NCT00518089

Brief Summary

The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
859

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

November 30, 2011

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

August 16, 2007

Results QC Date

June 15, 2010

Last Update Submit

April 10, 2019

Conditions

Bacterial Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge Up to Day 6

    Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe).

    6 Days

Secondary Outcomes (4)

  • Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6

    Day 6

  • Percentage of Patients With Microbiological Cure Up to Day 6

    6 Days

  • Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6

    6 Days

  • Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6

    6 Days

Study Arms (2)

Gatifloxacin 0.5% Eye Drops

EXPERIMENTAL

Gatifloxacin 0.5% Eye Drops

Drug: Gatifloxacin 0.5% eye drops

Placebo Eye Drops

PLACEBO COMPARATOR

Placebo Eye Drops

Drug: placebo eye drops

Interventions

Gatifloxacin 0.5% eye dropsDRUG

Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

Gatifloxacin 0.5% Eye Drops
placebo eye dropsDRUG

Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

Placebo Eye Drops

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosed with bacterial conjunctivitis

You may not qualify if:

  • Signs and/or symptoms of conjunctivitis for more than 96 hours
  • Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis
  • Clinical diagnosis of chlamydia in either eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Downey, California, United States

Location

Unknown Facility

RajajiNagar, Bangalore, India

Location

Related Publications (1)

  • Heller W, Cruz M, Bhagat YR, De Leon JM, Felix C, Villanueva L, Hollander DA, Jensen H. Gatifloxacin 0.5% administered twice daily for the treatment of acute bacterial conjunctivitis in patients one year of age or older. J Ocul Pharmacol Ther. 2014 Dec;30(10):815-22. doi: 10.1089/jop.2014.0040.

    PMID: 25244402BACKGROUND

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

GatifloxacinOphthalmic Solutions

Condition Hierarchy (Ancestors)

Eye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Results Point of Contact

Title
Therapeutic Area Head
Organization
Allergan, Inc.
clinicaltrials@allergan.com
(714) 246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2007

First Posted

August 20, 2007

Study Start

February 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

April 23, 2019

Results First Posted

November 30, 2011

Record last verified: 2019-04

Locations

US(1)IN(1)