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®

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.

Study Overview

• Status: Withdrawn
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: Restasis; Drug: Loteprednol etabonate; Drug: Artificial Tears

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Cincinnati Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Loteprednol etabonate + Restasis; Loteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days	Drug: Restasis; Drug: Loteprednol etabonate
PLACEBO_COMPARATOR: Artificial Tears + Restasis; Artificial Tears, BID 30 days Restasis, BID 45 days	Drug: Restasis; Drug: Artificial Tears

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fluorescein corneal staining scores	60 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Lissamine green conjunctival staining	60 Days

Collaborators and Investigators

• Sponsor: Edward Holland, MD

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (ANTICIPATED): February 1, 2016
• Study Completion (ANTICIPATED): June 1, 2016

Study Registration Dates

• First Submitted: January 3, 2014
• First Submitted That Met QC Criteria: January 3, 2014
• First Posted (ESTIMATE): January 7, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Dry Eye
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Anti-Allergic Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Loteprednol Etabonate; Lubricant Eye Drops
• Other Study ID Numbers: CEI.HER-002