| CTRI Number |
CTRI/2010/091/000095 [Registered on: 29/01/2010] |
| Last Modified On: |
08/01/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
This is a postmarketing surveillance to determine the efficacy and safety of 0.05 % Cyclosporine ophthalmic micro-emulsion for the treatment of Moderate to Severe Dry eye disease |
Scientific Title of Study
Modification(s)
|
An open label, multicentre postmarketing surveillance to evaluate the efficacy and safety of 0.05 % Cyclosporine ophthalmic micro-emulsion for the treatment of Moderate to Severe Dry eye disease |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CP/18/09 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Nikhil Gokhale |
| Designation |
Ophthalmologist |
| Affiliation |
Gokhale Eye Hospital |
| Address |
Gokhale Eye Hospital,
1st Floor, Anant Building, Near Portuguese Church, Above UCO Bank, Gokhale Road South, Dadar West, Mumbai
Mumbai
MAHARASHTRA
400028
India |
| Phone |
9820154362 |
| Fax |
022-24315666 |
| Email |
nikgokhale@yahoo.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Jaideep A Gogtay |
| Designation |
Medical Director |
| Affiliation |
Cipla Ltd. |
| Address |
Cipla Ltd. Bellasis Road, Mumbai Central, Mumbai 400 008
Mumbai
MAHARASHTRA
400 008
India |
| Phone |
022-23025412 |
| Fax |
02225787855 |
| Email |
jgogtay@cipla.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Nikhil Gokhale |
| Designation |
Ophthalmologist |
| Affiliation |
Gokhale Eye Hospital |
| Address |
Gokhale Eye Hospital,
1st Floor, Anant Building, Near Portuguese Church, Above UCO Bank, Gokhale Road South, Dadar West, Mumbai
Mumbai
MAHARASHTRA
400028
India |
| Phone |
9820154362 |
| Fax |
022-24315666 |
| Email |
nikgokhale@yahoo.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Cipla Ltd., Bellasis Road, Mumbai Central, Mumbai 400 008. Phone:(022) 23082891 Fax:(022)23070013 |
|
Primary Sponsor
Modification(s)
|
| Name |
Cipla Ltd |
| Address |
Bellasis Road, Mumbai Central, Mumbai 400 008. Phone:(022) 23082891 Fax:(022)23070013 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Bharti C. Lavingia |
Cornea Foundation |
Suyog Building, 2nd Floor, Near Kamla Kamdhenu Hall, Drive In road, Ahmedabad 380052 ,NIL-380052
Ahmadabad
GUJARAT |
(079) 27497815
NIL
dr_bclavingia@hotmail.com |
| Dr Dipan Desai |
Diva Eye Institute |
17, Parimal Society, Core House Lane, Opposite Apollo City Centre, Parimal Gardens, Ahmedabad 380006,NIL-380006
Ahmadabad
GUJARAT |
079-26569596
079-26408728
dipan.desai@divaeyeinstitute.com |
| Dr. Nikhil Gokhale |
Gokhale Eye Hospital |
Anant Building, Gokhale road (South), Dadar (West), Mumbai 400 028,NIL-400028
Mumbai
MAHARASHTRA |
(0) 9820154362
(022) 24315666
nikgokhale@yahoo.com |
| Dr. Upsham Goel |
T C Eye Centre |
B - 5/37, Vinay Khand, Gomti Nagar, Lucknow 226010,NIL-226010
Lucknow
UTTAR PRADESH |
09335231334
NIL
upsham@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Clinicom Independent Ethics Committee, Bangalore; for Cornea Foundation |
Approved |
| Clinicom Independent Ethics Committee, Bangalore; for Diva Eye Institute |
Approved |
| Clinicom Independent Ethics Committee, Bangalore; for Gokhale Eye Hospital |
Approved |
| Clinicom Independent Ethics Committee, Bangalore; for T C Eye Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Moderate to severe Dry Eye Disease, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Cyclosporine |
Cyclosporine ophthalmic microemulsion 0.05% one drop in both eyes to be administered twice daily |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects willing to give written informed consent.
2.Subjects of either sex of 18 years and above.
3.Ocular Surface Disease Index Score greater than or equal to 0.25, unless subject has Sjogren syndrome or thyroid autoimmune disease.
4.Schirmer?s test with anesthesia of less than 5 mm / 5 min.
5.Best corrected visual acuity greater than 6/24.
6.In the opinion of the investigator, able to comply with the requirements of the protocol.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with hypersensitivity to study drug or any exipients of its formulation.
2.Presence or history of any systemic or ocular disorder or condition including ocular surgery, trauma, or ocular disease that could interfere with interpretation of study results.
3.Current or recent use of topical ophthalmic or systemic medications that could affect dry eye condition.
4.Required contact lenses wear during study.
5.Current infections of the anterior segment or uveitis.
6.Any disease of the eye leading to diffuse loss of conjunctiva including ocular pemphigoid, chemical burns, steven Johnson syndrome and hypervitaminosis A.
7.Any active ocular diseases excluding glaucoma other than blepharitis.
8.Within one month or anticipated use of temporary punctual plugs during study or permanent occlusion of lacrimal puncta within 3 months.
9.Participated in an investigational study 30 days prior to screening visit.
10.Females who are pregnant, lactating or planning to become pregnant.
11.End stage Lacrimal gland disease (scheimer's reading with nasal stimulation of < 3 mm/5min) or if the dry eye disease is as a result of destruction of conjunctival goblet cells or scarring.
12.Judged by Investigator to be inappropriate as subjects. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean change in Schirmers tear test score |
At week 4 from baseline |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean change in Ocular Surface Disease Index Score |
At week 2 and week 4 from baseline |
| Mean change in Ocular discomfort |
At week 2 and week 4 from baseline |
| Global evaluation of overall effect of study medication |
At week 4 from baseline |
| Use of artificial tears |
At week 4 from baseline |
| Incidence and nature of adverse events |
During the study period |
| Incidence of drug related adverse events |
During the study period |
| Clinically significant changes in the ocular examination |
During the study period |
|
Target Sample Size
Modification(s)
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
15/01/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a Phase- IV open label post marketing surveillance to determine the efficacy and safety of 0.05 % Cyclosporine ophthalmic micro-emulsion for the treatment of Moderate to Severe Dry eye disease. This study was conducted at four centres through out the India. This study consists of 4 weeks of treatment period. In this study Mean change in Schirmer's test score at week four from the baseline visit was determined as a primary endpoint. Mean change in Ocular Surface Disease Index Score, mean change in Ocular Discomfort, global evaluation of overall effect of study medication and use of artificial tears were determined as secondary endpoints. Incidence and nature of drug related adverse events, clinically significant changes in the ocular examination were assessed as a safety endpoints. |