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®

NCT02028312 | Withdrawn Phase 4

• 1 other identifier: CEI.HER-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Fluorescein corneal staining scores

  60 Days

Secondary Outcomes (1)

• Lissamine green conjunctival staining

  60 Days

Study Arms (2)

Loteprednol etabonate + Restasis

ACTIVE COMPARATOR

Loteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days

Drug: Loteprednol etabonate; Drug: Restasis

Artificial Tears + Restasis

PLACEBO COMPARATOR

Artificial Tears, BID 30 days Restasis, BID 45 days

Drug: Artificial Tears; Drug: Restasis

Interventions

Loteprednol etabonate DRUG

Loteprednol etabonate + Restasis

Artificial Tears DRUG

Artificial Tears + Restasis

Restasis DRUG

Artificial Tears + Restasis; Loteprednol etabonate + Restasis

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent prior to any study-related procedures and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
• Are between the ages of 21 and 80 inclusive.
• Have not worn contact lenses for at least 1 month prior to the study and agrees not to wear contact lenses during the study.
• Have been on stable oral medications for 1 month prior to the study.
• Are in generally good and stable overall health.
• 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.
• Are women who have undergone one of the following sterilization procedures at least 1 month prior to Visit 1:
• Bilateral tubal ligation
• Hysterectomy
• Hysterectomy with unilateral or bilateral oophorectomy.
• Bilateral oophorectomy
• Are likely to comply with the eye drop regime, study guidelines, and study visits.

You may not qualify if:

• Have a history of Stevens-Johnson Syndrome or ocular pemphigoid.
• Have had punctual plugs inserted or removed; or punctual cautery 3 months prior to Visit 1/Screening and Baseline Visit and throughout the study.
• Have had intra-ocular surgery within 6 months prior to the Visit 1/Screening and Baseline Visit.
• Have a history of liver disease.
• Be pregnant or lactating.
• Have severe clinical vitamin deficiencies or a history of vitamin overdose.
• Have a highly variable vitamin intake.
• Wear contact lenses.
• Have unstable use of systemic or topical medications known to create dry eye.
• Have corneal pathology, which could, of itself, cause an ocular surface disorder.
• Have used glaucoma medications, topical or oral within 30 days of Visit 1/Screening and Baseline Visit.
• Have unstable diabetes mellitus.
• Have an allergy or sensitivity to Lotemax® Gel, Restasis®, or non-preservative artificial tears.
• 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.
• Have a condition for which steroid use would be contraindicated (e.g. viral infection).

Sponsors & Collaborators

• Edward Holland, MD: lead

Study Sites (1)

Cincinnati Eye Institute

Edgewood, Kentucky, 41017, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Loteprednol Etabonate; Lubricant Eye Drops; Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: January 7, 2014
• Study Start: January 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

US (1)