Bacterial ConjunctivitisPhase 2NCT00622908

Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

A Phase 2 study testing ISV-403 in people with Bacterial Conjunctivitis, run by Bausch & Lomb Incorporated.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the clinical and microbial efficacy of ISV-403 administered three times a day (TID) for 5 days compared to vehicle three times a day for 5 days in the treatment of 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?: ISV-403
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 270 participants
Where: No sites listed yet
Study dates: Dec 2004to Jun 2005
Phase: Phase 2
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

Must be at least one year of age.
Must have signature of subject or legally authorized representative (if subject is under 18 years of age) on the informed Consent Form.
Must have signature of subject on the Assent Form if subject is 6 to 17 years of age.
Must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for either bulbar or palpebral conjunctival injection.
Must have pinholed visual acuity equal to or better than 20/200 in both eyes. Age appropriate visual acuity testing was to be performed. Every effort was made to obtain a visual acuity measurement in children. If visual acuity was unobtainable in children, it was at the investigator's discretion to meet inclusion criteria.
Must be willing to discontinue contact lens wear for the duration of the study.

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Must be willing to avoid disallowed medications during the study period.
Must understand the scope of the study including completion of diary, be willing to follow instructions, and be able to make all required study visits.
If a subject was a female of childbearing potential, she must utilize reliable contraceptive methods and have a negative pregnancy test.

Who cannot join

Any uncontrolled systemic disease or debilitating disease.
Use of topical ophthalmic solutions including tear substitutes within two hours before and during the study.
Use of any ophthalmic topical anti-inflammatory agents within 48 hours before and during the study.
Subjects likely to require antimicrobial therapy with any active respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media.
Pregnant or nursing females.
Known hypersensitivity to SS734 or to any of the ingredients in the study medications.

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Known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medications.
Ocular surgery (including laser surgery) in either eye within the past six weeks.
Subjects with suspected viral or allergic conjunctivitis (i.e., severe itching or acute follicular conjunctivitis), or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
Subjects with suspected iritis (i.e., smaller pupil, pain, and photophobia in infected eye).
History of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
Use of any antibiotic within 72 hours of enrollment.
Any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis
Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study.
Subjects who were immune compromised.

About this study

Official title: A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis

Conditions: Bacterial Conjunctivitis
Being tested: ISV-403, Vehicle
Medical subject headings: Conjunctivitis, Bacterial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ISV-403Drug
Also called besifloxacin
0.6% TID, 5 days
VehicleDrug
Vehicle of ISV-403 TID, 5 days

Study groups in NCT00622908
Study group	Role	What they receive
ISV-403	Experimental	ISV-403 0.6% Receives: Drug: ISV-403
Vehicle	Placebo comparator	Vehicle of ISV-403 Receives: Drug: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)
Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Measured: Visit 3 - day 8 or 9
Eradication of Baseline Pathogens (Day 8 or 9)
Bacterial species eradication of baseline bacterial infection
Measured: Visit 3 - Day 8 or day 9

Secondary outcomes (2)

Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)
The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Measured: Visit 2 - Day 4 (+/- 1 day)
Eradication of Baseline Pathogens Day 4 (+/- 1 Day)
Bacterial species eradication of baseline bacterial infection
Measured: Visit 2 - Day 4 (+/- 1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2004Jun 2005

First posted25 Feb 2008 (estimated)
Study startDec 2004
Primary completionJun 2005
Study completionJun 2005

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 (3)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00622908
Sponsor's protocol ID: 373
Status last verified: Mar 2015
First submitted: 14 Feb 2008
Last updated: 24 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020.
PubMed 32841261
Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000.
PubMed 20629472
Karpecki P, Depaolis M, Hunter JA, White EM, Rigel L, Brunner LS, Usner DW, Paterno MR, Comstock TL. Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study. Clin Ther. 2009 Mar;31(3):514-26. doi: 10.1016/j.clinthera.2009.03.010.
PubMed 19393842

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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

All Bacterial Conjunctivitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Clinical and Microbial Efficacy of 0.6% ISV-403 Compared to Vehicle in the Treatment of Bacterial Conjunctivitis
ClinicalTrials.gov ID: NCT00622908
Acronym / sponsor ID: 373
Conditions: Bacterial Conjunctivitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Dec 2004
Primary completion: Jun 2005 (actual)
Study completion: Jun 2005 (actual)
First posted: 25 Feb 2008 (estimated)
Results: Posted 13 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ISV-403	Experimental	Drug: ISV-403ISV-403 0.6%
Vehicle	Placebo comparator	Drug: VehicleVehicle of ISV-403

