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CTRI Number  CTRI/2024/08/071785 [Registered on: 01/08/2024] Trial Registered Prospectively
Last Modified On: 26/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Phase III clinical study evaluates the efficacy and safety of a combination eye drop containing Moxifloxacin/Nepafenac compared to Moxifloxacin/Ketorolac for patients with Inflammatory Ocular Conditions 
Scientific Title of Study   A Multicentre Randomized, Double Blind Parallel Group Active Controlled Comparative Phase three Clinical Study to Evaluate the Efficacy and Safety of FDC Moxifloxacin 0.5 percent weight by volume plus Nepafenac 0.1 percent weight by volume eye drop with FDC of Moxifloxacin 0.5 percent weight by volume plus Ketorolac 0.5 percent weight by volume eye drop in Adult Patient Suffering From Inflammatory Ocular Conditions Where Bacterial Infection or a Risk of Bacterial Ocular Infection exist 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
BRPL/CT/FDC/MOXNEP/01/23 version 01 Dated 27 Jan 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditi Datta  
Designation  Managing Director  
Affiliation  Biosite Research Private Limited.  
Address  1st Floor, Ajmera Nucleus, 424C, Next to Mahindra Tech Park, Shanthipura, Electronic City Phase 2, Bengaluru,

Bangalore
KARNATAKA
560100
India 
Phone  9811788955  
Fax    
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditi Datta  
Designation  Managing Director  
Affiliation  Biosite Research Private Limited.  
Address  1st Floor, Ajmera Nucleus, 424C, Next to Mahindra Tech Park, Shanthipura, Electronic City Phase 2, Bengaluru,

Bangalore
KARNATAKA
560100
India 
Phone  9811788955  
Fax    
Email  aditi.datta@biositeindia.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditi Datta  
Designation  Managing Director  
Affiliation  Biosite Research Private Limited.  
Address  1st Floor, Ajmera Nucleus, 424C, Next to Mahindra Tech Park, Shanthipura, Electronic City Phase 2, Bengaluru.

Bangalore
KARNATAKA
560100
India 
Phone  9811788955  
Fax    
Email  aditi.datta@biositeindia.com  
 
Source of Monetary or Material Support  
Akums Drugs & Pharmaceuticals Limited Plot No 2 3 4 5 Sector 6B IIE SIDCUL Ranipur Haridwar Uttarakhand 249403 
 
Primary Sponsor  
Name  Akums Drugs & Pharmaceuticals Limited  
Address  MS Akums Drug and Pharmaceutical Ltd Plot No 2 3 4 5 Sector 6B IIE SIDCUL Ranipur Haridwar Uttarakhand 249403 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bivas Bala  Calcutta National Medical College & Hospital   32, Gorachand Road, Kolkata-700014 Department of Ophthalmology, 2nd floor, Dr. Bivas Balas room
Kolkata
WEST BENGAL 		 9475136474

bivasbala@gmail.com 
Dr Parul Singh  Department of Ophthalmology, GSVM Medical College  Ward no 11, Department of Ophthalmology, GSVM Medical College, Swaroop Nagar, Kanpur 208002
Kanpur Nagar
UTTAR PRADESH 		 8009537183

parulsingh1406@gmail.com 
Dr T Jyothirmai  Government Medical College & Government General Hospital (Old RIMSGGH)  OPD no 11, 1st Floor, Department of Ophthalmology, 532001
Srikakulam
ANDHRA PRADESH 		 9848458225

drjyothirmai.ggh@gmail.com 
Dr Miral Prajapati  Kanoria Hospital and Research Centre  Ground Floor, Gandhinagar Highway, Bhat, Gandhinagar 382428,
Gandhinagar
GUJARAT 		 7016299035

drmiralprajapati1994@gmail.com 
Dr Ashok Kumar Nanda  Kar Vision Eye Hospital   Plot no 10, 3rd Floor, Janpath Rd, Satya Nagar, Bhubaneswar, Odisha 751007
Khordha
ORISSA 		 9337268507

