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CTRI Number  CTRI/2025/08/093426 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 14/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Drug therapy]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Safety and efficacy of Topical Efficacy and safety of Cyclosporine in Moderate to Severe Dry Eye patients in terms of dry eye severity score 
Scientific Title of Study   Safety and efficacy of Topical Cyclosporine on Moderate to Severe Dry Eye: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Phulen Sarma 
Designation  Assistant professor 
Affiliation  AIIMS, Guwahati 
Address  Department of Pharmacology, AIIMS, Guwahati
Silbharal, Changsari, Guwahati – 781101
Kamrup
ASSAM
781101
India 
Phone  8728830834  
Fax    
Email  phulen10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Phulen Sarma 
Designation  Assistant professor 
Affiliation  AIIMS, Guwahati 
Address  Department of Pharmacology, AIIMS, Guwahati
Silbharal, Changsari, Guwahati – 781101
Kamrup
ASSAM
781101
India 
Phone  8728830834  
Fax    
Email  phulen10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Phulen Sarma 
Designation  Assistant professor 
Affiliation  AIIMS, Guwahati 
Address  Department of Pharmacology, AIIMS, Guwahati
Silbharal, Changsari, Guwahati – 781101
Kamrup
ASSAM
781101
India 
Phone  8728830834  
Fax    
Email  phulen10@gmail.com  
 
Source of Monetary or Material Support  
Dr. Phulen Sarma (investigator initiated trial) 
 
Primary Sponsor  
Name  Dr Phulen Sarma  
Address  Dr. Phulen Sarma, Pharmacology, AIIMS Guwahati  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Phulen Sarma  AIIMS Guwahati  Ophthalmology/Room no 2072 Pharmacology?Dr. Phulen Sarma Room
Kamrup
ASSAM 
8728830834

phulen10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Guwahati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H048||Other disorders of lacrimal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  0.05% Cyclosporine A + artificial tears (0.3% CMC)  Participants will receive 0.05% Cyclosporine A. Additionally, patients from both the groups will receive artificial tear (0.3% CMC).  
Comparator Agent  0.1% Cyclosporine A + artificial tears (0.3% CMC)  Participants will receive 0.1% Cyclosporine A. Additionally, patients from both the groups will receive artificial tear (0.3% CMC).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Total corneal fluorescein staining (CFS) score greater than or equal to 10
2. Dryness symptom score greater than or equal to 50
3. Total conjunctival staining score greater than or equal to 2
4. Schirmer I test score (without anaesthesia): between 1 mm and 10 mm at 5 minutes
5. Willing and able to comply with the study protocol and scheduled visits
6. Willing provide written informed consent

 
 
ExclusionCriteria 
Details  1. Active ocular infection or inflammation not related to dry eye
2. Ocular surgery or trauma within the past 3 months
3. Use of topical ocular anti-inflammatory medications (including steroids) within 30 days prior to screening
4. Known allergy or hypersensitivity to cyclosporine or any study medication components
5. Presence of systemic autoimmune diseases affecting the eyes
6. Pregnant or breastfeeding women
7. Clinically significant slit-lamp findings or abnormal lid anatomy at screening
8. Ocular/periocular malignancy
9. History of herpetic keratitis
10. Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
11. Use of topical Cyclosporine A within 2 months prior to screening
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess the safety of 0.05% Cyclosporine A versus 0.1% among patients with moderate to sever dry eye.
2. To evaluate the change in Schirmer’s test values in both the groups.
 
Baseline , 1.5 month, 3 month, 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
• To assess the improvement in ocular symptoms (e.g., burning, dryness, foreign body sensation) after treatment with two different regimen of Cyclosporine A (0.05% vs. 0.1%) plus artificial tear.
• To assess changes in Tear Break-Up Time (TBUT) and corneal/conjunctival staining scores.
 
Baseline, 1.5 month, 3 month, 6 month 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   01/09/2025 
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="2"
Months="0"
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  

Dry eye disease (DED) is a multifactorial condition of the ocular surface and tear film characterized by the loss of tear film homeostasis. It affects 5 percent to 50 percent of the adult population globally, with a prevalence of 29.5 percent to 39.62 percent reported in India . Moderate to severe DED can impair daily activities, social functioning, and quality of life . If left untreated, it may lead to chronic corneal epithelial damage, ulceration, and even vision loss or functional blindness in rare cases. Artificial tears remain the mainstay of conventional DED therapy, offering only temporary symptom relief without addressing the underlying inflammation. Cyclosporine A (CsA), an immunomodulatory agent, reduces ocular surface inflammation and promotes tear production. The FDA has approved 0.05 percent topical CsA for moderate to severe DED. RCTs have demonstrated its efficacy over vehicle in improving Schirmer scores and reducing corneal staining. It is considered safe and effective for patients not responding to artificial tears alone. Recent meta-analyses suggest that 0.1 percent CsA is also safe and more effective than vehicle in reducing corneal and conjunctival staining and OSDI scores.The ESSENCE-2 trial confirmed the safety and efficacy of 0.1 percent CsA compared to vehicle but did not evaluate it against artificial tears, limiting its generalizability to real-world clinical practice. A direct comparison between 0.05 percent and 0.1 percent CsA as add-on therapy to artificial tears is needed to establish the superior dose for improving symptoms and clinical outcomes in moderate to severe DED. Our study aims to compare the efficacy and safety of topical 0.05 percent versus 0.1 percent cyclosporine A, both as adjuncts to artificial tears, in patients with moderate to severe dry eye disease.

 
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