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Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

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ClinicalTrials.gov Identifier: NCT00560638
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : July 18, 2011
Sponsor:
Information provided by:
Bausch & Lomb Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: loteprednol etabonate ophthalmic suspension, 0.5% Drug: vehicle of loteprednol etabonate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2005
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Loteprednol Etabonate TID
loteprednol etabonate ophthalmic suspension, 0.5%, TID
 Drug: loteprednol etabonate ophthalmic suspension, 0.5%
TID
Other Name: Lotemax
Experimental: Loteprednol Etabonate QID
loteprednol etabonate ophthalmic suspension, 0.5%, QID
 Drug: loteprednol etabonate ophthalmic suspension, 0.5%
QID
Other Name: Lotemax
Placebo Comparator: Vehicle
vehicle of loteprednol etabonate
 Drug: vehicle of loteprednol etabonate
TID or BID according to the randomization


Outcome Measures
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Primary Outcome Measures :
  1. Ocular discomfort during CAE exposure [ Time Frame: during CAE exposure ]
  2. Corneal and conjunctival staining and conjunctival redness [ Time Frame: After CAE exposure ]

Secondary Outcome Measures :
  1. Corneal and conjunctival staining and conjunctival redness [ Time Frame: before CAE exposure ]
  2. Blink rate, Tear film break-up time (TFBUT), and Ocular Protection Index (OPI) [ Time Frame: before after CAE exposure ]
  3. Ocular discomfort [ Time Frame: collected in patient diaries ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560638


Locations
United States, Massachusetts
Ophthalmic Research Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Gail Torkildsen, MD Ophthalmic Research Associates, Inc.
More Information
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Responsible Party: Tuyen Ong, MD, Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00560638     History of Changes
Other Study ID Numbers: 439
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: July 18, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
 Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Loteprednol Etabonate
Anti-Allergic Agents