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Completed

NCT Number: NCT00420628

Pediatric Zylet Safety and Efficacy Study

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)

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Key information

Conditions

Chalazion Bacterial Infections Bacterial Infections and Mycoses Cysts Eye Diseases Eye Infections Eye Infections, Bacterial Eyelid Diseases Hordeolum Infections Neoplasms

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pediatric Ophthalmology of Erie

Erie, Pennsylvania, 16501, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

loteprednol etabonate/tobramycin opthalmic suspension

Drug

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.

Other names: Zylet

Vehicle

Drug

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.

Primary outcomes

  1. Treatment Emergent Adverse Events

    Time frame: day 1, day 8, day 15

    Study eye - Safety Population, At all visits 1,2,3

Secondary outcomes

  1. Investigators Global Assessment of the Clinical Condition

    Time frame: Visit 3, day 8

    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.

  2. Assessment of Ocular Signs in the Study Eye - Visit 1

    Time frame: Visit 1 (day 1)

    Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.

  3. Assessment of Ocular Signs in the Study Eye - Visit 2

    Time frame: Visit 2 (day 8)

    Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.

  4. Assessment of Ocular Signs in the Study Eye - Visit 3

    Time frame: Visit 3 (day 15)

    Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Safety and Efficacy Study of Zylet® (Loteprednol Etabonate 0.5% and Tobramycin 0.3% Ophthalmic Suspension) Compared to Vehicle in the Management of Lid Inflammation (Chalazion/Hordeolum) in Pediatric Subjects

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 11, 2007
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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