Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye
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ClinicalTrials.gov Identifier: NCT00560638 |
Recruitment Status :
Completed
First Posted : November 20, 2007
Last Update Posted : July 18, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye | Drug: loteprednol etabonate ophthalmic suspension, 0.5% Drug: vehicle of loteprednol etabonate | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 119 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 Start Date : | November 2005 |
Actual Primary Completion Date : | February 2006 |
Actual Study Completion Date : | February 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: Loteprednol Etabonate TID
loteprednol etabonate ophthalmic suspension, 0.5%, TID
|
Drug: loteprednol etabonate ophthalmic suspension, 0.5%
TID
Other Name: Lotemax |
Experimental: Loteprednol Etabonate QID
loteprednol etabonate ophthalmic suspension, 0.5%, QID
|
Drug: loteprednol etabonate ophthalmic suspension, 0.5%
QID
Other Name: Lotemax |
Placebo Comparator: Vehicle
vehicle of loteprednol etabonate
|
Drug: vehicle of loteprednol etabonate
TID or BID according to the randomization |
- Ocular discomfort during CAE exposure [ Time Frame: during CAE exposure ]
- Corneal and conjunctival staining and conjunctival redness [ Time Frame: After CAE exposure ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560638
United States, Massachusetts | |
Ophthalmic Research Associates | |
Andover, Massachusetts, United States, 01810 |
Principal Investigator: | Gail Torkildsen, MD | Ophthalmic Research Associates, Inc. |
Responsible Party: | Tuyen Ong, MD, Bausch & Lomb Incorporated |
ClinicalTrials.gov Identifier: | NCT00560638 |
Other Study ID Numbers: |
439 |
First Posted: | November 20, 2007 Key Record Dates |
Last Update Posted: | July 18, 2011 |
Last Verified: | July 2011 |
Dry Eye Syndromes Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Eye Diseases Keratoconjunctivitis Conjunctivitis |
Conjunctival Diseases Keratitis Corneal Diseases Loteprednol Etabonate Anti-Allergic Agents |