Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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®

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Holprovision
Information provided by (Responsible Party):
Edward Holland, MD, Holprovision Identifier:
First received: January 3, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted

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 Intervention Phase
Dry Eye Disease
Drug: Loteprednol etabonate
Drug: Artificial Tears
Drug: Restasis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Holprovision:

Primary Outcome Measures:
  • Fluorescein corneal staining scores [ Time Frame: 60 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lissamine green conjunctival staining [ Time Frame: 60 Days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02028312

Contact: Kristin Williams

United States, California
Martel Eye Medical Group Recruiting
Rancho Cordova, California, United States, 95670
Principal Investigator: Joseph Martel, MD         
United States, Kentucky
Cincinnati Eye Institute Recruiting
Edgewood, Kentucky, United States, 41017
Principal Investigator: Edward Holland, MD         
United States, Minnesota
Associated Eye Care Recruiting
Stillwater, Minnesota, United States, 55082
Principal Investigator: Stephen Lane, MD         
Sponsors and Collaborators
Edward Holland, MD
  More Information

No publications provided

Responsible Party: Edward Holland, MD, Sponsor-Investigator, Holprovision Identifier: NCT02028312     History of Changes
Other Study ID Numbers: CEI.HER-002
Study First Received: January 3, 2014
Last Updated: January 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Holprovision:
Dry Eye

Additional relevant MeSH terms:
Loteprednol etabonate
Anti-Allergic Agents
Anti-Infective Agents
Antifungal Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 27, 2015