Health Condition 1: Z984- Cataract extraction status Health Condition 2: null- eligible to undergo bilateral cataract extraction
Conditions
Interventions
Intervention1: SPIL1506 Ophthalmic suspension: SPIL1506 manufactured by Sun Pharmaceutical Industries Limited,India
Control Intervention1: Reference1506 Ophthalmic suspension: Reference product1506 ma
Sponsors
Sun Pharmaceutical Industries Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Willing and able to provide written informed consent prior to any study procedures being performed. 2. Ready and able to follow all instructions and attend all study visits. 3.Have planned bilateral cataract extraction 4. Agree to perform pregnancy test before participation in the trial 5.Agree to use an acceptable method of contraception for the duration of the study or not be of childbearing potential.
Exclusion criteria
Exclusion criteria: 1.Have any active ocular disease in either eye that requires prescription treatment 2.Have an active infection (bacterial, viral or fungal) of either eye or eyelids 3.Pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test. 4.use of an investigational drug or device within 30 days of Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Pharmacokinetic parameter :(AUC0-6) and CmaxTimepoint: 1.Pharmacokinetic parameter : over a period of approximately 7 to 63 days | — |
Secondary
| Measure | Time frame |
|---|---|
| NoneTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Limited
Outcome results
None listed