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CTRI Number  CTRI/2025/07/090848 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 11/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dry eye disease and oral Zinc supplement 
Scientific Title of Study   The efficacy of oral Zinc supplement in young adult patients of dry eye disease associated with acne vulgaris- A Randomized controlled study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sujit Das 
Designation  Associate Professor 
Affiliation  AIIMS Deoghar 
Address  Department of ophthalmology, AIIMS, Deoghar, Jharkhand

Deoghar
JHARKHAND
814152
India 
Phone  8527583337  
Fax    
Email  imdrsujitdas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sujit Das 
Designation  Associate Professor 
Affiliation  AIIMS Deoghar 
Address  Department of ophthalmology, AIIMS, Deoghar, Jharkhand

Deoghar
JHARKHAND
814152
India 
Phone  8527583337  
Fax    
Email  imdrsujitdas@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sujit Das 
Designation  Associate Professor 
Affiliation  AIIMS Deoghar 
Address  Department of ophthalmology, AIIMS, Deoghar, Jharkhand

Deoghar
JHARKHAND
814152
India 
Phone  8527583337  
Fax    
Email  imdrsujitdas@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Deoghar, Jharkahnd-814152, India. 
 
Primary Sponsor  
Name  The Investigator 
Address  Dr Sujit Das, Department of Ophthalmology, AIIMS Deoghar, Jharkhand, PIN: 814152, India 
Type of Sponsor  Other [Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
AIIMS Deoghar  Department of ophthalmology, AIIMS Deoghar Jharkhand, 814152 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujit Das  AIIMS, Deoghar  Department of ophthalmology, AIIMS, Deoghar, Jharkhand
Deoghar
JHARKHAND 		 08527583337

imdrsujitdas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India institute of medical scicences, Deoghar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Male or Female without any acute or chronic illness, especially cardiovascular illness  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Only Lubricating drop  Patients will be treated with only lubricating drop for dry eye disease 
Intervention  Oral zinc supplement with lubricating drop  Oral zinc [50mg] twice daily for three months along with lubricating drop for dry eye disease 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  All young adult patients [18 years to 30 years], presented with dry eye disease and also having concurrent Acne vulgaris and providing written consent for voluntary participation would be recruited for this study. 
 
ExclusionCriteria 
Details  subjects with any known systemic illnesses like diabetes mellitus, thyroid disorders and auto-immune disorders. Subjects with history of smoking, alcohol consumption, or any other drugs like isotretonion, anti-histaminic, anti-cancer and beta-blockers would be excluded. Subjects with Computer work or mobile use of more than four hours in a day would also be excluded from the study. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the clinical efficacy of oral Zinc supplement with the conventional treatment in young adult patients of dry eye disease associated with acne vulgaris.  Two years 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Objectives
• To compare the treatment response in terms of duration of treatment
• To compare the treatment response in terms of fastest clinical response. 		 two years 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   01/08/2025 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [imdrsujitdas@gmail.com].

  6. For how long will this data be available start date provided 05-06-2025 and end date provided 05-12-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Dry eye is an ocular surface disease that is characterized by symptoms including irritation and discomfort of the ocular surface caused by abnormal tear film and ocular surface inflammation. Tear film hyperosmolarity, increased ocular surface staining, ocular surface remodeling and increased inflammation have all been observed in the pathology of dry eye syndromes. Oxidative stress has been reported as one of the mechanisms in dry eyes and normally plays a physiologic role in cell signaling. Excessive oxidative stress damages DNA, RNA, or cell proteins, causing cell death and inducing inflammation.[Dry eye is an ocular surface disease that is characterized by symptoms including irritation and discomfort of the ocular surface caused by abnormal tear film and ocular surface inflammation. Tear film hyperosmolarity, increased ocular surface staining, ocular surface remodeling and increased inflammation have all been observed in the pathology of dry eye syndromes. Oxidative stress has been reported as one of the mechanisms in dry eyes and normally plays a physiologic role in cell signaling. Excessive oxidative stress damages DNA, RNA, or cell proteins, causing cell death and inducing inflammation.

