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CTRI Number  CTRI/2024/07/070446 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 19/02/2025
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 Comparing Combined Netarsudil and Latanoprost Eye Drops to Single Therapy for Glaucoma. 
Scientific Title of Study   A Multi-Center, Double-Blind, Randomized, Active-Controlled, Comparative, Parallel-Group, Phase III Clinical Study to Evaluate the efficacy and safety of FDC of Netarsudil and Latanoprost Ophthalmic Solution with monotherapy of Netarsudil Ophthalmic Solution and Latanoprost Ophthalmic Solution in patients with open-angle glaucoma or ocular hypertension. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
BRPL/CT/FDC/NSLP/02/21;Version: 3.0;Date: 28.01.2022  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

Bangalore
KARNATAKA
560100
India 
Phone  8035104561  
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


KARNATAKA
560100
India 
Phone  8035104561  
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


KARNATAKA
560100
India 
Phone  8035104561  
Fax    
Email  aditi.datta@biositeindia.com  
 
Source of Monetary or Material Support  
Pure and Cure Healthcare (P) Ltd 305, Mohan Place, L.S.C. Block-C, Saraswati Vihar, New Delhi_110034. 305, Mohan Place, L.S.C. Block-C, Saraswati Vihar, New Delhi_110034 
 
Primary Sponsor  
Name  MsPure And Cure Healthcare PvtLtd 
Address  Plot No.26A, 27-30,sector-8A,IIE, SIDUCL,Ranipur,Haridwar,uttrakhand-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 = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Richa Srivastava  Eye Sight Centre  Eye Sight Centre, Plot H2/1, Naria Tiraha, Varanasi - 221005
Varanasi
UTTAR PRADESH 		 8052226222

Richa_ims@yahoo.co.in 
Dr Parul Singh  GSVM Medical College  Department of Ophthalmology, GSVM Medical College, Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH 		 8009537183

parulsingh1406@gmail.com 
Dr Swati R  K R Hospital, Mysore  Department of Ophthalmology, K R Hospital attached to Mysure Medical College and Research Institute, Irwin Road, Mysore- 570001.
Mysore
KARNATAKA 		 9448787598

swatiprakash.darpan@gmail.com 
Dr Miral Prajapati  Kanoria Hospital and Research centre  Kanoria Hospital and Research centre, Airport- Gandhinagar Highway, Village- Bhat-Gujarat- 382428
Gandhinagar
GUJARAT 		 7016299035

drmiralprajapati1994@gmail.com 
Dr Rajesh Parekh  Sanjeevani Nethralaya  Sanjeevani Netralaya Medical Research Centre, #141, Bhagwan Mahaveer (Infantry Road) Opposite to The Hindu, - 560001
Bangalore
KARNATAKA 		 9945544744

vision6by6@gmail.com 
Dr Poonam Vinayak Pawar  Signus Hospital  Signus Hospital, 5th floor, Atlanta Shoppers, Pathardi Phata, - 422010
Nashik
MAHARASHTRA 		 9172829142

poonam_yogesh@rediffmail.com 
Dr Abhishek Vajpeyi  Tulsi Hospital  Tulsi Hospital India Limited,14/116 - A Civil Lines, Kanpur - 208001
Kanpur Nagar
UTTAR PRADESH 		 9415538533

