A Phase 4 interventional study of Loteprednol/tobramycin and Loteprednol in Meibomian Gland Dysfunction and Posterior Blepharitis, sponsored by Massachusetts Eye and Ear Infirmary. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by Massachusetts Eye and Ear Infirmary · Phase 4, Interventional, and Treatment
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.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Loteprednol/tobramycin
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.
Drug: Loteprednol
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.
Drug: B+L Advanced Eye Relief Lubricant Drop
Drug pages: Loteprednol Etabonate · Tobramycin
Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
Also known as: Zylet
Eye drops, 1 drop twice a day for 4 weeks
Also known as: Lotemax
Bausch + Lomb (B+L) Advanced Eye Relief Lubricant Drop (Artificial Tears), 1 drop twice a day for 4 weeks.
Also known as: artificial tears
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 4 Time Point
| Milestone | Zylet | Lotemax | Bausch & Lomb Lubricant Drops |
|---|---|---|---|
| Started | 20 | 20 | 20 |
| Completed | 17 | 17 | 20 |
| Not completed | 3 | 3 | 0 |
| Withdrew: Lost to follow-up | 3 | 3 | 0 |
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.
| units on a scale | Zylet | Lotemax | Bausch & Lomb Lubricant Drops |
|---|---|---|---|
| Ocular Surface Disease Index | 56.6 ± 22.4 | 46.4 ± 24.8 | 48.4 ± 18.9 |
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.
| units on a scale | Zylet | Lotemax | Bausch & Lomb Lubricant Drops |
|---|---|---|---|
| Symptom Assessment iN Dry Eye (SANDE) Frequency Score | 65.9 ± 28.9 | 51.7 ± 23.3 | 50.5 ± 24.3 |
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.
| units on a scale | Zylet | Lotemax | Bausch & Lomb Lubricant Drops |
|---|---|---|---|
| Symptom Assessment iN Dry Eye (SANDE) Severity Score | 64.5 ± 25.8 | 54.4 ± 20.2 | 51.2 ± 22.0 |
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.
| units on a scale | Zylet | Lotemax | Bausch & Lomb Lubricant Drops |
|---|---|---|---|
| Corneal Fluorescein Staining Score | 6.3 ± 4.2 | 5.0 ± 3.3 | 4.8 ± 3.2 |
Collected over 4 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zylet | 0/20 (0%) | 0/20 (0%) | 2/20 (10%) |
| Lotemax | 0/20 (0%) | 0/20 (0%) | 1/20 (5%) |
| Bausch & Lomb Lubricant Drops | 0/20 (0%) | 0/20 (0%) | 2/20 (10%) |
| Event | Zylet | Lotemax | Bausch & Lomb Lubricant Drops |
|---|---|---|---|
| Eye PainEye disorders | 1/20 | 0/20 | 0/20 |
| BlurrinessEye disorders | 1/20 | 1/20 | 0/20 |
| Excess TearingEye disorders | 1/20 | 0/20 | 0/20 |
| RednessEye disorders | 1/20 | 0/20 | 0/20 |
| HeadacheEye disorders | 0/20 | 0/20 | 1/20 |
| ShinglesEye disorders | 0/20 | 0/20 | 1/20 |
| DrynessEye disorders | 0/20 | 1/20 | 0/20 |
| Age, Continuous(years) | Zylet | Lotemax | Bausch & Lomb Lubricant Drops | Total |
|---|---|---|---|---|
| Mean | 55 ± 13 | 52 ± 12 | 57 ± 12 | 55 ± 13 |
| Sex: Female, Male(Participants) | Zylet | Lotemax | Bausch & Lomb Lubricant Drops | Total |
|---|---|---|---|---|
| Female | 8 | 9 | 15 | 32 |
| Male | 9 | 8 | 5 | 22 |
| Ocular Surface Disease Index(units on a scale) | Zylet | Lotemax | Bausch & Lomb Lubricant Drops | Total |
|---|---|---|---|---|
| Mean | 59.7 ± 18.0 | 52.0 ± 22.6 | 57.0 ± 21.3 | 56.3 ± 20.6 |
| Symptom Assessment in Dry Eye (SANDE) Frequency Score(units on a scale) | Zylet | Lotemax | Bausch & Lomb Lubricant Drops | Total |
|---|---|---|---|---|
| Mean | 77.8 ± 14.2 | 60.9 ± 19.4 | 68.1 ± 17.8 | 68.9 ± 18.3 |
| Symptom Assessment in Dry Eye (SANDE) Severity Score(units on a scale) | Zylet | Lotemax | Bausch & Lomb Lubricant Drops | Total |
|---|---|---|---|---|
| Mean | 67.0 ± 19.8 | 58.1 ± 19.6 | 64.2 ± 19.5 | 63.2 ± 19.6 |
| Corneal Fluorescein Staining (CFS)(units on a scale) | Zylet | Lotemax | Bausch & Lomb Lubricant Drops | Total |
|---|---|---|---|---|
| Mean | 6.8 ± 2.6 | 6.6 ± 2.5 | 6.1 ± 2.0 | 6.5 ± 2.3 |
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Studies of the drugs tested here: Loteprednol Etabonate · Tobramycin
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