Clinical study of SPIL1506 and reference1506 in subjects with indication of Bilateral Cataract Surgery

Not yet recruiting

• Conditions: Cataract extraction status, eligible to undergo bilateral cataract extraction ,

• Registration Number: CTRI/2017/08/009210
• Lead Sponsor: Sun Pharmaceutical Industries Ltd

Brief Summary

This is open label Bioequivalence study.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-09
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 418

Inclusion Criteria

• 1.Willing and able to provide written informed consent prior to any study procedures being performed.
• 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

• 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
1.Pharmacokinetic parameter :(AUC0-6) and Cmax	1.Pharmacokinetic parameter : over a period of approximately 7 to 63 days

Trial Locations

Locations (17)

Aster Aadhar Hospital (Prerana Hospital Ltd.); 🇮🇳 Kolhapur, MAHARASHTRA, India

Bhaktivedanta Hospital & Research Institute; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. B. R. Ambedkar Medical College; 🇮🇳 Bangalore, KARNATAKA, India

G.S.V.M Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

GCS Medical College, Hospital & Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

KLES Dr. Prabhakar Kore Hospital and Medical Research Centre; 🇮🇳 Belgaum, KARNATAKA, India

Mahatme Eye Bank & Eye Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Meditrina Institute of Medical Sciences; 🇮🇳 Nagpur, MAHARASHTRA, India

Mysore Medical College and Research Institute and Associated Hospitals; 🇮🇳 Mysore, KARNATAKA, India

New Vision Laser Center Pvt. Ltd.; 🇮🇳 Vadodara, GUJARAT, India

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Aster Aadhar Hospital (Prerana Hospital Ltd.)

🇮🇳Kolhapur, MAHARASHTRA, India

Dr Sujata Navare

Principal investigator

9225068511

sujatanavare.aacr@gmail.com