adityaeyecarekanpur@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ace Independent Ethics Committee  Approved 
CUTM-Independent Ethics Committee  Approved 
Ethics Committee GSVM Medical College  Submittted/Under Review 
IEC King George hospital  Approved 
Institutional Ethics Committee Mysure Medical College and Research Institute  Submittted/Under Review 
Kanoria Ethics Committee Kanoria Hospital and Research centre  Submittted/Under Review 
Signus Hospital Ethics Committee  Submittted/Under Review 
Tulsi Hospital Ethics Committee  Submittted/Under Review 
Vatsalya Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H401||Open-angle glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparator Drug 1: Netarsudil 0.02% w/v Ophthalmic Solution  The dose is one drop of Netarsudil 0.02% w/v Ophthalmic Solution of comparator drugs in the conjunctival sac of the affected eye(s) once daily, in the evening daily for 12 weeks 
Comparator Agent  Comparator Drug 2: Latanoprost 0.005% w/v Ophthalmic Solution  The dose is one drop of Latanoprost 0.005% w/v Ophthalmic Solution of comparator drugs in the conjunctival sac of the affected eye(s) once daily, in the evening daily for 12 weeks 
Intervention  Netarsudil plus Latanoprost  The dose is one drop of FDC of Netarsudil 0.02% plus Latanoprost 0.05% w/v Ophthalmic Solution of test drug in the conjunctival sac of the affected eye(s) once daily, in the evening daily for 12 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either sex aged 18 to 65 years (both inclusive)
and ready to give written informed consent to participate
in the study.
2. Diagnosis (new/old) of primary open angle glaucoma/ocular hypertension in at least one eye confirmed by Goldmann applanation tonometry
3. IOP values a. Newly diagnosed. IOP Greater-than 20 mmHg and Less-than 36 mmHg at 9 AM in at least one eye at screening and day 1 (randomization day) b. Old patients. Unmedicated (post-washout (refer note)) IOP Greater-than 20 mmHg and Less-than 36 mmHg at 9 AM in at least one eye at day 1 (randomization day) For purposes of determining eligibility of subjects to be randomized, IOP number should not be rounded off.
4. Best corrected visual acuity Plus 1.0 logMAR or better by ETDRS in each eye (equivalent to 20 by 200 (6 by 60) or better Snellen visual acuity in each eye)
5. Patients presenting with mild or moderate severity of glaucoma (as per ICMR guidelines).
6. Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing (oral, intravaginal, or transdermal) or progesterone only (oral, injectable, or implantable) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or sexual abstinence) (Note Woman with childbearing potential are defined as those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal).
7. A female patient of non-childbearing potential such as (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. (Note Post-menopausal woman will be defined as Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age) Note Ocular Hypotensive Medication Washout Period Prostaglandin analogues- 4 weeks β-adrenoceptor antagonists- 4 weeks Adrenergic agonists (including α-agonists such as brimonidine and apraclonidine)- 2 weeks Muscarinic agonists (eg, pilocarpine), carbonic anhydrase inhibitors (topical or oral)- 5 days.
 
 
ExclusionCriteria 
Details  1.Clinically significant ocular disease (eg, corneal edema, uveitis, or severe keratoconjunctivitis sicca) which might interfere with interpretation of the study efficacy endpoints or with safety assessments, including subjects with glaucomatous damage based on field effect so severe that washout of ocular hypotensive medications for 1 month is not judged safe as it would put the subject at risk for further vision loss. (The Investigator will be encouraged to conduct interim visits (unscheduled visits) during the washout period for IOP measurements for individuals to whom a washout period may be a risk for further glaucomatous progression).
2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles (i.e., Shaffer Grade 2 or less extreme narrow angle with complete or partial closure). Note , Previous laser peripheral iridotomy is NOT acceptable.
3. Use of more than two ocular hypotensive medications within 28 days of screening. Note fixed dose combination medications, for the purpose of this exclusion criterion, count as one medication
4. Known hypersensitivity to any component of the investigational formulations or to Latanoprost
5. Patients with COVID-19 signs and symptoms
6. Previous glaucoma intraocular surgery, including SLT or ALT in either eye
7. Refractive surgery in either eye (eg, radial keratotomy, PRK, LASIK, corneal cross-linking)
8. Ocular trauma within six months prior to screening, or ocular surgery or non-refractive laser treatment within three months prior to screening.
9. Recent or current evidence of ocular infection or inflammation in either eye. Current evidence of clinically significant blepharitis, conjunctivitis, keratitis, or a history of herpes simplex or zoster keratitis in either eye at screening
10. Use of ocular medication in either eye of any kind within 30 days of screening and throughout the study, with the exception of a) ocular hypotensive medications (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after, screening), c) lubricating drops for dry eye (which may be used throughout the study), or d) non-steroid allergy drops (note. must not contain a vasoconstrictor) as prescribed by the Investigator.
11. Subjects with known mean central corneal thickness greater than 580 μm
12. Any abnormality preventing reliable applanation tonometry of either eye (eg, keratoconus)
13. Subjects with known case of any severe or advanced cases of Glaucoma as per investigator discretion
14. Subjects who are blind or subjects who have a single eye
15. History of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
16. Subjects using contact lenses.
17. Subjects having local administration of corticosteroids injections in the eye
18. Participation in any investigational study within 30 days prior to screening
19. Systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study, including any corticosteroid-containing drug regardless of route of administration
20. Subjects with history of CVS, Hepatic, Psychiatric, Cancer or renal diseases which could be considered significant for the subject to be enrolled in the study
21. Subjects with Type 1 and uncontrolled Type 2 Diabetes Mellitus (i.e., HbA1c Level greater than 7 percentage).
22. Patients with any clinically significant lab abnormalities by condition which in the opinion of investigator would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements
23. Pregnant or lactating women
24. Patient with known alcohol or other substance abuse within last one year as per DSM -5 criteria.
25. Employee of the sponsor, investigator, or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees of sponsor or the investigator.
Note. In case both the eyes of a single subject are affected then the eye fulfilling the criteria will be considered for the evaluations. If both eyes are fulfilling the criteria, then the right eye will be considered for the study.



