Health Condition 1: H160- Corneal ulcer
Conditions
Interventions
Intervention1: PT and rifampin ophthalmic solution containing polymyxin B, trimethoprim and Rifampin (10,000 units polymyxin B, 1 mg per ml trimethoprim, and 0.5 mg per ml rifampin): 1 drop in the stu
Sponsors
L V Prasad Eye Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects have given written informed consent to participate in the study 2.Subject has a clinical diagnosis of suspected bacterial keratitis in one eye only (study eye) defined as an ulceration of the epithelium characterized by fluorescein staining with focal or diffuse suppurative stromal inflammation, cellular infiltration in the adjacent stroma with or without anterior chamber cellular reaction 3.If subject is a female of childbearing potential, she must utilize a reliable contraceptive method [chemical contraceptive (oral, implantable, or injectable), spermicide with barrier, or IUD] throughout the study, and must have a negative urine pregnancy test prior to enrollment in this study 4.Subject is 18 years of age or older 5.Subject understands the scope of the study and is willing to follow instructions and able to make all required study visits 6.Subjects has best-corrected visual acuity (ETDRS) of +1.0 logMAR (Snellen equivalent 20/200) or better in the fellow eye
Exclusion criteria
Exclusion criteria: 1.Presence of suspected fungal, viral, or parasitic ocular infection in the study eye. 2.A significant thinning ( >50%) of corneal stroma. 3.Females who are lactating, pregnant or are planning a pregnancy, or females of childbearing potential not using a reliable method of contraception. 4.Contact lens wear in the study eye during study period. 5.Use of any topical non-ocular or systemic antimicrobial (including subconjunctival injections) or steroid within 24 hours prior to enrollment into the study or during the study. 6.Use of topical ocular antimicrobial or steroid solution in the study eye within 2 hours prior to enrollment into the study or during the study. Patients should not have been on other pre-study antimicrobial therapy for corneal ulcers for >24 hours. 7.Subject with suspected bacterial endophthalmitis or bacterial scleritis. 8.Use of any systemic/topical investigational drug or device during the study or within 30 days before receipt of study medication. Patients cannot have previously been enrolled in this study. 9.Ocular surgery in the study eye within six weeks before the beginning of the study. 10.Cardiovascular or respiratory surgery within six weeks before the beginning of the study. 11.History of allergy or sensitivity to polymyxin B, trimethoprim, rifamycin or any component of the study medications, including the preservative BAK. 12.Current alcohol and/or drug abuse. 13.History of retinal detachment, diabetic retinopathy, or any retinal disease which may be progressive during the study. 14.Any history of uncontrolled chronic systemic disease (e.g., cardiovascular disease, hypertension, or diabetes). 15.Any history of autoimmune disease that the investigator feels may interfere with the study parameters (e.g., acquired immune-deficiency syndrome or rheumatoid arthritis). 16.Any abnormality or presence of any significant illness that could interfere with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable is clinical cure (i.e., complete re-epithelialization of the infected cornea and no progression from baseline of the stromal infiltrate) at the clinical Cure Visit (Endpoint) with confirmation at the Confirmatory Visit.Timepoint: Day 1, day 2 or 3, Day 5, 8,12, 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (BCVA) Cure rate at selected timepoints Cure rate at Endpoint by baseline epithelial defect size Time to Clinical Cure Treatment failures Adverse events & other therapeutic side effects Relapse of cure Cure rate based on organism Timepoint: Visit 1 (Day 0), Visit 2 (Day 1,2,3) Visit 3-8 (Days 4-19) Confirmatory Visit/End of Trial (Day 3 2 of Post Clinical Cure Visit) | — |
Countries
India
Contacts
Public ContactDr. Bhupesh Bagga
L V Prasad Eye Institute
Outcome results
None listed