Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

A Double-Masked, Randomized, Placebo-Controlled Study of Loteprednol Etabonate Ophthalmic Suspension, 0.5% for the Treatment of Dry Eye Used Either TID or QID for a 2 Week Period

This was a single-center, randomized, double-masked, placebo-controlled, parallel-group, 4-visit, CAE (Controlled Adverse Environment) study lasting approximately 4 weeks. Subjects were randomized to receive loteprednol etabonate ophthalmic suspension, 0.5% or placebo (vehicle of loteprednol etabonate ophthalmic suspension, 0.5%) and instructed to dose bilaterally either TID or QID according to randomization.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Drug: loteprednol etabonate ophthalmic suspension, 0.5%; Drug: loteprednol etabonate ophthalmic suspension, 0.5%; Drug: vehicle of loteprednol etabonate

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Ophthalmic Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• at least 18 years of age or older
• able and willing to follow instructions, including participation in study assessments and able be present for the required study visits for the duration of the study
• If female and of childbearing potential, were not pregnant, nursing, or planning a pregnancy. Women of childbearing potential were required to have a negative urine pregnancy test at the pre-screen visit and had to agree to use an acceptable method of mechanical or hormonal contraceptive for the duration of the study
• a diagnosis of dry eye
• a history of intermittent or regular artificial tear use within the past 3 months
• best corrected visual acuity (BCVA) of +0.7 or better assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in one or both eyes
• a fluorescein staining score of ≥ 1+ in at least one region in at least one eye at Visit 1 and before CAE exposure at Visits 2 and 3 OR a fluorescein staining score of ≥ 1+ in at least one region in at least one eye at Visit 1 and before CAE exposure at Visits 2 and 3 with a conjunctival redness score of ≥ 1.5+ at Visit 1 and before CAE exposure at Visits 2 and 3 in at least one eye
• Demonstrated a response when exposed to the CAE at Visits 2 and 3

Exclusion Criteria:

• clinically significant blepharitis or Meibomian Gland Dysfunction (MGD) or lid margin inflammation, particularly if systemic or topical medications were currently being used to treat any of these diagnoses
• diagnosed with an on-going ocular infection (bacterial, viral, or fungal), or active ocular inflammation (e.g. follicular conjunctivitis), or preauricular lymphadenopathy, particularly if systemic or topical medications were currently being used to treat any of these diagnoses
• Reported an ocular discomfort score of 4+ in both eyes at time 0 of CAE exposure at Visits 2 or 3
• Wore contact lenses and refused to remove them for the duration of the study
• previous laser in situ keratomileusis (LASIK) surgery
• currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs and could not discontinue these medications for the duration of the study
• presently taking any medication known to cause ocular drying that had not been a stable dose for at least 30 days
• currently taking oral antihistamines that could not be discontinued during the study
• a systemic disease, uncontrolled medical condition that in the opinion of the investigator could interfere with study measurements or subject compliance
• received another experimental drug or device within 30 days prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Loteprednol Etabonate TID; loteprednol etabonate ophthalmic suspension, 0.5%, TID	Drug: loteprednol etabonate ophthalmic suspension, 0.5%; TID; Other Names: Lotemax; Drug: loteprednol etabonate ophthalmic suspension, 0.5%; QID; Other Names: Lotemax
Experimental: Loteprednol Etabonate QID; loteprednol etabonate ophthalmic suspension, 0.5%, QID	Drug: loteprednol etabonate ophthalmic suspension, 0.5%; TID; Other Names: Lotemax; Drug: loteprednol etabonate ophthalmic suspension, 0.5%; QID; Other Names: Lotemax
Placebo Comparator: Vehicle; vehicle of loteprednol etabonate	Drug: vehicle of loteprednol etabonate; TID or BID according to the randomization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ocular discomfort during CAE exposure	during CAE exposure
Corneal and conjunctival staining and conjunctival redness	After CAE exposure

Secondary Outcome Measures

Outcome Measure	Time Frame
Corneal and conjunctival staining and conjunctival redness	before CAE exposure
Blink rate, Tear film break-up time (TFBUT), and Ocular Protection Index (OPI)	before after CAE exposure
Ocular discomfort	collected in patient diaries

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Gail Torkildsen, MD, Ophthalmic Research Associates, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): February 1, 2006
• Study Completion (Actual): February 1, 2006

Study Registration Dates

• First Submitted: November 19, 2007
• First Submitted That Met QC Criteria: November 19, 2007
• First Posted (Estimate): November 20, 2007

Study Record Updates

• Last Update Posted (Estimate): July 18, 2011
• Last Update Submitted That Met QC Criteria: July 14, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Anti-Allergic Agents; Loteprednol Etabonate
• Other Study ID Numbers: 439