Acne vulgaris is a disease of sebaceous gland and Mebomian gland is a modified sebaceous gland. Androgens represent the most important of all hormones regulating sebum production. As of puberty, androgens stimulate sebum production and acne formation in both sexes.[2]
Zinc is essential for the maintenance of the corneal and conjunctival epithelium. Zn also functions as a modulator of the immune response through its availability. Chronic zinc deficiency increases immune dysfunctions, increased oxidative stress, increased generation of inflammatory cytokines, ocular surface inflammation and delayed wound healing.[3] Zinc also suppresses the proliferation of androgen receptor (AR) and functioned as a negative growth regulator for the AR.

Role of Zinc

1.    Zinc (Zn) is an essential trace element for humans and it is the second most abundant trace metal in humans after iron.

2.    Immune modulators

3.    Anti-inflammatory property

4.    Anti-oxidant property

5.    Healing property of cells epithelium

6.    Anti-androgenic property

SAMPLE SELECTION CRITERIA

Inclusion criteria

All young adult patients [18 years to 30 years], presented with dry eye disease and also having concurrent Acne vulgaris and providing written consent for voluntary participation would be recruited for this study.

Exclusion criteria

A detailed history and clinical examination would be conducted to exclude the subjects with any known systemic illnesses like diabetes mellitus, thyroid disorders and auto-immune disorders. Subjects with history of smoking, alcohol consumption, or any other drugs like isotretonion, anti-histaminic, anti-cancer and beta-blockers would be excluded.  Subjects with Computer work or mobile use of more than four hours in a day would also be excluded from the study.

 

FLOW OF THE STUDY

1. After institute ethical clearance, patients fulfilling the inclusion criteria will be selected.

2. Informed and written consent will be taken

3.  After Randomization:

 

Method of Randomization

We will distribute the patients into two groups randomly.

·         Group I (Standard Treatment): Eye drop Carboxymethyly cellulose 0.5%, 1 drop 4-6 times a day with anti acne medications

·         Group II (Intervention Group I):  Eye drop Carboxymethyly cellulose 0.5%, 1 drop 4-6 times a day plus oral Zinc(50mg) 1 tablet twice daily for 3 months along with anti acne medications.

5. Blinding

The study will be triple blinded. The patient, surgeon, the data collector, as well as data analyzer will be blinded in the study. The surgery will be performed by a single surgeon i.e Principal Investigator, who will also be responsible for data collection.

The nursing officer will load the 3mL syringe with the solution as per the randomization sequence and covered by an opaque surgical tape ensuring triple blinding i.e blinding of the patient, surgeon, data collector, and data analyzer.

6.  Sample size-  60

This would use a convenience sample with defined inclusion and exclusion criteria for this study.

1.    Ophthalmic examination:

All patients will undergo visual acuity, intraocular pressure, colour vision, fundus examination, Schirmer I & II, TBUT, TFH and corneal fluorescin staining score [FSS score] to see ocular surface changes. Longer TBUT represents the stable tear film and shorter TBUT is considered as the unstable tear film. FSS is defined as the degree of punctate keratitis and higher score is considered as more severe FSS. Eyelid margin hyperemia indicates the inflammation of eyelid and higher score represents the inflammation of eyelid. Tear secretion will be measured using the Schirmer strip test with (II) and without anesthesia (I). A fine strip paper was placed inside the lower conjunctival sac and the wet part will be measured. A modified standardized patient evaluation of eye dryness (SPEED) questionnaire will be used to assess the frequency and severity of each symptom, including dryness, foreign body sensation (FBS), coldness, eye fatigue, pain, and photophobia for frequency of symptoms. The SPEED questionnaire was scored for both frequency of symptoms (0 = no symptoms, 1 = sometimes, 2 = often, and 3 = constant) and severity of symptom/impact on daily life (0 = no symptoms, 1 = tolerable but not uncomfortable, 2 = uncomfortable but does not interfere with my day, 3 = bothersome and interferes with my day, and 4 = intolerable and unable to perform my daily tasks).

Visual analogue pain scale (VAS) will be used to asses to measure ocular pain intensity [where 0 = no discomfort and 10 = maximal discomfort]. The survey will be conducted using the ocular surface disease index (OSDI) questionnaire. OSDI was calculated after patient OSDI questionnaire completion for measuring dry eye symptoms severity. OSDI is scored on a scale of 0–100 with greater scores representing greater disability.

 

9.  Follow-up will be done on second week, fourth week and after second & third months.

10. Review of data and data analysis

11. Result calculation

 
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