| CTRI Number |
CTRI/2019/04/018738 [Registered on: 24/04/2019] Trial Registered Prospectively |
| Last Modified On: |
13/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Research study to evaluate safety and effectiveness of preservative free bimatoprost 0.01% ophthalmic solution in comparison to conventional bimatoprost 0.01%) ophthalmic solution in glaucoma or ocular hypertension patients in Indian population |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of bimatoprost 0.01% (Careprost) preservative-free (PF) ophthalmic solution in comparison toconventional bimatoprost 0.01% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension in Indian population |
| Trial Acronym |
ET1901001 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ET1901001 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhaumik Mody |
| Designation |
Overall Trial Coordinator |
| Affiliation |
EthiTrials Contract Research Pvt Ltd |
| Address |
Ethitrials Contract Research Pvt. Ltd., India, 916, Devpath Complex, B/h Lal Bunglow, Off C.G. Road, Navrangpura, Ahmedabad - 380009
Ahmadabad GUJARAT 382210 India
Ahmadabad
GUJARAT
380009
India |
| Phone |
917966174411 |
| Fax |
|
| Email |
bhaumik.mody@ethitrials.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical monitor |
| Affiliation |
EthiTrials Contract Research Pvt Ltd |
| Address |
Ethitrials Contract Research Pvt. Ltd., India,
916, Devpath Complex,
B/h Lal Bunglow, Off C.G. Road,
Navrangpura, Ahmedabad - 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
917966174411 |
| Fax |
|
| Email |
nayan.patel@ethitrials.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical monitor |
| Affiliation |
EthiTrials Contract Research Pvt Ltd |
| Address |
Ethitrials Contract Research Pvt. Ltd., India,
916, Devpath Complex,
B/h Lal Bunglow, Off C.G. Road,
Navrangpura, Ahmedabad - 380009
Ahmadabad
GUJARAT
380009
India |
| Phone |
917966174411 |
| Fax |
|
| Email |
nayan.patel@ethitrials.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Laboratories Ltd.
Sun House
Plot No. 201, B/1, Western Express Highway, Goregaon (E), Mumbai 400063 |
|
|
Primary Sponsor
|
| Name |
Sun Pharma Laboratories Ltd |
| Address |
Sun House, 201 B/1, Western Express Highway, Goregaon(E), Mumbai 400063, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kantha Sree |
Gandhi hospital Museerabad |
Room Number 333, 2nd floor,
Department of Ophthalmology, Gandhi Hopsital, Museerabad, Secuderabad-500003
Hyderabad
TELANGANA |
9000986199
kanthasreebugge@gmail.com |
| Dr Vivekananda Reddy M |
LV Prasad Eye Institute Vijayawada |
Room no. 221, 1st Floor, Department of Ophthalmology,beside Library KVC (Kode Ventakadri Chowdary) Campus, Tadigadapa, Vijayawada-521134
Krishna
ANDHRA PRADESH |
9052992024
docmrv@gmail.com |
| Dr Purvi Raj Bhagat |
M & J Western regional institute of ophthalmology |
110/113, Glaucoma Unit , B J Medical College and Civil Hospital, Asarwa
Ahmadabad
GUJARAT |
919825985265
dr.purvibhagat@yahoo.com |
| Dr A Parivadhini |
Sankara Nethralay |
Room number 204, 2nd floor, Department of Glaucoma,Sankara Nethralaya, 18/14, College Road, Nugambakkam, Chennai-600006
Chennai
TAMIL NADU |
9840126173
drap@snmail.org |
| Dr Reema Raval |
Shri C H Nagri municipal eye hospital |
118 Glaucoma Department ,
Smt. NHL Municipal Medical College,
Ellise bridge,
Ellisbridge
Ahmadabad
GUJARAT |
917926466724
ravalreema@yahoo.com |
| Dr Sheshadri mahajan |
St. Theresas hospital |
Room number 1, Department of Ophthalmologist, St. Theresa Hospital, Sanathnagar, Hyderabad-500018
Hyderabad
TELANGANA |
8686494949
drsheshadri@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE ST. THERESAs HOSPITAL |
Approved |
| Institutional Ethics Committee, B J Medical College and Civil Hospital, Ahmedabad |
Approved |
| Institutional Ethics Committee, Gandhi Medical College,Secunderabad. |
Approved |
| Institutional Ethics Committee, SMT. NHL Municipal Medical college, Ahmedabad |
Approved |
| LV Prasad Eye Institute Ethics Committee |
Approved |
| The Institutional Ethics Committee, Vision Research Foundation, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H400||Glaucoma suspect, (2) ICD-10 Condition: H401||Open-angle glaucoma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bimatoprost Ophthalmic Solution 0.01% w/v (benzalkonium chloride free) |
Once a day for 12 weeks |
| Comparator Agent |
Conventional Bimatoprost 0.01% ophthalmic solution |
Once a day for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Men and women aged ≥18 years.
2) Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG) in one eye or both eyes
3) Unmedicated IOP ≥ 22 -30 mmHg in one or both eyes with no more than 5 mmHg inter-eye difference
4) Willing to give informed consent.
5) Best corrected visual acuity equivalent to a Snellen score of 20/100 or better in each eye.
6) For ongoing medication below is acceptable minimum washout period.
04 days for parasympathomimetic and topical or systemic carbonic anhydrase inhibitors,
02 weeks for sympathomimetics and α-agonists
04 weeks for β-adrenergic blocking agents, combination products and prostaglandin agonists
7) Women of child bearing potential practicing an acceptable method of birth control as judged by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), oral or long acting injected contraceptives] from at least 2 months prior to study entry and through the duration of the study; or be postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); or with a negative urine pregnancy test. |
|
| ExclusionCriteria |
| Details |
1) History of allergic hypersensitivity or poor tolerance to any of the components of the preparations to be used in this study.
2) Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator).
3) Intraocular conventional surgery or laser surgery within six months of the study.
4) Use of contact lenses during the study;
5) Use of systemic corticosteroids within 21 days before any study visit;
6) Use of ophthalmic corticosteroids within 2 months or during the study;
7) History of inadequate IOP control on bimatoprost monotherapy;
8) Any clinical ocular surface ï¬ndings at baseline such as trace or greater hyperaemia or irritation.
9) Refractive surgery in the study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months.
10) Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy.
11) Ocular trauma within the past 3 months.
12) Progressive retinal or optic nerve disease apart from glaucoma or a torn posterior lens or having had a risk for macular edema.
13) Concurrent infectious/non-infectious conjunctivitis, keratitis, or uveitis in either eye.
14) Other than ocular hypotensive drugs, which must be washed out according to the provided schedule, ocular medication of any kind (with the exception of lubricating drops for dry eye) within 30 days of baseline.
15) Any abnormality preventing stable applanation tonometry.
16) Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca), which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive drugs, is not judged safe.
17) Clinically significant systemic disease, which might interfere with the study.
18) History of non-compliance to medical regimens or unwilling to comply with the study protocol.
19) Patients having uncontrolled hypertension.
20) Participation in another clinical study within thirty (30) days.
21) Changes in systemic medication within 30 days prior to screening that could have a substantial impact on IOP, or anticipated changes during the study.
22) Patients who are pregnant, nursing a child or who are not willing to use acceptable methods of contraception during the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in intraocular pressure (IOP) of the subject’s eye/eyes. |
Baseline to week 12. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in intraocular pressure (IOP) of the subject’s eye/eyes |
from baseline to Week 2 and Week 6. |
| Changes in Visual acuity of eye/eyes |
Baseline to week 2, week 6 and week 12 |
| Changes in Conjunctival hyperemia of eye/eyes |
Baseline to week 2, week 6 and week 12 |
| Safety monitoring by AE assessment |
Throughout the study period |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 4 |
|
Date of First Enrollment (India)
|
01/05/2019 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed to evaluate the safety and efficacy of a preservative- free(PF) bimatoprost 0.01% formulation that was developed as an alternative for patients with sensitivity or allergies to preservatives. This is an open label, prospective, randomized, multi-center, controlled, parallel group, non-inferiority clinical phase IV study in 200 Indian patients. The study will include at least 4 evaluation points: Enrollment Visit and patient assessments at 02 weeks, 06 weeks and 12 weeks after randomization. Eligible patients will be enrolled as per Inclusion and exclusion criteria. Subjects will be randomized as per 1:1 study treatment ratio. Statistics team will prepare a randomization and it will be provided to each investigator for enrollment. Patients will be provided/dispensed study medication kits containing unit-dose containers (each for single use) both formulations. Patients will be instructed to instill one drop in each affected eye once daily in the evening, starting on the day of the baseline visit. Follow-up visits are scheduled at weeks 2, 6 and 12. IOP will be measured using a tonometer at 8:00, 12:00 and 16:00 (within 01 hour of scheduled time) at each visit. Efficacy Variable will be measure as change in Intraocular Pressure (IOP) from baseline of the study eye at each time points. Safety analysis include Visual Acuity, Conjuctival Hyperemia, any AEs |