Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

NCT00560638 | Completed Phase 2

• 1 other identifier: 439
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Ocular discomfort during CAE exposure

  during CAE exposure

• Corneal and conjunctival staining and conjunctival redness

  After CAE exposure

Secondary Outcomes (3)

• 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

Study Arms (3)

Loteprednol Etabonate TID

EXPERIMENTAL

loteprednol etabonate ophthalmic suspension, 0.5%, TID

Drug: loteprednol etabonate ophthalmic suspension, 0.5%

Loteprednol Etabonate QID

EXPERIMENTAL

loteprednol etabonate ophthalmic suspension, 0.5%, QID

Drug: loteprednol etabonate ophthalmic suspension, 0.5%

Vehicle

PLACEBO COMPARATOR

vehicle of loteprednol etabonate

Drug: vehicle of loteprednol etabonate

Interventions

loteprednol etabonate ophthalmic suspension, 0.5% DRUG

TID

Also known as: Lotemax

Loteprednol Etabonate TID

vehicle of loteprednol etabonate DRUG

TID or BID according to the randomization

Vehicle

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Ophthalmic Research Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Gail Torkildsen, MD

  Ophthalmic Research Associates, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 20, 2007
• Study Start: November 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: July 18, 2011

Record last verified: 2011-07

Locations

US (1)