Clinical study of SPIL1506 and reference1506 in subjects with indication of Bilateral Cataract Surgery
- Conditions
- Health Condition 1: Z984- Cataract extraction statusHealth Condition 2: null- eligible to undergo bilateral cataract extraction
- Registration Number
- CTRI/2017/08/009210
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 418
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.
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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method