Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560638
• Other study ID #: 439
• Status: Completed
• Phase: Phase 2
• First received: November 19, 2007
• Last updated: July 14, 2011
• Start date: November 2005
• Est. completion date: February 2006

Study information

• Verified date: July 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• loteprednol etabonate ophthalmic suspension, 0.5%
TID
• loteprednol etabonate ophthalmic suspension, 0.5%
QID
• vehicle of loteprednol etabonate
TID or BID according to the randomization

Locations

Country	Name	City	State
United States	Ophthalmic Research Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular discomfort during CAE exposure		during CAE exposure	No
Primary	Corneal and conjunctival staining and conjunctival redness		After CAE exposure	No
Secondary	Corneal and conjunctival staining and conjunctival redness		before CAE exposure	No
Secondary	Blink rate, Tear film break-up time (TFBUT), and Ocular Protection Index (OPI)		before after CAE exposure	No
Secondary	Ocular discomfort		collected in patient diaries	No