| CTRI Number |
CTRI/2020/01/022619 [Registered on: 06/01/2020] Trial Registered Prospectively |
| Last Modified On: |
22/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of Netarsudil Ophthalmic Solution 0.02% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in treatment of elevated intraocular pressure in patient with open angle glaucoma or ocular hypertension. |
|
Scientific Title of Study
|
A Comparative, Randomized, Two Arm, Double Blind, Parallel Group, Multicentric, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Netarsudil Ophthalmic Solution 0.02% w/v Versus Timolol Maleate Eye Drops 0.5% w/v in treatment of elevated intraocular pressure (IOP) in subjects with open angle glaucoma or ocular hypertension. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APL/CT/18/03 |
Protocol Number |
| Protocol version - 0, Dated: Mar 01, 2018 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Kantha Sree |
| Designation |
Principal Investigator |
| Affiliation |
Gandhi Hospital, Musheerabad, Secunderabad |
| Address |
Musheerabad Secunderabad Telangana
Hyderabad
TELANGANA
500003
India |
| Phone |
9618888684 |
| Fax |
|
| Email |
kanthasreebagge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Sr Vice President R&D and Regulatory Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43AB/44BCD, Charkop Industrial Estate,
Kandivli West.
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
02228672111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh Singh |
| Designation |
Sr Vice President R&D and Regulatory Affairs |
| Affiliation |
Ajanta Pharma Ltd |
| Address |
Ajanta Pharma Ltd, Advent 43AB/44BCD, Charkop Industrial Estate,
Kandivli West.
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
02228672111 |
| Fax |
|
| Email |
shailesh.singh@ajantapharma.com |
|
|
Source of Monetary or Material Support
|
| Ajanta Pharma Ltd, Advent 43 AB/ 44 BCD Charkop Industrial Estate Kandivali West, Mumbai Maharashtra |
|
|
Primary Sponsor
|
| Name |
Ajanta Pharma Ltd |
| Address |
Advent 43 AB / 44BCD, Charkop Industrial Estate, Kandivali West.
Mumbai. Maharashtra 400067 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR VIPPUTURI VENKATA LAKSHMI NARASMIHA RAO |
Dr. R.S.P.R. Govt. Regional Eye Hospital |
Dr. R.S.P.R. Govt. Regional Eye Hospital, Opposite Bullyya college Resapuvani Palem, Visakhapattanam 530013 Andhrapradesh India.
Visakhapatnam
ANDHRA PRADESH |
9885268979
8912555668
vvlclinicalresearch@gmail.com |
| DrArchana Swarnakar |
Getwell Hospital and Research Institute |
Dr.Archana Swarnakar
20/1, Getwelll:!ospital and Research Institute
Dr.Khare Marg, Dhantoli, Nagpur-4400 12
Nagpur
MAHARASHTRA |
07412663220
07122441046
giec201@gmail.com |
| DrShalini Mohan |
GSVM medical college |
GSVM medical college, Swaroop Nagar Kanpur
Kanpur Nagar
UTTAR PRADESH |
09506740966
drhalinimohan@gmail.com |
| DrPradeep Kumar Saraf |
Health Point Hospital, 21, Prannath Pandit Street, Opp Lansdown, Paddapukur, |
Dr Pradeep Kumar Saraf,
Health Point Hospital, 21, Prannath Pandit Street, Opp Lansdown, Paddapukur, Kolkata, West Bengal 700025
Kolkata
WEST BENGAL |
9830060806
03324747985
pksaraf@myeyeworld.com |
| Dr Rakesh Porwal |
Jawaharlal Nehru Medical College |
Kala bagh, Ajmer-305001, Rajasthan, India
Ajmer
RAJASTHAN |
9414004414
ethicscare@ecrsindia.com |
| Dr Vikas Gupta |
Maharaja Agrasen hospital |
Jaipur, Sector7, Vidhyadhar Nagar Marg, Central Spine, Jaipur-302023, Rajasthan, India.
Jaipur
RAJASTHAN |
08769093931
drvikaseye@gmail.com |
| Dr Tarkeshwar Rao |
Rajiv Gandhi Institute of Medical Science & RIMS Govt |
Prof. & HOD, of Dept. Of Ophthalmology Rajiv Gandhi Institute of Medical Science & RIMS Govt. General Hospital.
