Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye

Condition(s) targeted: Dry Eye

Intervention: loteprednol etabonate ophthalmic suspension, 0.5% (Drug); loteprednol etabonate ophthalmic suspension, 0.5% (Drug); vehicle (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bausch & Lomb, Inc.

Official(s) and/or principal investigator(s):
Gail Torkildsen, MD, Principal Investigator, Affiliation: Ophthalmic Research Associates, Inc.

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.

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Corneal and conjunctival staining and conjunctival redness

Ocular discomfort during CAE exposure

Secondary outcome:

Corneal and conjunctival staining and conjunctival redness

Blink rate, Tear film break-up time (TFBUT), and Ocular Protection Index (OPI)

Ocular discomfort

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

- eported 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

Ophthalmic Research Associates, Andover, Massachusetts 01810, United States

Starting date: November 2005
Ending date: February 2006
Last updated: November 19, 2007