Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye - Full Text View

Purpose

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	Intervention	Phase
Dry Eye	Drug: loteprednol etabonate ophthalmic suspension, 0.5% Drug: vehicle	Phase II

ChemIDplus related topics:

Loteprednol Loteprednol etabonate

U.S. FDA Resources

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

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

Further study details as provided by Bausch & Lomb, Inc.:

Primary Outcome Measures:

Corneal and conjunctival staining and conjunctival redness [ Time Frame: after CAE exposure ]
Ocular discomfort during CAE exposure [ Time Frame: during CAE exposure ]

Secondary Outcome Measures:

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 ]

Enrollment:	119
Study Start Date:	November 2005
Study Completion Date:	February 2006

Arms	Assigned Interventions
1: Experimental loteprednol etabonate ophthalmic suspension, 0.5%, TID	Drug: loteprednol etabonate ophthalmic suspension, 0.5% TID
2: Experimental loteprednol etabonate ophthalmic suspension, 0.5%, QID	Drug: loteprednol etabonate ophthalmic suspension, 0.5% QID
3: Placebo Comparator vehicle	Drug: vehicle TID or BID according to the randomization

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560638

Locations


United States, Massachusetts
	Ophthalmic Research Associates
	Andover, Massachusetts, United States, 01810

Sponsors and Collaborators

Bausch & Lomb, Inc.

Investigators


Principal Investigator:	Gail Torkildsen, MD	Ophthalmic Research Associates, Inc.

More Information

Study ID Numbers:	439
First Received:	November 19, 2007
Last Updated:	November 19, 2007
ClinicalTrials.gov Identifier:	NCT00560638
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Loteprednol etabonate

Additional relevant MeSH terms:

Therapeutic Uses

Anti-Allergic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00560638