ashoknanda@hotmail.com 
Dr Shubhratha Sathish Hegde  KR Hospital   Department of Ophthalmology, Groundfloor Irwin Road, Mysore- 570001, Karnataka, India
Mysore
KARNATAKA 		 9900566118

drshubhratha@gmail.com 
Dr Rajesh Parekh  Sanjeevani Netralaya Medical Research Centre  #141,Room no 101, Ground floor, Bhagwan Mahaveer (Infantry Road) Opposite to The Hindu, Bangalore - 560001
Bangalore
KARNATAKA 		 9945544744

vision6by6@gmail.com 
Dr Poonam Vinayak Pawar  Signus Hospital  Room no 04 Clinical research department,5th floor, Atlanta shoppers, pathardi phata, pathardi road, Nashik-422010, Maharashtra, India
Nashik
MAHARASHTRA 		 9172829142

drpoonampawar123@gmail.com 
Dr Abhishek Vajpeyi  Tulsi Hospital   14/116, Room no 21, A Civil Lines, Kanpur - 208001
Kanpur Nagar
UTTAR PRADESH 		 9415538533

adityaeyecarekanpur@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
CUTM Independent Ethics committee   Approved 
Ethics Committee GSVM Medical College  Approved 
Gurushree Hitech Multispeciality hospital   Approved 
Institutional Ethics Committee Government Medical College and Government General Hospital Old RIMSGGH  Approved 
Institutional Ethics Committee Signus Hospital  Submittted/Under Review 
Kanoria Ethics Committee  Submittted/Under Review 
Maharaja Agrasen Hospital Institutional Ethics Committee,  Approved 
Mysore Medical College & Research institute   Submittted/Under Review 
Signus Hospital Ethics Committee  Submittted/Under Review 
Tulsi Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H16||Keratitis, (2) ICD-10 Condition: H200||Acute and subacute iridocyclitis, (3) ICD-10 Condition: H150||Scleritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  FDC Moxifloxacin 0.5% w/v + Nepafenac 0.1% w/v eye drop  The dose is one drop in the target eye four times a day for 7 days of treatment duration. 
Comparator Agent  FDC of Moxifloxacin 0.5% w/v + Ketorolac 0.5% w/v eye drop  The dose is one drop in the target eye four times a day for 7 days of treatment duration. 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  1. Adult male and female subjects, 18 years to 60 years of age (both inclusive).
2. Patients with current inflammatory eye disease (i.e., uveitis, scleritis, keratitis) in either eye as diagnosed using slit lamp Biomicroscopy.
3. Patients with ocular inflammation including who have undergone cataract surgery, vitreous surgery or both (including patients who have undergone IOL insertion surgery).
4. Patients with Anterior chamber cell grade ≥ 1+ based on Standardization of Uveitis Nomenclature (SUN) criteria.
5. Patients with Intraocular Pressure (IOP ≦ 20 mmHg).
6. Patients who are able to understand and give voluntary, written informed consent to participate in this clinical investigation and from whom written consent has been obtained.
7. Patients shall be willing and able to understand and comply with the requirements of the study, administer the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
8. Female Patients, of child-bearing potential practicing an acceptable method of birth control such as sexual abstinence, intrauterine device IUD, birth control pills, a double-barrier method, transdermal, injection or implants, non-hormonal or hormonal, condom plus spermicide, diaphragm plus spermicide, or vaginal spermicidal suppository; for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same should be used during treatment.
OR
Postmenopausal for at least 1 year
OR
Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject). 
 
