PK of TobraDex is compared with Tobramycin 0.3% And Dexamethasone 0.1%(Study drug) W/V In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery.
- Conditions
- Health Condition 1: null- Bilateral Cataract
- Registration Number
- CTRI/2010/091/001243
- Lead Sponsor
- Zumanta Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
a.Be male or female 18 to 55 years of age, both ages inclusive.
b.Presence of cataract in both the eyes and indicated for extracapsular cataract extraction.
c.Patients with LCOS III classification.
d.Be in the weight range as per Life Insurance Corporation of India, Underwriting Charts & Summary of Rules (As on 30-1-93), II UNDERWEIGHT AND OVERWEIGHT MIN & MAX CHART. (Refer Appendix- 4). Patients weighing less than 50 kg will not be enrolled.
e.Be able to communicate effectively with the study personnel.
f.Be a non consumer (user) of tobacco (not consumed tobacco in the past 6 months) or a mild or moderate consumer (user) of tobacco.
g.Have no evidence of underlying active disease during screening medical history and whose physical examination is performed within 21 days prior to check in.
h.Be medically fit with clinically acceptable laboratory profiles, ECG (performed within 21 days prior to check-in) and chest X-ray (performed within 6 months prior to check-in).
i.Have given the written informed consent for participation in the study.
j.Be declared eligible to participate in the study by the investigator (s).
k. In addition, female patients selected for the study must:
i)Be using a medically acceptable form of birth control (such as foams, jellies, diaphragm, intra-uterine device (IUD) or abstinence) for the duration of the study as judged by the investigator(s) Or
ii)Be sterilized by surgical methods (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy) at least 6 months back
Or
iii)Have attained menopause at least 1 year back.
iv)And have a negative urine pregnancy test prior to check-in to the clinical facility
Exclusion Criteria
Any of the following conditions are cause for exclusion from the study:
a.Participation in any bioavailability/bioequivalence/Pharmacokinetic study or received an investigational drug within a period of 3 months prior to check in.
b.Presence or history of epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella of the cornea and conjunctiva.
c.History of ?recent (last 15 days)? or ?active? viral diseases of the cornea and conjunctiva.
d.Presence or history of uveitis or uveitis within the previous 12 months, or laser-assisted in-situ keratomileusis, photorefractive, keratectomy, radial keratotomy, or similar surgery in the previous 3 months.
e.Ocular trauma within 3 months of the trial, active external ocular disease, inflammation, or infection (mycobacterial or fungal disease) of the study eye and corneal diseases or disruption.
f.Patients who had received dexamethasone or beclamethasone within 7 days of check in.
g.Presence of uncontrolled diabetes.
h.History of drug abuse, or alcohol dependence or abuse.
i.History of any allergies (asthma, urticaria) including drug allergies.
j.Known hypersensitivity or allergy to TobraDex® in combination or its components.
k.Severe consumer (user) of tobacco.
l.Presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, hepatic, immunologic, hematological, endocrine, or nervous system(s) or psychiatric disease or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the patient at increased risk, as determined by the investigator(s).
m.Patients who have:
i.Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician /investigator (s).
ii.Pulse rate below 60 per minute or above 100 per minute.
iii.Respiratory rate below 15 or above 20 breaths per minute.
iv.Oral temperature less than 96.2oF or more than 99.8oF.
n.Clinical laboratory test values outside the acceptable reference range and when confirmed on re-examination deemed to be clinically significant.
o. Positive screening results for Hepatitis B, Hepatitis C, HIV or Syphilis.
p.Clinically significant illness during the 4 weeks prior to check-in (as determined by the investigators).
q.Change in existing prescription drug(s) for systemic action in the 14 days prior to check-in or OTC drug in the 14 days since last visit.
r.Positive result in breath analysis test for alcohol.
s.Positive urine drug screening results for any of the following: cocaine, THC, barbiturates, amphetamines, benzodiazepines, and morphine.
t.Positive test for pregnancy for female patients
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax Tmax, AUCt,Bacterial Kill rateTimepoint: 8 patients (2 patients per time point) will be randomly assigned to aqueous humor sample time points at 0.5, 3.0, 5.0 and 8.0. <br/ ><br> <br/ ><br>16 patients (4 patients per time point) will be randomly assigned to aqueous humor sample time points at 1.0, 1.5, 2.0 and 2.5.
- Secondary Outcome Measures
Name Time Method toxicity, Safety, TolerabilityTimepoint: none