Who may qualify

Ages: 1 year and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Must be at least one year of age.
Must have signature of subject or legally authorized representative (if subject is under 18 years of age) on the informed Consent Form.
Must have signature of subject on the Assent Form if subject is 6 to 17 years of age.
Must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for either bulbar or palpebral conjunctival injection.
Must have pinholed visual acuity equal to or better than 20/200 in both eyes. Age appropriate visual acuity testing was to be performed. Every effort was made to obtain a visual acuity measurement in children. If visual acuity was unobtainable in children, it was at the investigator's discretion to meet inclusion criteria.

Key exclusion criteria (15 listed)

Any uncontrolled systemic disease or debilitating disease.
Use of topical ophthalmic solutions including tear substitutes within two hours before and during the study.
Use of any ophthalmic topical anti-inflammatory agents within 48 hours before and during the study.
Subjects likely to require antimicrobial therapy with any active respiratory tract infection, urinary tract infection, skin/soft tissue infection, or otitis media.
Pregnant or nursing females.

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
ISV-403Also: besifloxacin0.6% TID, 5 days	Drug	ISV-403
VehicleVehicle of ISV-403 TID, 5 days	Drug	Vehicle

Primary outcome

Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)
Time frame: Visit 3 - day 8 or 9
Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.
Eradication of Baseline Pathogens (Day 8 or 9)
Time frame: Visit 3 - Day 8 or day 9
Bacterial species eradication of baseline bacterial infection

2 secondary outcomes

Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)
Time frame: Visit 2 - Day 4 (+/- 1 day)
Eradication of Baseline Pathogens Day 4 (+/- 1 Day)
Time frame: Visit 2 - Day 4 (+/- 1 day)

Results and safety

Results posted to the registry on 13 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ISV-403	137	134
Vehicle	132	122

Primary outcome: Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)

Time frame: Visit 3 - day 8 or 9. Number. Unit: Participants

Measure	ISV-403 n = 60	Vehicle n = 56
Value	37	20

Population analysed: Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.

Primary outcome: Eradication of Baseline Pathogens (Day 8 or 9)

Time frame: Visit 3 - Day 8 or day 9. Number. Unit: Participants

Measure	ISV-403 n = 60	Vehicle n = 55
Value	54	38

Population analysed: Intent to treat population, culture confirmed. Missing values and discontinued patients imputed as failures.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treated period was 5 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ISV-403	1 of 137 (0.7%)	45 of 137 (32.8%)	Not reported
Vehicle	1 of 132 (0.8%)	46 of 132 (34.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32841261DeCory HH, Sanfilippo CM, Proskin HM, Blondeau JM. Characterization of baseline polybacterial versus monobacterial infections in three randomized controlled bacterial conjunctivitis trials and microbial outcomes with besifloxacin ophthalmic suspension 0.6. PLoS One. 2020 Aug 25;15(8):e0237603. doi: 10.1371/journal.pone.0237603. eCollection 2020.
Derived from this study: PubMed 20629472Comstock TL, Paterno MR, Decory HH, Usner DW. Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies. Clin Drug Investig. 2010;30(10):675-85. doi: 10.2165/11536720-000000000-00000.
Derived from this study: PubMed 19393842Karpecki P, Depaolis M, Hunter JA, White EM, Rigel L, Brunner LS, Usner DW, Paterno MR, Comstock TL. Besifloxacin ophthalmic suspension 0.6% in patients with bacterial conjunctivitis: A multicenter, prospective, randomized, double-masked, vehicle-controlled, 5-day efficacy and safety study. Clin Ther. 2009 Mar;31(3):514-26. doi: 10.1016/j.clinthera.2009.03.010.

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.

Timothy Comstock, OD study director

Bausch & Lomb Incorporated

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ISV-403 in people with Bacterial Conjunctivitis, run by Bausch & Lomb Incorporated.

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 9 inclusion and 15 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 13 Aug 2009). 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?

Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9) (time frame: Visit 3 - day 8 or 9). The study lists 2 primary outcomes in all. 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 NCT00622908, which also lists 3 linked publications.

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 24 Mar 2015.