Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxac… (NCT03696342) | Clinical Trial Compass
TerminatedPhase 3
Efficacy of the Ophthalmic Pazufloxacin 0.6% for Bacterial Conjunctivitis, Compared to Gatifloxacin 0.3%.
Stopped: Sponsor's convenience
Mexico46 participantsStarted 2018-10-01
Plain-language summary
Phase III clinical study of non-inferiority, multicenter, double-blind, with comparative group, of parallel groups and randomized. about a ophthalmic topical antibiotic for the treatment of bacterial conjunctivitis.
Goal:To compare the efficacy of the ophthalmic solution of pazufloxacin 0.6%, against the ophthalmic solution of gatifloxacin 0.3%, in the treatment of acute bacterial conjunctivitis.
Hypothesis:the ophthalmic solution PRO-157 is not inferior in the treatment of bacterial conjunctivitis, compared to the ophthalmic solution of gatifloxacin 0.3%, by means of the clinical remission of the disease.
Number of patients:
160 patients, each one will provide an eye for efficacy analysis, divided into 2 groups (80 eyes per group).
Who can participate
Age range
1 Year – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed informed consent.
* Age ≥ 1 year.
* Both genders.
* Clinical picture of acute bacterial conjunctivitis defined by: Conjunctival secretion and conjunctival bulbar hyperemia
Exclusion Criteria:
* Pregnant women, lactating or planning to become pregnant.
* Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
* Participation in another clinical research study ≤ 30 days before the baseline visit.
* Previous participation in this same study.
* That they can not comply with their attendance at appointments or with all the requirements of the protocol.
* Single eye
* Presence of corneal abrasion or corneal ulceration in the study eye.
* History Users of contact lenses who are not willing to suspend their use during the study.
* Users of any formulation with ophthalmic application, including lubricants, that can not, or do not want to suspend it during the study.
* Antecedents of eye surgery 6 weeks prior to study entry.
* Viral or allergic conjunctivitis.
* Active uveitis.
* Active ulcerative keratitis.
* Recurrent corneal erosion syndrome
* Antecedent of hypersensitivity or allergy to fluoroquinolones.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Amount of Conjunctival Secretion Present in Each Patient by the End of Treatment
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)
2
Severeness of Conjunctival Bulbar Hyperemia in Each Patient by the End of Treatment
Timeframe: will be evaluated at the end of the treatment (day 8, final visit)