A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02028312
Recruitment Status : Withdrawn (Per Sponsor)
First Posted : January 7, 2014
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
Edward Holland, MD, Holprovision

Brief Summary:
A pilot study to evaluate the impact of Lotemax® Gel (loteprednol etabonate ophthalmic gel 0.5%) on the initiation of Restasis® (cyclosporine ophthalmic emulsion 0.05%) therapy in subjects with dry eye.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: Loteprednol etabonate Drug: Artificial Tears Drug: Restasis Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : January 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Loteprednol etabonate + Restasis
Loteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days
Drug: Loteprednol etabonate Drug: Restasis
Placebo Comparator: Artificial Tears + Restasis
Artificial Tears, BID 30 days Restasis, BID 45 days
Drug: Artificial Tears Drug: Restasis

Primary Outcome Measures :
  1. Fluorescein corneal staining scores [ Time Frame: 60 Days ]

Secondary Outcome Measures :
  1. Lissamine green conjunctival staining [ Time Frame: 60 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Provide written informed consent prior to any study-related procedures and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
  2. Are between the ages of 21 and 80 inclusive.
  3. Have not worn contact lenses for at least 1 month prior to the study and agrees not to wear contact lenses during the study.
  4. Have been on stable oral medications for 1 month prior to the study.
  5. Are in generally good and stable overall health.
  6. Are a woman of child bearing potential (WOCBP) who is not pregnant or lactating and not sexually active (i.e. abstinent) at Visit 1 and willing to remain so through Visit 4. Alternatively, a WOCBP who is not abstinent must have been using an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study.
  7. Are women who have undergone one of the following sterilization procedures at least 1 month prior to Visit 1:

    1. Bilateral tubal ligation
    2. Hysterectomy
    3. Hysterectomy with unilateral or bilateral oophorectomy.
    4. Bilateral oophorectomy
  8. Are likely to comply with the eye drop regime, study guidelines, and study visits.

Exclusion Criteria:

  1. Have a history of Stevens-Johnson Syndrome or ocular pemphigoid.
  2. Have had punctual plugs inserted or removed; or punctual cautery 3 months prior to Visit 1/Screening and Baseline Visit and throughout the study.
  3. Have had intra-ocular surgery within 6 months prior to the Visit 1/Screening and Baseline Visit.
  4. Have a history of liver disease.
  5. Be pregnant or lactating.
  6. Have severe clinical vitamin deficiencies or a history of vitamin overdose.
  7. Have a highly variable vitamin intake.
  8. Wear contact lenses.
  9. Have unstable use of systemic or topical medications known to create dry eye.
  10. Have corneal pathology, which could, of itself, cause an ocular surface disorder.
  11. Have used glaucoma medications, topical or oral within 30 days of Visit 1/Screening and Baseline Visit.
  12. Have unstable diabetes mellitus.
  13. Have an allergy or sensitivity to Lotemax® Gel, Restasis®, or non-preservative artificial tears.
  14. Have used topical steroids or Restasis® within 1 month prior to the Screening and Baseline Visit and throughout the study, except the study medication provided per the protocol.
  15. Have a condition for which steroid use would be contraindicated (e.g. viral infection).
  16. Use other topical ocular agents other than tear replacements within 1 week prior to the Screening and Baseline Visit and throughout the study.
  17. Have been exposed to an investigational drug within the preceding 30 days.
  18. In the opinion of the investigator or study coordinator, be unwilling or unable to comply with the study protocol or unable to successfully instill eye drops.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02028312

United States, Kentucky
Cincinnati Eye Institute
Edgewood, Kentucky, United States, 41017
Sponsors and Collaborators
Edward Holland, MD

Responsible Party: Edward Holland, MD, Sponsor-Investigator, Holprovision Identifier: NCT02028312     History of Changes
Other Study ID Numbers: CEI.HER-002
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Edward Holland, MD, Holprovision:
Dry Eye

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Lubricant Eye Drops
Loteprednol Etabonate
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Allergic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors