CTRI/2024/11/076185 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On:
06/02/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
Effects of Cyclosporine Eye Drops to Increase Tear Production in Patients with Dry Eye Disease
Scientific Title of Study
A Prospective, Multi-centre, Single-arm, Phase IV Study to Assess the Safety and Efficacy of Cyclosporine 0.09% w/v Ophthalmic Solution to Increase Tear Production in Patients with Keratoconjunctivitis Sicca (Dry Eye)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/21/021, Version No. 2.0, Dated 15/MAR/2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
Associate Vice President & Head - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai-400063, Maharashtra, India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
9819767704
Fax
02243244323
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Shruti Saha
Designation
Manager – India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201 B/1,
Western Express Highway, Goregaon (E),
Mumbai - 400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244323
Email
shruti.saha@sunpharma.com
Details of Contact Person Public Query
Name
Dr Rajiv Yadav
Designation
Senior Manager-India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E),
Mumbai - 400063, Maharashtra, India.
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
02243244343
Email
Rajiv.Yadav1@sunpharma.com
Source of Monetary or Material Support
Sun Pharmaceutical Industries Limited (SPIL)
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Primary Sponsor
Name
Sun Pharma Laboratories Limited SPLL
Address
Sun House, Plot No. 201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400 063, Maharashtra, India.
Department of opthalmology, Sijua, Patrapada, Bhubaneshwar-751019, Odisha. Khordha ORISSA
9437044380
suchetaparija@yahoo.com
Dr Rohit Sanjay Laul
Chopda Medicare & Research Centre Pvt. Ltd
Ground Floor, Opthalmology Dept, Magnum Heart Institute, 3/5, Patil Lane No.1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner, Nashik-422005, Maharashtra, India Nashik MAHARASHTRA
9656442160
drlaulrs@gmail.com
Dr Samar Basak
Disha Eye Hospitals Pvt. Ltd
88(63A) Ghosh Para Road, Barrackpore, Kolkata-700156, West Bengal. Kolkata WEST BENGAL
9830323013
basak_sk@hotmail.com
Dr Dahiya Sumita
Dr D Y Patil Medical College Hospital& Research Center
OPD 51, Department of Ophthalmology Plot No 2 Sector 5, Nerul, and Navi Mumbai-400706. Thane MAHARASHTRA
Ethics Committee S.M.S. Medical College and Attached Hospitals
Approved
IEC King George hospital
Submittted/Under Review
Institute Ethics Committee_Sankara Eye Hospital
Approved
Institutional Ethics Committee, AIIMS Bhubaneswar
Approved
Institutional Ethics Committee, Dr D Y Patil Medical College, Hospital and Research Center
Submittted/Under Review
Institutional Ethics Committee, M&J Institute of Ophthalmology
Approved
Institutional Ethics Committee_Regional Institute of Ophthalmology
Submittted/Under Review
KIMS Ethics Committe
Approved
L V Prasad Eye Institute Ethics Committee
Submittted/Under Review
Lifepoint Research Ethics Committee
Submittted/Under Review
Magna- Care Ethics Committee
Submittted/Under Review
Narayana Nethralaya Ethics Committee
Submittted/Under Review
Opal Institutional Ethics Committee
Submittted/Under Review
Regional Institute of Ophthalmology, Institutional Ethics Committee
Approved
Sangini Hospital Ethics Committee_Netralaya Super Speciality Hospital
Approved
Santosh Hospital Institutional Ethics Committee
Approved
Shantilal Shanghvi Foundation 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: H041||Other disorders of lacrimal gland,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
NIL
NIL
Intervention
Test: Cyclosporine 0.09% w/v Ophthalmic Solution
One drop of the test drug should be instilled into each eye twice daily approximately 12 hours apart for 12 weeks.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1) Male, and non-pregnant, non-lactating female patients of age ≥ 18 years who agree to provide written informed consent.
2) Patients with history of keratoconjunctivitis sicca (KCS) for a period of at least 6 months
3) Patients with clinical diagnosis of bilateral KCS.
4) Patients with Lissamine green conjunctival staining score of ≥ 3 to ≤ 9.
5) Patients with reported dry eye symptoms within 3 months prior to study.
6) Patients with corrected Snellen visual acuity (VA) of better than 20/200 in each eye
7) Willing to discontinue use of current therapy for KCS.
8) Women of childbearing potential must have a negative urine pregnancy test before study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication.
9) Male patients must have had a successful vasectomy or they and their female partners must meet the criteria above. No sperm donation is allowed during the study period.
ExclusionCriteria
Details
1)Patients using cyclosporine ophthalmic preparations within 3 months prior to the Screening Visit.
2)Patients with history of previous treatment failure with cyclosporine ophthalmic solutions.
3)Patients with diagnosis of Sjogrens disease more than 5 years prior to the Screening visit.
4)Patients with clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
5)Patients using the following systemic or topical medications within 7 days prior to the Screening Visit or intended to use during the study period such as Immunomodulators, Systemic corticosteroids, Antihistamines, Cholinergics, Antimuscarinics, Tricyclic antidepressants, Phenothiazines, and Retinoids.
6)Patients using any topical ophthalmic medications, prescription or over the counter, other than the assigned study medication during the study period.
7)Patients on oral omega-3 fatty acids.
8)Patients with unstable macular disease.
9)Diagnosis of chronic uveitis or any chronic or potentially recurrent ocular condition.
10)Patients with current active eye disease other than KCS (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
11)Patients with any ocular disorder including ocular injury, infection, non-dry eye ocular inflammation, trauma, or surgery within the prior 6 months.
12)Patients with history of herpes keratitis.
13)Patients with history of corneal transplant.
14)Patients with history of corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved.
15)Patients who require surgical correction of dry eyes, and Contact lens wearers.
16)Patients with history of cataract surgery within 3 months prior to the Screening Visit.
17)Patients who have undergone non-laser glaucoma surgery at any time; or glaucoma laser procedures within 3 months prior to the Screening Visit.
18)Patients with lagophthalmos or clinically significant eyelid margin irregularity of either eye whether congenital or acquired.
19)Patients with history of any cancer within 5 years of screening.
20)Patients who have plans to undergo major elective surgery during the course of the study.
21)Patients with history of or currently having any of the severe/serious ocular condition or clinically significant medical conditions, such as cardiovascular, respiratory, renal, hepatic, endocrine, or gastrointestinal disease.
22)Patients with history of or known case of HIV-AIDS, hepatitis B, and hepatitis C.
23)Patients with history of hypersensitivity or allergic reaction study medication or its component(s).
24)Participation in other studies involving investigational drugs or surgeries within the last 30 days or investigational biologics within the last 6 months.
25)Investigator, study personnel, Sponsor representatives and their first degree relatives.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Safety:
Proportion of patients with treatment-emergent adverse events (TEAEs)
Day 1, Day 28, Day 56 & Day 84
Secondary Outcome
Outcome
TimePoints
Efficacy:
Proportion of patients with increase from baseline of ≥10 mm in Schirmers Test (Unanesthetized) Score based on data for both eyes
Day 28, 56 & 84
Efficacy:
Change from baseline in Schirmer’s Test (Unanesthetized) Score based on data for both eyes
Day 28, 56 & 84
Efficacy:
Change from baseline in Conjuctival (Lissamine green) staining score based on data for both eyes
Day 28, 56 & 84
Efficacy:
Change from baseline in Corneal fluorescein staining score based on data for both eyes
Day 28, 56 & 84
Efficacy:
Change from baseline in dry eye symptoms using SPEED Questionnaire score
Days 28, 56 & 84
Target Sample Size
Total Sample Size="142" Sample Size from India="142" 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)
15/11/2024
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)
Not Applicable
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
prospective, phase IV, single arm, multicenter, open-label study. The study
will be conducted at approximately 10-15 number of centers in India, having
qualified Investigators. The study will be initiated only after the receipt of
regulatory and ethics committee (EC) approval. After obtaining the
informed consent, patients will be screened by undergoing various assessments
as mentioned in Schedule of Assessment. After confirming the eligibility,
patients will be enrolled by allotting the enrollment number. The enrolled
patients will be given study drug Cyclosporine 0.09% w/v Ophthalmic Solution.
Treatment duration will be of 84 days. During the study, assessments will be
performed as mentioned in Schedule of Assessment.