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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00560638
Other study ID # 439
Secondary ID
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


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
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