ExclusionCriteria 
Details  1. Documented/suspected history of hypersensitivity to the study medications or any of the ingredients of the formulation.
2. Patients who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the drugs.
3. Patients who underwent local injection of corticosteroids in the eyes before instillation of the investigational drugs; (patients who used aqueous preparations within 1 week or patient who used depot preparations within 2 weeks will be excluded)
4. Patients with summed ocular inflammation score
5. Patients who took systemic administration of non-steroidal anti-inflammatory agents or anti-inflammatory enzyme preparations within 3 days before instillation of the investigational drugs.
6. Patients who instilled non-steroidal anti-inflammatory agents within 24 hours before the screening period.
7. Patients who underwent sub-conjunctival or intravitreal injection.
8. Patients who have intraocular hemorrhage with a degree that may affect the postoperative evaluations.
9. Patients who underwent gas tamponade at the surgery.
10. Patients with endogenous uveitis.
11. Patients having corneal epithelial detachment or corneal ulcer in the target eye.
12. Patients who are required to wear contact lens during the study period.
13. Patients who are scheduled to undergo surgery of the opposite eye during the study period.
14. Patients with Concurrent use of any topical ophthalmic medications other than the study intervention during the course of the study.
15. Patients with Concurrent use of temporary or permanent punctual plugs or history of punctual cautery in one or both eyes.
16. Patients with Current enrolment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
17. Patients with participation in a blood or plasma donation program within 30 days prior to the study intervention administration.
18. Patients with severe dry eye disease.
19. Subjects with Covid 19 signs and symptoms during screening will be excluded in the study.
20. Females who are pregnant, nursing or planning a pregnancy during the study.
21. Patients with documented history of clinically significant or progressive retinal disease (e.g., retinal degeneration, diabetic retinopathy, retinal detachment) in either eye.
22. Patients with documented history of ocular trauma ≤ 6 months before the study.
23. Patients with severe illness or other condition that would make the patient unsuitable for the study, as per investigator discretion.
24. Patients with active or prior severe, unstable, or uncontrolled cardiovascular, cerebrovascular, hepatic, or renal disease.
25. Patients with clinically significant impaired hepatic function (SGOT and SGPT more than 3X the UNL and/or Total bilirubin more than 2 X the UNL) at screening.
26. Currently taking prohibited concomitant medications(s) like local or systemic Corticosteroids, Anti-vascular endothelial growth factor (anti-VEGF) therapy and inability/unwillingness to discontinue them for the entire study period.
27. Patients who are known seropositive cases of HIV, Hepatitis B or Hepatitis C.
28. Patients who have a recent history or who are currently known to abuse alcohol or drugs.
29. Suspected inability or unwillingness to comply with the protocol or other study procedures. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients showing improvement in ocular inflammation using slit lamp biomicroscopy   From baseline Visit 2 and day 7. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Evaluate the percentage of patients with symptoms of ocular inflammation which includes pain, photophobia & watering at Day 1, 3 & 7.

2.Percentage of patients showing improvement in aqueous flare using slit lamp biomicroscopy using Standardization of Uveitis Nomenclature (SUN) criteria from baseline & day 7.

3.Percentage of patients showing improvement in Conjunctival Hyperemia from baseline to Day 3 & Day 7. 		 1. At Day 1, 3 & 7.
2. From baseline & day
3. From baseline to Day 3 & Day 7. 
 
Target Sample Size   Total Sample Size="258"
Sample Size from India="258" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A Clinical Study to Evaluate the Efficacy and Safety of FDC Moxifloxacin 0.5% w/v + Nepafenac 0.1% w/v eye drop with FDC of Moxifloxacin 0.5% w/v + Ketorolac 0.5% w/v eye drop in Adult Patient Suffering From Inflammatory Ocular Conditions. The Drug efficacy and safety will be checking with total 258 Uveitis patients. and subjects will be randomized into 1:1 Ratio i.e., Test Drug is FDC Moxifloxacin 0.5% w/v + Nepafenac 0.1% w/v Ophthalmic Suspension and the Comparator Drug is FDC of Moxifloxacin 0.5% w/v + Ketorolac 0.5% w/v eye drop and Total study duration shall be around 9 days which includes 7 days of Treatment period and 2 days of Screening period. 
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