Health Condition 1: null- Cataract in atleast one eye indicated for extracapsular cataract extraction/phacoemulsification
Conditions
Interventions
Intervention1: Loteprednol etabonate suspension 0.5 %: A single dose (100
μL or two drops) of
the test product will
be instilled by a
sterile calibrated
micropipette into
the inferior cul-desac
of th
Sponsors
Watson Pharma Pvt Ltd India
Eligibility
Inclusion criteria
Inclusion criteria: 1. male or female 18 to 75 years of age, both ages inclusive 2. Have presence of cataract in at least one eye indicated for extracapsular cataract extraction/phacoemulsification. 3. Be patients with The Lens Opacities Classification System III (LOCS III classification). 4. Body Mass Index between 18.0 and 30.0 kg/m2 5. Be able to communicate effectively with the study personnel. 6. Be a non-consumer (user) of tobacco (not consumed tobacco in the past 6 months) or a mild or moderate consumer (user) of tobacco. 7. Should have undergone medical screening. 8. Have given the written informed consent for participation in the study. 9. Be declared eligible to participate in the study by the investigator (s).
Exclusion criteria
Exclusion criteria: 1. Participation in a drug research study within past 3 months. 2. Presence or history of epithelial herpes simplex keratitis, vaccinia, varicella of the cornea and conjunctiva. 3. Recent or active viral diseases of the cornea and conjunctiva. 4. Presence or history of uveitis or uveitis within the previous 12 months. 5. Ocular trauma within 3 months of the trial, active external ocular disease, inflammation, or infection 6. Received Loteprednol etabonate within 7 days of check-in. 7. Uncontrolled diabetes. 8. History of drug abuse or alcoholo dependence or abuse. 9. History of any allergies 10. Hypersensitivity to investgational product 11. Extreme consumer of tobacco 12. Presence of any clinically significant disorder. 13. Clinical laboaratory values out side the accepatble range. 14 Uncontrolled blood pressure. 15. positive screening to Hepatitis B, Hepatitis C and HIV. 16. Any clinically significant illness in past 4 weeks pror to check-in. 17. Change in existing prescription drug (s) for systemic action or OTC drug in the 14 days prior to check-in. 18. Positive urine drug screening results for any of the following: cocaine, THC, barbiturates, amphetamines, benzodiazepines, and morphine. 19 Positive test for pregnancy for female patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the pharmacokinetics of Loteprednol etabonate ophthalmic suspension containing Loteprednol etabonate 0.5 % mfg by Indoco Remedies Limited for WPPL India with that from LOTEMAX (loteprednol etabonate) Ophthalmic Suspension, 0.5 % of Bausch and Lomb Inc., in vivo in aqueous humor, after topical instillation in the inferior cul de sac of any one of the two eyes of patients undergoing indicated cataract surgery and to assess for bioequivalenceTimepoint: At the end of the study outcome will be measured for concentration of drug in aq humor from each patient | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety and tolerability of a single dose of ophthalmic sterile suspension containing Loteprednol etabonate, 0.5 % in vivo in aqueous humor, after topical instillation in the inferior cul de sac of any one of the two eyes of patients undergoing indicated cataract surgery Timepoint: At the end of the study outcome will be measured for concentration of drug in aq humor from each patient. Also safety & tolerability will be assessed. | — |
Countries
India
Contacts
Public ContactDr Sumit Arora
Lotus Labs Pvt Ltd
Outcome results
None listed