Bacterial ConjunctivitisPhase 3NCT00509873
A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
A Phase 3 study testing Gatifloxacin 0.5% eye drops in people with Bacterial Conjunctivitis, run by Allergan at 1 site in United States.
Trial summary
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Bacterial Conjunctivitis
- What is being tested?
- Gatifloxacin 0.5% eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 578 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinically diagnosed with bacterial conjunctivitis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis
- Conditions
- Bacterial Conjunctivitis
- Being tested
- Gatifloxacin 0.5% eye drops, placebo eye drops
- Medical subject headings
- Conjunctivitis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
placebo eye dropsDrug
Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
| Study group | Role | What they receive |
|---|---|---|
| Gatifloxacin 0.5% Eye Drops | Experimental | Gatifloxacin 0.5% Eye Drops Receives: Drug: Gatifloxacin 0.5% eye drops |
| Placebo Eye Drops | Placebo comparator | Placebo Eye Drops Receives: Drug: placebo eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at 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 at 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).
Measured: Day 6
Secondary outcomes (3)
Percentage of Patients With Microbiological Cure at Day 6
Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated (or absent) at Day 6 based on a Classification of Microbial Response. (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture)
Measured: Day 6
Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6
Percentage of patients with clinical improvement of ocular signs at Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus),with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye.
Measured: Day 6
Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6
Percentage of patients with clinical improvement of ocular symptoms at Day 6, defined as a decrease (improvement) from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis
Measured: Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 578 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509873
- Sponsor's protocol ID
- 198782-004
- Status last verified
- Oct 2011
- First submitted
- 30 Jul 2007
- Last updated
- 30 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 25244402
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
- ClinicalTrials.gov ID
- NCT00509873
- Acronym / sponsor ID
- 198782-004
- Conditions
- Bacterial Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 Aug 2007 (estimated)
- Results
- Posted 30 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gatifloxacin 0.5% Eye Drops | Experimental | Drug: Gatifloxacin 0.5% eye dropsGatifloxacin 0.5% Eye Drops |
| Placebo Eye Drops | Placebo comparator | Drug: placebo eye dropsPlacebo Eye Drops |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically diagnosed with bacterial conjunctivitis
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gatifloxacin 0.5% eye dropsDay 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily | Drug | Gatifloxacin 0.5% Eye Drops |
| placebo eye dropsDay 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily | Drug | Placebo Eye Drops |
Primary outcome
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
Time frame: 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 at 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).
3 secondary outcomes
Percentage of Patients With Microbiological Cure at Day 6
Time frame: Day 6
Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6
Time frame: Day 6
Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6
Time frame: Day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25244402Heller 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.
Related trials for Bacterial Conjunctivitis
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
RecruitingPhase 1/2
Safety and Efficacy of SUM-191 for Patients With Bacterial Conjunctivitis
Bacterial Conjunctivitis
RecruitingObservational study
Development of a Mobile Terminal-Based Intelligent Detection System for Multiple Anterior Segment Diseases of the Eye
Artifical Intelligence, Cataract
RecruitingObservational study
Proteomic and Metabolomic Lacrimal Fingerprint in Diverse Pathologies of the Ocular Surface
Dry Eye Syndrome, Infectious Keratoconjunctivitis
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gatifloxacin 0.5% eye drops in people with Bacterial Conjunctivitis, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 (time frame: Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00509873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2011.