CompletedNCT00622908Updated Mar 24, 2015Results posted

Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

A Phase 2 interventional study of ISV-403 and Vehicle in Bacterial Conjunctivitis, sponsored by Bausch & Lomb Incorporated. Completed. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2015-03-24.

Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 270
Allocation: Randomized
Ages: 1 Year and older
Sex: All

Study 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

Conditions studied

Bacterial Conjunctivitis

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Conjunctivitis, Bacterial 40

In context

Conjunctivitis, Bacterial

40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.

This study's enrollment of 270 is close to the median of 261 across 36 interventional studies indexed under Conjunctivitis, Bacterial.

Browse Conjunctivitis, Bacterial studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.

First submitted before Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Year and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 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.
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 , she must utilize reliable methods and have a negative pregnancy test.

Exclusion criteria

Exclusion Criteria:

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 to SS734 or to any of the ingredients in the study medications.
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.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 270 participants (actual)

Study arms

Experimental
ISV-403
ISV-403 0.6%
Drug: ISV-403
Placebo comparator
Vehicle
Vehicle of ISV-403
Drug: Vehicle

Interventions

DrugISV-403
0.6% TID, 5 days
Also known as: besifloxacin
DrugVehicle
Vehicle of ISV-403 TID, 5 days

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Results

Posted Aug 13, 2009

Participant flow

Study was started on 12/28/04 and last patient last visit was 6/7/05. This study took place at 35 centers in the US.

Participant flow — Overall Study
Milestone	ISV-403	Vehicle
Started	137	132
Completed	134	122
Not completed	3	10
Withdrew: Protocol violation	1	0
Withdrew: Adverse event	0	1
Withdrew: Lack of efficacy	1	7
Withdrew: Lost to follow-up	1	0
Withdrew: Refusal	0	1
Withdrew: Termination by study sponser	0	1

Outcome measures

PrimaryClinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)

Resolution of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.

Time frame:: Visit 3 - day 8 or 9
Reported as:: Number · Participants

Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)
Participants	ISV-403	Vehicle
Clinical Resolution of Baseline Bacterial Conjunctivitis (Day 8 or 9)	37	20

PrimaryEradication of Baseline Pathogens (Day 8 or 9)

Bacterial species eradication of baseline bacterial infection

Time frame:: Visit 3 - Day 8 or day 9
Reported as:: Number · Participants

Eradication of Baseline Pathogens (Day 8 or 9)
Participants	ISV-403	Vehicle
Eradication of Baseline Pathogens (Day 8 or 9)	54	38

SecondaryClinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)

The absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection.

Time frame:: Visit 2 - Day 4 (+/- 1 day)
Reported as:: Number · Participants

Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)
Participants	ISV-403	Vehicle
Clinical Resolution of Baseline Bacterial Conjunctivitis Day 4 (+/- 1 Day)	14	8

SecondaryEradication of Baseline Pathogens Day 4 (+/- 1 Day)

Bacterial species eradication of baseline bacterial infection

Time frame:: Visit 2 - Day 4 (+/- 1 day)
Reported as:: Number · Participants

Eradication of Baseline Pathogens Day 4 (+/- 1 Day)
Participants	ISV-403	Vehicle
Eradication of Baseline Pathogens Day 4 (+/- 1 Day)	54	28

Adverse events

Collected over Treated period was 5 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
ISV-403	—	1/137 (0.7%)	45/137 (32.8%)
Vehicle	—	1/132 (0.8%)	46/132 (34.8%)

Most frequent serious events

Most frequent serious events
Event	ISV-403	Vehicle
Loss of ConsciousnessNervous system disorders	1/137	1/132

Most frequent other events

Most frequent other events
Event	ISV-403	Vehicle
Eye IrritationEye disorders	11/137	16/132
Eye PainEye disorders	16/137	8/132
Blurred VisionEye disorders	15/137	13/132
Eye PruritisEye disorders	3/137	9/132

Baseline characteristics

Age, Continuous
Age, Continuous(years)	ISV-403	Vehicle	Total
Mean	33.3 ± 22.3	35.1 ± 22.4	34.2 ± 22.3

Age, Customized
Age, Customized(Participants)	ISV-403	Vehicle	Total
< 2 years	2	1	3
2 to 19 Years	44	37	81
20 to 59 Years	71	71	142
>/=60 Years	20	23	43

Sex: Female, Male
Sex: Female, Male(Participants)	ISV-403	Vehicle	Total
Female	86	76	162
Male	51	56	107

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	ISV-403	Vehicle	Total
Caucasian	116	106	222
Asian	2	2	4
Black or African American	6	11	17
Hispanic	12	8	20
Other	1	5	6

Study locations

No study locations are listed for this record.

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00622908
Lead sponsor: Bausch & Lomb Incorporated
Responsible party: Sponsor
First posted: Feb 25, 2008
Start date: Dec 2004
Primary completion: Jun 2005
Completion: Jun 2005
Results posted: Aug 13, 2009
Last update: Mar 24, 2015

Study contacts

Timothy Comstock, OD

study director · Bausch & Lomb Incorporated

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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