Phase 4
Completed N=60
Efficacy of Zylet vs. Lotemax for the Treatment of Ocular Surface Inflammation/MGD/Blepharitis
Meibomian Gland Dysfunction · Posterior Blepharitis
Source: ClinicalTrials.gov NCT01456780 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Ocular Surface Disease Index — 56.6; 46.4; 48.4 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Surface Disease Index |
56.6; 46.4; 48.4 | — |
| PRIMARY Symptom Assessment iN Dry Eye (SANDE) Frequency Score |
65.9; 51.7; 50.5 | — |
| PRIMARY Symptom Assessment iN Dry Eye (SANDE) Severity Score |
64.5; 54.4; 51.2 | — |
| PRIMARY Corneal Fluorescein Staining Score |
6.3; 5.0; 4.8 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female
- At least 18 years of age
- Has not worn contact lenses, except for bandage contact lens or rigid gas permeable lens, for at least 2 weeks prior to the study and agrees to not wear contact lenses during study
- Patient is in generally good & stable overall health
- Minimum corneal fluorescein staining of 4 in at least one eye
- OSDI score >22
- The patient must have a diagnosis of posterior blepharitis
- A negative urine pregnancy test result for women of childbearing potential
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
- Normal lid position and closure
- Ability to understand and provide informed consent to participate in this study
- Willingness to follow study instructions and likely to complete all required visits
Exclusion Criteria
- History of Stevens-Johnson syndrome or ocular pemphigoid
- History of eyelid surgery
- Intra-ocular surgery or ocular laser surgery within 3 months
- History of microbial keratitis, including herpes
- Active ocular allergies
- Corneal epithelial defect > 1mm2
- Any change in use of topical anti-inflammatories, such as steroids, Restasis, or NSAID within the past 2 weeks
- Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the past two weeks
- Use of isotretinoin (Accutane) within the past 6 months
- Pregnant or lactating women
- Signs of current infection, including fever and current treatment with antibiotics
- Active liver, renal, or hematologic disease
- The use of any other investigational drug
- Individuals with a known history of glaucoma, individuals with IOP >22 Hg in either eye and individuals with a known family history of glaucoma in primary (first degree) relatives (ie. mother, father, sibling or child)
Data sourced from ClinicalTrials.gov (NCT01456780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.