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Completed

NCT Number: NCT00532961

Ocular Tolerance and Intraocular Pressure (IOP) Effects of Zylet Versus Tobradex

Phase IV, randomized, double-masked, parallel-group clinical trial comparing the ocular tolerability and steroid-induced intraocular pressure (IOP) effects of Zylet wth that of TobraDex in healthy volunteers, when either product was administered QID (at approximately 4-hour intervals) for 28 days.

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Key information

Conditions

Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • in good general health based on investigator judgment
  • able and willing to follow instructions, provide informed consent, make the required study visits, and use an electronic patient diary during the study
  • possessing a best corrected visual acuity of at least 20/40 in each eye
  • for females, using reliable contraception and a negative urine pregnancy test prior to study entry

Exclusion criteria

  • contact lenses worn within 30 days prior to enrollment or during study period
  • known hypersensitivity to study medication or any component
  • presence of significant ocular or systemic disease that might interfere with the interpretation of the results
  • a need for administration of chronic topical ocular or systemic medications of any kind during the study.
  • participation in an opthalmic drug or device research study within 30 days prior to entry

Treatment and study plan

Loteprednol etabonate 0.5% and tobramycin 0.3%

Drug

ophthalmic suspension, four times daily during the day at roughly 4 hour intervals(1-2 drops per eye)for a total of 28 days

Other names: Zylet

Dexamethasone 0.1% and tobramycin 0.3%

Drug

ophthalmic suspension, four times daily during the day at roughly 4 hour intervals (1-2 drops/eye) for a total of 28 days.

Other names: TobraDex

Primary outcomes

  1. Ocular comfort/tolerability

    Time frame: Day 1, 3, 8, 15, 22 and 29

  2. Intraocular pressure measurements

    Time frame: Day 1, 3, 8,15, 22 and 29

Secondary outcomes

  1. Assessment of safety

    Time frame: Througout 28-day study

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Randomized, Double-masked, Parallel Comparison of Ocular Tolerance and IOP Effects of Zylet vs TobraDex Administered Four Times Daily for Four Weeks in Healthy Volunteers

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 21, 2007
Registry last updated
Dec 8, 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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