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CTRI Number  CTRI/2024/11/076778 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of two commonly used artificial tear substitutes: 0.5% Carboxymethylcellulose and 0.3% hydroxypropyl methylcellulose (HPMC)in patient with mild to moderate dry eye disease. 
Scientific Title of Study   A randomized controlled trial comparing efficacy and safety of two tear substitutes 0.5 percent Carboxymethylcellulose (CMC) versus 0.3 percent hydroxypropyl methylcellulose (HPMC)in patient with mild to moderate dry eye disease. 
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  Pharmacology, AIIMS Guwahati 
Address  Pharmacology, AIIMS Guwahati
Guwahati
Kamrup
ASSAM
781101
India 
Phone  8728830834  
Fax    
Email  phulen10@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sangam Mahobiya 
Designation  M. Pharm 
Affiliation  NIPER Gwahati 
Address  Department of Pharmacy Practice, NIPER Guwahati, changsari, dist. kamrup, Assam
Department of Pharmacy Practice, NIPER Guwahati, changsari, dist. kamrup, Assam
Kamrup
ASSAM
781101
India 
Phone  7389783072  
Fax    
Email  sangamniper@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Phulen Sarma 
Designation  Assistant Professor  
Affiliation  Department of Pharmacology, AIIMS Guwahati 
Address  Department of Pharmacology, 2nd Floor, Medical College Building, AIIMS Guwahati, Changsari, Kamrup, Assam
Department of Pharmacology, 2nd Floor, Medical College Building, AIIMS Guwahati, Changsari, Kamrup, Assam
Kamrup
ASSAM
781101
India 
Phone  8728830834  
Fax    
Email  phulen10@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Guwahati. investigator initiated clinical trial. self funded. 
 
Primary Sponsor  
Name  Phulen Sarma 
Address  AIIMS Guwahati, changsari, kamrup, Assam,781101 
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  Department of Ophthalmology, 2nd Floor, OPD Building
Kamrup
ASSAM 		 8728830834

phulen10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC 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  Carboxymethyl cellulose (CMC)  Dose :0.5% frequency : 4 times in a day duration on interval: 15 days 
Comparator Agent  hydroxypropyl methylcellulose (HPMC)   dose : 0.3% frequency: 4 times in a day. interval duration : 15 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Mild to moderate dry eye
disease (At least in one eye) as
per DEWS II Definition.
2. who is willing to take part in the
study and ready to give
informed consent form.
3. Patients with age between 18-
50 yrs
4. OSDI score15-30.
5. Schirmer test ≥5-10 mm at 5
min without anaesthesia 
 
ExclusionCriteria 
Details  1. Patient who cannot give
informed consent.
2. Subject using contact lens.

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3. Eyelid or blinking disorder.
4. Pregnant and lactating women.
5. Patient on local/systemic
immunosuppressants.
6. Cancer and other clinically
important diseases.
7. Having severe ocular surface
disease.
8. Having ocular infection.
9. Ocular surgery and any
concomitant eye disease.
10. History of allergy to any ocular
medications/Any drugs. 
 
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 
To compare the efficacy of 0.5%
carboxymethylcellulose and 0.3%
hydroxypropyl methyl cellulose in
terms of improvement in OSDI. 		 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the efficacy of
0.5% carboxymethylcellulose
and 0.3% hydroxypropyl methyl
cellulose in terms of corneal
staining score, TBUT and
Schirmer test readings.
2. To evaluate the safety of both
the drugs.
3. To evaluate tear film
proteomics following
application of drugs. 		 15 days 
 
Target Sample Size   Total Sample Size="148"
Sample Size from India="148" 
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)   25/11/2024 
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="1"
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 can potentially cause
damage to the ocular surface and cause
symptoms such as pain, visual impairment,
and instability of the tear film.
According to  the Tear Film & Ocular
Surface Society Dry Eye Workshop II
(TFOS DEWS II) dry eye diseases is
defined as “A multifactorial disease of the
ocular surface characterized by a loss of
homeostasis of the tear film, and
accompanied by ocular symptoms, in
which tear film instability and
hyperosmolarity, ocular surface
inflammation and damage, and
neurosensory abnormalities play
etiological roles’’CMC and HPMC both have been used by
various studies with the result showing
their efficacy in dry eye diseases in mild to
moderate dry eye.While reviewing literature evaluating
comparative efficacy of both the drugs in
mild to moderate dry eye diseases, no
controlled trial or RCT have been found in
Indian population. It is important to know
that although various observational studies
show efficacy of these drugs, but to have a
definitive conclusion regarding which drug
is superior/ recommended needs a
comparative trial which will be useful for
clinicians for choosing the best drug in
their clinical practice as well as patient
acceptability. This RCT is designed to find
out all these answers.Patient will be recruited from
ophthalmology OPD, AIIMS,
Guwahati. The diagnosis of the case
will be done by ophthalmologist for
recruiting the study participants.
Severity of dry eye will be graded as
per DEWS II classification. Detailed
history and baseline examination
findings will be recorded in a case
record form after taking informed
written consent from the patients
explaining in their local language.
Patients fulfilling inclusion/exclusion
criteria and providing written informed
consent will be recruited for the study.
After recruiting the case, eligible
patient will be randomized into two
treatment groups that is Group A: CMC
0.5% group (0.5% CMC four times in a
day) and Group B: HPMC 0.3% group
(0.3% HPMC 4 times in a day) .All population fulfilling inclusion
exclusion criteria and willing to
provide written informed consent will
be randomized
 
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