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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00420628
Other study ID # 459
Secondary ID
Status Completed
Phase Phase 4
First received January 8, 2007
Last updated September 30, 2011
Start date November 2006
Est. completion date June 2009

Study information

Verified date September 2011
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date June 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group N/A to 6 Years
Eligibility Inclusion Criteria:

- Child, 0 to 6 years of age, any sex and race

- Subject must have a clinical diagnosis of lid inflammation (e.g. Chalazion/Hordeolum) in at least one eye. If both eyes are diagnosed with lid inflammation, both eyes will be treated

- In good health (no current or past relevant medical history), based on the judgment of the investigator

- Parent/guardian is able and willing to follow instructions and provide informed consent

Exclusion Criteria:

- Known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication

- Known hypersensitivity to aminoglycosides, tobramycin, or any component of the study medication

- Use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (NSAID), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study

- Use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study

- Use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration

- Use of topical ophthalmic antibiotics (other than the study medication) within 72 hours before and during the study

- History of ocular surgery, including laser procedures, within the past six months

- Anticipation that surgical intervention for lid inflammation will be required prior to completion of the study

- Subjects with suspected vernal conjunctivitis, glaucoma of any kind, viral or bacterial conjunctivitis, preseptal cellulitis requiring systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication

- History of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study

- Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study

- Unlikely to comply with the protocol instructions for any reason

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
loteprednol etabonate/tobramycin opthalmic suspension
Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.
vehicle
topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.

Locations

Country Name City State
United States Pediatric Ophthalmology of Erie Erie Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment Emergent Adverse Events Study eye - Safety Population, At all visits 1,2,3 day 1, day 8, day 15 No
Secondary Investigators Global Assessment of the Clinical Condition The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened. Visit 3, day 8 No
Secondary Assessment of Ocular Signs in the Study Eye - Visit 1 Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. Visit 1 (day 1) No
Secondary Assessment of Ocular Signs in the Study Eye - Visit 2 Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. Visit 2 (day 8) No
Secondary Assessment of Ocular Signs in the Study Eye - Visit 3 Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe. Visit 3 (day 15) No
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Recruiting NCT02025023 - Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study Phase 3
Recruiting NCT05512572 - Therapeutic Efficacy of Intense Pulsed Light in the Treatment of Chalazion N/A