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| Name | Class |
|---|---|
| Bausch & Lomb Incorporated | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zylet | Active Comparator | Subject randomized to this arm will be treated with Zylet (Loteprednol/tobramycin), twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic. |
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| Lotemax | Active Comparator | Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. |
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| B+L Advanced Eye Relief Lubricant Drop | Placebo Comparator | Subject randomized to this arm will be treated with B+L Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), twice a day, for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loteprednol/tobramycin | Drug | Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index | OSDI is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. | Week 4 Time Point |
| Symptom Assessment iN Dry Eye (SANDE) Frequency Score | Questionnaire given to patients to assess the frequency of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the frequency of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of frequency of dry eye symptoms and 100 being the maximum level of frequency of dry eye symptoms. | Week 4 Time Point |
| Symptom Assessment iN Dry Eye (SANDE) Severity Score | Questionnaire given to patients to assess the severity of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the severity of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE severity scale is 0-100, with minimum level of severity of dry eye symptoms and 100 being the maximum level of severity of dry eye symptoms. | Week 4 Time Point |
| Corneal Fluorescein Staining Score | Corneal Fluorescein Staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of corneal epitheliopathy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Dana, MD, MPH, MSc | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye & Ear Infirmary | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zylet | Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic. Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Loteprednol | Drug | Eye drops, 1 drop twice a day for 4 weeks |
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| B+L Advanced Eye Relief Lubricant Drop | Drug | Bausch + Lomb (B+L) Advanced Eye Relief Lubricant Drop (Artificial Tears), 1 drop twice a day for 4 weeks. |
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| Week 4 Time Point |
| FG001 | Lotemax | Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Loteprednol: Eye drops, 1 drop twice a day for 4 weeks |
| FG002 | Bausch & Lomb Lubricant Drops | Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks. Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zylet | Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Tobramycin is an antibiotic. Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks. |
| BG001 | Lotemax | Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation. Loteprednol: Eye drops, 1 drop twice a day for 4 weeks |
| BG002 | Bausch & Lomb Lubricant Drops | Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks. Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ocular Surface Disease Index | The Ocular Surface Disease Index score ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms | Mean | Standard Deviation | units on a scale |
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| Symptom Assessment in Dry Eye (SANDE) Frequency Score | The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of frequency of dry eye symptoms and 100 being the maximum level of frequency of dry eye symptoms. | Mean | Standard Deviation | units on a scale |
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| Symptom Assessment in Dry Eye (SANDE) Severity Score | The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of severity of dry eye symptoms and 100 being the maximum level of severity of dry eye symptoms. | Mean | Standard Deviation | units on a scale |
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| Corneal Fluorescein Staining (CFS) | The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of corneal epitheliopathy. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ocular Surface Disease Index | OSDI is a 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. | Posted | Mean | Standard Deviation | units on a scale | Week 4 Time Point |
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| Primary | Symptom Assessment iN Dry Eye (SANDE) Frequency Score | Questionnaire given to patients to assess the frequency of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the frequency of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE frequency scale is 0-100, with 0 being the minimum level of frequency of dry eye symptoms and 100 being the maximum level of frequency of dry eye symptoms. | Posted | Mean | Standard Deviation | units on a scale | Week 4 Time Point |
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| Primary | Symptom Assessment iN Dry Eye (SANDE) Severity Score | Questionnaire given to patients to assess the severity of dry eye symptoms. The questionnaire utilizes a 100 mm horizontal Visual Analogue Scale technique to quantify the severity of the patient's dry eye symptoms. Change is quantified from baseline to week 4. The range of the SANDE severity scale is 0-100, with minimum level of severity of dry eye symptoms and 100 being the maximum level of severity of dry eye symptoms. | Posted | Mean | Standard Deviation | units on a scale | Week 4 Time Point |
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| Primary | Corneal Fluorescein Staining Score | Corneal Fluorescein Staining is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of corneal epitheliopathy. | Posted | Mean | Standard Deviation | units on a scale | Week 4 Time Point |
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4 Weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zylet | Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling). Tobramycin is an antibiotic. Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks. | 0 | 20 | 0 | 20 | 2 | 20 |
| EG001 | Lotemax | Subject randomized to this arm will be treated with Lotemax, twice a day, for 4 weeks. Lotemax is also known as loteprednol. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling). Loteprednol: Eye drops, 1 drop twice a day for 4 weeks | 0 | 20 | 0 | 20 | 1 | 20 |
| EG002 | Bausch & Lomb Lubricant Drops | Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks. Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks. | 0 | 20 | 0 | 20 | 2 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Pain | Eye disorders | Non-systematic Assessment |
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| Blurriness | Eye disorders | Blurriness | Non-systematic Assessment |
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| Excess Tearing | Eye disorders | Excess Tearing | Non-systematic Assessment |
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| Redness | Eye disorders | Redness | Non-systematic Assessment |
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| Headache | Eye disorders | Headache | Non-systematic Assessment |
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| Shingles | Eye disorders | Non-systematic Assessment |
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| Dryness | Eye disorders | Dryness | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Reza Dana | Massachusetts Eye and Ear | 617-573-4431 | 4431 | Reza_Dana@meei.harvard.edu |
| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| D001762 | Blepharitis |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D007766 | Lacrimal Apparatus Diseases |
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| ID | Term |
|---|---|
| D000069559 | Loteprednol Etabonate |
| D014031 | Tobramycin |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
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| Male |
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Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks. Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks. |
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Subject randomized to this arm will be treated with artificial tears, twice a day, for 4 weeks. Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops: Bausch + Lomb Advanced Eye Relief Lubricant Eye Drops (Artificial Tears), 1 drop twice a day for 4 weeks. |
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