matrix View)
Figure 5: Clinical Trials: Distribution by Trial Status
Figure 6: Clinical Trials: Distribution by Trial Phase
Figure 7: Clinical Trials: Distribution by Route of Administration
Figure 8: Clinical Trials: Distribution by Sponsor Type
Figure 9: Clinical Trials: Distribution by Region
Figure 10A: Clinical Trials: Distribution by Molecules and Regions (Matrix View) – Set 1
Figure 10B: Clinical Trials: Distribution by Molecules and Regions (Matrix View) – Set 2
Figure 10C: Clinical Trials: Distribution by Molecules and Regions (Matrix View) – Set 3
Figure 11: Clinical Trials: Distribution by G7 Countries
Figure 12: Clinical Trials: Distribution by EU5 Countries


List of Tables

Table 1: Molecules in Clinical Development: Pipeline Details
Table 2: Molecules in Preclinical Development: Pipeline Details

Listed Companies

The following companies and organisations have been mentioned in the report:

  1. Acucela
  2. Alacrity Biosciences
  3. Alcon Research
  4. Allergan
  5. Amgen
  6. Astellas Pharma
  7. Azienda Ospedaliera S. Maria della Misericordia
  8. Bausch & Lomb
  9. Bristol Eye Hospital
  10. Bristol-Myers Squibb
  11. BTO Pharm Co Ltd
  12. C.T. Development America, Inc.
  13. Can-Fite BioPharma
  14. Chulalongkorn University
  15. Cross Research S.A.
  16. Daiichi Pharmaceuticals
  17. Denver Arthritis Clinic
  18. DH Bio Co., Ltd.
  19. Dompe S.p.A
  20. Dong-A Pharmaceutical Co., Ltd.
  21. Ehime University
  22. Eisai Inc.
  23. Eleven Biotherapeutics
  24. ESBATech AG
  25. Eye and ENT Hospital of Fudan University
  26. Eyegate Pharmaceuticals, Inc.
  27. Federal University of Rio de Janeiro
  28. Florida Eye Microsurgical Institute
  29. Formulario MAgistral Farmacias Ahumada
  30. Genentech
  31. GlaxoSmithKline
  32. Hanlim Pharm. Co., Ltd.
  33. Hiroshima University
  34. Hoffmann-La Roche
  35. Hospital General Universitari Vall d'Hebron
  36. Human Genome Sciences Inc.
  37. I.M. Sechenov First Moscow State Medical University (MSMU)
  38. Innovative Medical
  39. InSite Vision
  40. Inspire Pharmaceuticals
  41. Instituto Universitario de Oftalmobiología Aplicada
  42. Kanazawa Medical University
  43. Keio University School of Medicine
  44. Kissei Pharmaceutical Co., Ltd.
  45. Kresge Eye Institute
  46. KT&G Life Sciences Corp
  47. Kyoto Prefectural University of Medicine
  48. Laurantis Pharma
  49. Lee's Pharmaceuticals (China, Taiwan)
  50. Lµbris
  51. Lux Biosciences, Inc.
  52. Macusight
  53. Mahidol University
  54. Massachusetts Eye and Ear Infirmary
  55. Medical University of South Carolina
  56. Merck
  57. MGI Pharma
  58. Michigan Cornea Consultants, PC
  59. Mimetogen Pharmaceuticals USA, Inc.
  60. Minamiaoyama Eye Clinic
  61. Mitotech, SA
  62. Nagasaki University Graduate School of Biomedical Sciences
  63. Nascent Pharmaceuticals
  64. National Eye Institute (NEI)
  65. National Institute of Allergy and Infectious Diseases (NIAID)
  66. National Institute of Dental and Craniofacial Research (NIDCR)
  67. National Institutes of Health Clinical Center (CC)
  68. Nihon University School of Medicine
  69. Nippon Medical School
  70. Novagali Pharma
  71. Novartis
  72. Ophthalmic Consultants of Long Island
  73. OpthaliX
  74. Ora Inc.
  75. Osaka University Hospital
  76. Otsuka Pharmaceutical Co., Ltd.
  77. Pfizer
  78. Pontificia Universidad Catolica de Chile
  79. RegeneRx Biopharmaceuticals, Inc.
  80. Resolvyx Pharmaceuticals, Inc
  81. Rhodes Pharmaceuticals L.P.
  82. Rigel Pharmaceuticals
  83. Roche
  84. R-Tech Ueno, Ltd.
  85. Rush Medical College
  86. Santarus, Inc.
  87. Santen Inc.
  88. Santen Pharmaceutical Co., Ltd.
  89. Santen SAS (previously Novagali Pharma)
  90. SARcode Bioscience
  91. Seikagaku Corporation
  92. Shire Pharmaceuticals
  93. SIFI Pharma
  94. Sirion Therapeutics
  95. South Arizona VA Healthcare System
  96. Sun Yat-sen University
  97. Sylentis, S.A.
  98. Teika
  99. The Catholic University of Korea
  100. The Helmholtz Moscow Research Institute of Eye Diseases
  101. Tokai University School of Medicine
  102. Tokushima University Hospital
  103. Tokyo Dental College Ichikawa General Hospital
  104. Tokyo Electric Power Hospital
  105. Tufts University Dental School
  106. University Hospital, Brest
  107. University Hospital, Strasbourg, France
  108. University Medical Centre Groningen
  109. University of Alabama at Birmingham
  110. University of Ioannina, Greece
  111. University of Kitasato School of Medicine
  112. University of Miami
  113. University of Michigan
  114. University of Missouri-Columbia
  115. University of Pittsburgh School of Medicine
  116. University of Sao Paulo General Hospital
  117. University of Udine
  118. Valeant Pharmaceuticals
  119. Winston Laboratories


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