Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis (ZvL)
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ClinicalTrials.gov Identifier: NCT01456780 |
Recruitment Status
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Completed
First Posted
: October 21, 2011
Results First Posted
: June 19, 2017
Last Update Posted
: August 1, 2017
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Tracking Information | |||||||
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First Submitted Date ICMJE | August 2, 2011 | ||||||
First Posted Date ICMJE | October 21, 2011 | ||||||
Results First Submitted Date | April 6, 2017 | ||||||
Results First Posted Date | June 19, 2017 | ||||||
Last Update Posted Date | August 1, 2017 | ||||||
Actual Study Start Date ICMJE | August 2011 | ||||||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Efficacy of Treatment [ Time Frame: 4 and 8 weeks after taking the first dose ] Efficacy will be evaluated comparing a change from baseline in symptom questionnaires, presence of inflammatory cells, and lid and gland evaluation scores.
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Change History | Complete list of historical versions of study NCT01456780 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis | ||||||
Official Title ICMJE | Relative Efficacy of Loteprednol (Lotemax®) vs. Loteprednol/Tobramycin (Zylet®) in Treatment of Chronic Ocular Surface Inflammation Associated With Meibomian Gland Dysfunction (MGD)/Posterior Blepharitis | ||||||
Brief Summary | This is a Phase IV, single site, randomized, double masked, parallel control clinical trial of 60 subjects to investigate the variance of efficacy between Lotemax® and Zylet® for treatment of ocular surface inflammation due to meibomian gland dysfunction (MGD). Efficacy will be measured by in-vivo confocal microscopy, corneal fluorescein staining, grading of meibomian gland dysfunction and validated ocular symptom assessment questionnaire. | ||||||
Detailed Description | Posterior blepharitis is a common chronic eyelid condition that is described as generalized inflammation of the posterior lid margin and associated with inflammation of the ocular surface and with symptoms of burning, irritation, and discomfort. Posterior blepharitis is associated with various disorders of the meibomian glands, known collectively as meibomian gland dysfunction (MGD). It is associated either with obstruction and inflammation of the meibomian glands or, less commonly, atrophy of the meibomian glands. Clinically, MGD often presents with inspissated meibomian glands, oily tear film, as well as inflammation and vascularization of the meibomian gland orifices. Papillary hypertrophy of the tarsal conjunctiva and corneal punctate epitheliopathy are often present, and there are prominent associations with dermatoses, such as acne rosacea, seborrhoeic dermatitis, and atopic dermatitis. Evidence from several sources suggests that MGD of sufficient extent and degree is associated with a deficient tear lipid layer, an increase in tear evaporation, and the occurrence of an evaporative dry eye. In fact MGD is considered to be the most common cause of evaporative dry eye. Individuals with MGD often complain of significant discomfort, including burning, itching, irritation, and photophobia. They may also have other associated symptoms of dry eye and may be plagued by blurred vision, gradual contact lens intolerance. Furthermore, these patients may become functionally handicapped by the negative impact of dry eye on their crucial daily activities such as working, reading, using computer, and driving. Despite the high incidence of posterior blepharitis, there is currently no consistently effective treatment for this condition and it still remains a therapeutic challenge. Posterior blepharitis has traditionally been managed with eyelid hygiene, topical antibiotics (erythromycin or bacitracin ointments), oral tetracyclines (tetracycline, doxycycline, or minocycline) and corticosteroids which are often time consuming, frustrating, and frequently ineffective or variably effective. The purpose of this study is to compare the effectiveness of topical loteprednol (corticosteroid) vs. the combination of loteprednol and tobramycin (corticosteroid and antibiotic) against an artificial tear. It is critical to determine to what extent the addition of an antibiotic to a topical steroid can enhance the therapeutic efficacy of the treatment. |
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Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
60 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date | June 2017 | ||||||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
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Administrative Information | |||||||
NCT Number ICMJE | NCT01456780 | ||||||
Other Study ID Numbers ICMJE | 11-048H | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Reza Dana, MD, Massachusetts Eye and Ear Infirmary | ||||||
Study Sponsor ICMJE | Massachusetts Eye and Ear Infirmary | ||||||
Collaborators ICMJE | Bausch & Lomb Incorporated | ||||||
Investigators ICMJE |
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PRS Account | Massachusetts Eye and Ear Infirmary | ||||||
Verification Date | July 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |