| 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
|
|
|
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
|
|
|
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. |