Trial | NCT03975374  Report issue

Title

To Study Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension
Efficacy and Safety of Tobradex Eye Drop Suspension vs Tobramycin/Dexamethasone Ophthalmic Suspension

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    5000
The objective of the study is to compare and describe efficacy and safety of Tobradex ophthalmic suspension versus generic Tobramycin/dexamethasone Suspension in treatment of Blepharoconjuctivitis through clinical parameters
Evaluation of signs and symptoms during treatment, with a record of individual scores for each parameter; Observation and statistical comparison of drug safety, by recording qualitative and quantitative parameters related to adverse effects occurring during treatment.
Study Started
Jun 15
2019
Anticipated
Primary Completion
Jul 01
2019
Anticipated
Study Completion
Jun 30
2020
Anticipated
Last Update
Jun 05
2019

Drug Tobramycin/dexamethasone opthalmic solution [tobramycin (nebcin), dexamethasone]

To compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution

  • Other names: Tobradex

Drug Tobradex Opthalmic Solution [tobramycin (nebcin), dexamethasone]

Tobradex Opthalmic Solution

Tobramycin/Dexamethasone opthamic Solution Experimental

This group of randomized patients will be instructed to instill 2 gtt of Tobramycin/Dexamethasone opthamic solution every 6 hours for 10 days

Tobradex Opthalmic Solution Active Comparator

This group of randomized patients will be instructed to instill 2 gtt of Tobradex Opthalmic Solution every 6 hours for 10 days

Criteria 

Inclusion Criteria:

All potential subjects with symptomatic blepharitis examined to have blepharitis with healthy mental status, able to give consent, with/without co-existing medical conditions will be considered

Exclusion Criteria:

All subjects with history and/or probable history of allergic reaction to tobramycin/dexamethasone and all subjects who have mental disability and are unable to give direct consent will be excluded
No Results Posted