Srikakulam
ANDHRA PRADESH |
09441873644
08942279033
tarakeye@gmail.com |
| Dr Lakshmi Mondal |
Regional Institute of Ophthalmology Medical College and Hospital |
88 College Street Kolkata-700073, West Bengal, India
Kolkata
WEST BENGAL |
9830830216
lakshmi.mondal62@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee GSVM Medical College |
Approved |
| Getwell Hospital and Research Institute |
Approved |
| Health Point Hospital, A MULTI· SPECIALITY HOSPITAL |
Approved |
| IEC, Maharaja Agrasen Superspecialty Hospital |
Approved |
| Institutional Ethics Committee Rajiv Gandhi Institute of Medical Sciences & RIMS Government General Hospital |
Approved |
| Institutional Ethics Committee JLN Medical College |
Approved |
| Institutional Ethics Committee KGH |
Approved |
| Institutional Ethics Committee Regional Institute of Ophthalmology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Netarsudil Ophthalmic Solution 0.02% w/v |
Instill one drop in the affected eye twice daily for 90
days |
| Comparator Agent |
Timolol Maleate Eye Drops 0.5% w/v |
Instill one drop into the affected eye twice daily for 90
days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects meeting all of the following criteria will be recruited for the trial
1.Male and Female subjects between 18 – 65 years of age (both inclusive).
2.Newly diagnosed patients of primary open angle glaucoma / ocular hypertension in at least one eye confirmed by Goldmann applanation tonometry.
3.Subjects with IOP between 22 mmHg – 27 mmHg at the time of screening in any one eye. 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.
4.Visual acuity 6/60 or better.
5.Voluntary willingness of patient to give written informed consent prior to participation in trial. |
|
| ExclusionCriteria |
| Details |
Subjects will be excluded if ANY of the following conditions apply:
Ophthalmic:
1.Subjects with any severe or advanced cases of Glaucoma
2.Shaffer angle grade ≤ 2 in either eye, as measured by Gonioscopy
3.Subjects with pseudoexfoliation or pigment dispersion component glaucoma
4.Subjects who are blind or subjects who have a single eye.
5.Severe central visual field loss in either eye measured by Perimetry
6.Cup/disc ratio greater than 0.80
7.Current or history within three months prior to baseline of significant ocular disease, e.g., corneal edema, uveitis, ocular infection, or ocular trauma in either eye.
8.Current corneal abnormalities that would prevent accurate IOP readings with the Goldmann applanation tonometer.
9.Subject who have history of any ocular surgery in either eye in past (e.g. peripheral iridotomy, glaucoma incisional or laser surgery, refractive surgery) or are planning to undergo any ocular surgery during study period
10.Subjects having central corneal thickness greater than 600 mm in either eye
11.History of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
12.Subjects using contact lenses.
13.Contraindication or hypersensitivity to any component of study medication
14.Subject having history of chronic use of any ocular medication
15.Subjects having local administration of corticosteroids injections in the eye
Others:
16.Use within one month prior to baseline of: 1) systemic corticosteroid or 2) high-dose salicylate therapy or 3) Oral carbonic anhydrase inhibitor
17.Females who are pregnant, breast feeding, or planning a pregnancy.
18.Females of childbearing potential who do not agree to utilize an adequate form of contraception
19.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.
20.Subjects with/history of Bronchial Asthma, bronchial hyper reactivity or severe COPD that would preclude the safe administration of a topical beta blocker.
21.Subjects on these listed medications will be excluded from the study: a) High-dose (>1 gm daily) salicylate b) Topical as well as Oral β-Blockers c) alpha agonists and blockers d) ACE inhibitors and calcium channel blockers e) Systemic administration of corticosteroids or immunosuppressive agents.
22.Participation in any clinical study within 30 days prior to entry into the study.
23.Subject not willing to comply with the study protocol and does not provide written informed consent to participation
24.Subjects with Type 1 and uncontrolled Type 2 Diabetes Mellitus (i.e. defined as Glycosylated HbA1C Level >7%). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Reduction in IOP at the end of 12 weeks of treatment as compared to baseline at 9.00 AM, 11.00 AM and 5.00 PM |
Day 0 and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean Reduction in IOP at the end of 4 weeks of treatment as compared to baseline
Mean Reduction in IOP at the end of 8 weeks of treatment as compared to baseline.
The assessment of safety of Subjects (comparison of incidence of treatment emergent adverse event (TEAE)) and change in ophthalmogical parameters.
The assessment of tolerability of Investigational Product will be based on incidence of AEs and SAEs and Changes in laboratory values. |
Day 0, Day 28 and Day 56 |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= "197"
Final Enrollment numbers achieved (India)="197" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/01/2020 |
| Date of Study Completion (India) |
28/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Comparative, Randomized, Two Arm, Double Blind, Parallel Group, Multicentric, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Netarsudil Ophthalmic Solution 0.02% w/v Versus Timolol Maleate Eye Drops 0.5% w/v in treatment of elevated intraocular pressure (IOP) in subjects with open angle glaucoma or ocular hypertension. recrutment started on January 06,2020 and study has completed on 28 Aug 2020. |