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Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

This study has been completed.
Sponsor:
Information provided by:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00560638
First received: November 19, 2007
Last updated: July 14, 2011
Last verified: July 2011

November 19, 2007
July 14, 2011
November 2005
February 2006   (final data collection date for primary outcome measure)
  • Ocular discomfort during CAE exposure [ Time Frame: during CAE exposure ] [ Designated as safety issue: No ]
  • Corneal and conjunctival staining and conjunctival redness [ Time Frame: After CAE exposure ] [ Designated as safety issue: No ]
  • Ocular discomfort during CAE exposure [ Time Frame: during CAE exposure ]
  • Corneal and conjunctival staining and conjunctival redness [ Time Frame: after CAE exposure ]
Complete list of historical versions of study NCT00560638 on ClinicalTrials.gov Archive Site
  • Corneal and conjunctival staining and conjunctival redness [ Time Frame: before CAE exposure ] [ Designated as safety issue: No ]
  • Blink rate, Tear film break-up time (TFBUT), and Ocular Protection Index (OPI) [ Time Frame: before after CAE exposure ] [ Designated as safety issue: No ]
  • Ocular discomfort [ Time Frame: collected in patient diaries ] [ Designated as safety issue: No ]
  • Corneal and conjunctival staining and conjunctival redness [ Time Frame: before CAE exposure ]
  • Blink rate, Tear film break-up time (TFBUT), and Ocular Protection Index (OPI) [ Time Frame: before after CAE exposure ]
  • Ocular discomfort [ Time Frame: collected in patient diaries ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dry Eye
  • Drug: loteprednol etabonate ophthalmic suspension, 0.5%
    TID
    Other Name: Lotemax
  • Drug: loteprednol etabonate ophthalmic suspension, 0.5%
    QID
    Other Name: Lotemax
  • Drug: vehicle of loteprednol etabonate
    TID or BID according to the randomization
  • Experimental: Loteprednol Etabonate TID
    loteprednol etabonate ophthalmic suspension, 0.5%, TID
    Intervention: Drug: loteprednol etabonate ophthalmic suspension, 0.5%
  • Experimental: Loteprednol Etabonate QID
    loteprednol etabonate ophthalmic suspension, 0.5%, QID
    Intervention: Drug: loteprednol etabonate ophthalmic suspension, 0.5%
  • Placebo Comparator: Vehicle
    vehicle of loteprednol etabonate
    Intervention: Drug: vehicle of loteprednol etabonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
February 2006
February 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00560638
439
No
Tuyen Ong, MD, Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Principal Investigator: Gail Torkildsen, MD Ophthalmic Research Associates, Inc.
Bausch & Lomb Incorporated
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP