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OpenTrials
Completed

NCT Number: NCT00447577

Zylet vs TobraDex in Blepharokeratoconjunctivitis

The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cornerstone Eye Care

High Point, North Carolina, 27262, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must be at least 18 years of age
  • Must be able and willing to comply with all treatment and follow up procedures
  • Must have the ability to understand and sign an Informed Consent Form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization
  • Must be able to self-administer drugs
  • Must have a clinical diagnosis of blepharokeratoconjunctivitis in at least one eye (total Ocular Signs and Symptoms score of at least 10, with at least one ocular sign and one ocular symptom each having a score of Grade 2 level or higher)
  • Women of childbearing potential must be sexually inactive or using an approved birth control methods and must have a negative urine pregnancy test
  • Must be willing to discontinue contact lens use for the duration of the study
  • Must have pin-holed Snellen visual acuity equal to or better than 20/40 in both eyes

Exclusion criteria

  • Any uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis)
  • Known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids
  • Use of any systemic or topical ophthalmic non-steroidal anti-inflammatory agents, analgesics, and antihistamines that cannot be discontinued during the study
  • Use of any topical ophthalmic medications, including tear substitutes, within 2 hours before and that cannot be discontinued during the study
  • Use of any systemic or topical ophthalmic antibiotic agents within 72 hours before and that cannot be discontinued during the study
  • Use of any systemic or topical ophthalmic corticosteroid agents within 7 days before and that cannot be discontinued during the study
  • Use of any systemic or topical ophthalmic mast cell stabilizers within 14 days before and that cannot be discontinued during the study
  • Use of any topical ophthalmic immunosuppressant (e.g. Restasis) agents within 30 days before and that cannot be discontinued during the study
  • Suspected preseptal cellulites, or any other disease conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug
  • Suspected dacrocystitis
  • Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study
  • Ocular surgery (including laser surgery) in either eye within the past 3 months

Treatment and study plan

Loteprednol etabonate and tobramycin ophthalmic suspension

Drug

Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

Tobramycin and dexamethasone ophthalmic suspension

Drug

Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

Primary outcomes

  1. The primary efficacy endpoint for this study is the change from baseline to Day 15 in the signs and symptoms composite score

    Time frame: 15 days

Secondary outcomes

  1. The distribution of Investigator global assessment at each visit.

    Time frame: Visit 2, 3 & 4

  2. The percentage of eyes that were considered improved or cured at each visit based on the Investigator global assessment.

    Time frame: Visit 2, 3 & 4

  3. The change from baseline to Day 7 (Visit 3) and to Day 3 (Visit 2) in the signs and symptoms composite score.

    Time frame: Visit 2 & 3

  4. The change from baseline to each visit in the signs composite score and the symptoms composite score.

    Time frame: Visit 1, 2, 3 & 4

  5. The change from baseline to each visit in the Blepharitis signs composite score, the conjunctivitis signs composite score, and the Keratitis signs composite score.

    Time frame: Visit 1, 2, 3 & 4

  6. The change from baseline to each visit in individual signs and symptoms.

    Time frame: Visit 1, 2, 3 & 4

  7. VA, Biomicroscopy, and IOP assessments at each visit

    Time frame: Visit 1, 2, 3 & 4

  8. Adverse Events

    Time frame: Visit 1, 2, 3 & 4

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Clinical Safety and Efficacy Evaluation of Zylet (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension) vs. Tobradex (Tobramycin and Dexamethasone Ophthalmic Suspension) in the Treatment of Blepharokeratoconjunctivitis

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 14, 2007
Registry last updated
Dec 9, 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.