 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate efficacy of Fixed Dose Combination of Netarsudil 0.02% plus Latanoprost0.005% w/v Ophthalmic Solution in comparison to monotherapy of Netarsudil 0.02% w/v Ophthalmic Solution and Latanoprost 0.005% w/v Ophthalmic Solution for the treatment of elevated intraocular pressure with open angle glaucoma or ocular hypertension patients.   Visit 1: Screening Visit (Day -28 to Day 0), Visit 2: Baseline Visit (week0/Day 1),Visit 3: (Week 4/Day 28 ± 2 days),Visit 4: (Week 8/Day 56 ± 2 days),Visit 5: End of Study/Early Discontinuation Visit (12 weeks/Day 84 ± 4 days). 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate safety of Fixed Dose Combination of Netarsudil 0.02% plus Latanoprost 0.005 percentage w/v Ophthalmic Solution in comparison to monotherapy of Netarsudil 0.02% w/v Ophthalmic Solution and Latanoprost 0.005 percentage w/v Ophthalmic Solution for the treatment of elevated intraocular pressure with open angle glaucoma or ocular hypertension patients.  Patients shall complete five scheduled clinic visits as follows:
• Visit 1: Screening Visit (Days -28 to Day 0)
• Visit 2: Randomization/Baseline Visit (week 0/Day 1)
• Visit 3: Interim Visit (Week 4/Day 28 ± 2 days)
• Visit 4: Interim Visit (Week 8/Day 56 ± 2 days)
• Visit 5: End of Study/Early Discontinuation Visit (12 weeks/Day 84 ± 4 days)
 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
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)   20/07/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

This is a Multi-Center, Double-Blind, Randomized, Active-Controlled, Comparative, Parallel-Group, Phase III Clinical Study to Evaluate the intraocular pressure (IOP)-lowering efficacy and safety of FDC of Netarsudil and Latanoprost Ophthalmic Solution with monotherapy of Netarsudil Ophthalmic Solution and Latanoprost Ophthalmic Solution in patients with open-angle glaucoma or ocular hypertension. 

Male and non-pregnant, non-lactating female subjects, 18 to 65 years of age (both inclusive), for the treatment of elevated intraocular pressure with open angle glaucoma or ocular hypertension patients.

 Study Period: Total study duration for the clinical part shall be of 12 weeks

This Phase III study consists of following visits. 

• Visit 1: Screening Visit (Day -28 to Day 0) 

• Visit 2: Randomization/Baseline Visit (week0/Day 1) 

• Visit 3: Interim Visit (Week 4/Day 28 ± 2 days)

• Visit 4: Interim Visit (Week 8/Day 56 ± 2 days) 

• Visit 5: End of Study/Early Discontinuation Visit (12 weeks/Day 84 ± 4 days)

 After informed consent process, completion of all screening assessments and once all the inclusion/exclusion criteria are met, the eligible subjects shall be enrolled into the study. At randomization/baseline visit, subjects shall be randomly assigned (Double-blind) in 1:1:1 fashion to one of the three treatments. Approximately 216 patients shall be enrolled/randomized.

 Study Period: Total study duration for the clinical part shall be of 12 weeks

 Safety Parameter: Safety will be assessed by the monitoring of adverse clinical events and physical examinations. All AEs & SAEs   occurring during the study will be recorded and reported. 


 
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