| CTRI Number |
CTRI/2026/03/106519 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational Cross Sectional Comparative Analytical Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of low and high mineral drinking water on tear film stability and eye surface health in adults |
|
Scientific Title of Study
|
Comparison of Tear Film Stability and Ocular Surface Health Between Low TDS and High TDS Drinking Water Consumers |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ratan Lal Rastogi |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University |
| Address |
Department of Optometry, Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9918062004 |
| Fax |
|
| Email |
ratanlalrastogi351@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Partha Chowdhury |
| Designation |
Professor Optometry |
| Affiliation |
Galgotias University |
| Address |
E 002, Department of Optometry, Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9456771714 |
| Fax |
|
| Email |
partha.chowdhury@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Partha Chowdhury |
| Designation |
Professor Optometry |
| Affiliation |
Galgotias University |
| Address |
E 002, Department of Optometry, Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9456771714 |
| Fax |
|
| Email |
partha.chowdhury@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Plot No. 2, Yamuna Expressway, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh |
| Type of Sponsor |
Research institution |
|
|
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 |
| Ratan Lal Rastogi |
Community Health Centre |
Gate number 2 Room Number 3 Department of Optometry Dighal NH-71, Dighal, District Jhajjar, 124107
Jhajjar
HARYANA |
9918062004
ratanlalrastogi351@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| NOC CHC DIGHAL |
Approved |
| School Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ocular surface health and tear film stability among adults consuming different tds levels of drinking water |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High Total Dissolved Solids Drinking Water greater than or equal to 500 ppm |
Individuals consuming household drinking water with Total Dissolved Solids greater than 500 parts per million for at least six months. Participants will undergo ocular surface evaluation including Tear Break Up Time, Schirmer I test, and corneal and conjunctival staining to assess tear film stability.
Participants are not assigned to any intervention. Groups are defined based on the natural Total Dissolved Solids level of their household drinking water. |
| Comparator Agent |
Low Total Dissolved Solids Drinking Water less than or equal to 300 ppm |
Individuals consuming household drinking water with Total Dissolved Solids less than 300 parts per million for at least six months. Participants will undergo ocular surface evaluation including Tear Break Up Time, Schirmer I test, and corneal and conjunctival staining to assess tear film stability. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 25 to 50 years
Individuals consuming the same primary household drinking water source for at least 6 months
Participants willing to provide a household drinking water sample for Total Dissolved Solids (TDS) measurement
Individuals whose drinking water TDS falls into the study categories: Low-TDS (less than 300 ppm) or High-TDS (greater than 500 ppm)
Participants able to undergo ocular surface evaluation including Tear Break-Up Time (TBUT), Schirmer’s I test, and corneal and conjunctival staining and complete the OSDI questionnaire
Individuals with no active ocular infection or ocular allergy at the time of enrolment
Participants willing and able to provide written informed consent and comply with study procedures |
|
| ExclusionCriteria |
| Details |
History of ocular surgery or ocular trauma within the past 6 months
Presence of active ocular infection, inflammation, or significant ocular allergy at the time of screening (e.g., conjunctivitis, keratitis, uveitis)
Presence of ocular surface diseases other than dry eye that may affect tear film assessment (e.g., pterygium involving the cornea, severe blepharitis, meibomian gland dysfunction)
Current use of topical ocular medications (including lubricants, steroids, antibiotics, or anti-glaucoma medications) within the past 4 weeks
Contact lens users currently or within the past 1 month
History of systemic autoimmune diseases affecting tear production such as Sjögren’s syndrome, rheumatoid arthritis, or other autoimmune disorders
Individuals taking systemic medications known to affect tear secretion (e.g., antihistamines, antidepressants, anticholinergics, isotretinoin, or long-term diuretics)
Uncontrolled systemic diseases that may influence tear film physiology (e.g., uncontrolled diabetes mellitus)
History of radiotherapy or chemotherapy
Pregnant or lactating women
Individuals with inconsistent drinking water sources or frequent change of drinking water source within the past 6 to 12 months
Participants unwilling or unable to provide a drinking water sample or written informed consent, or unable to cooperate with ocular surface tests (TBUT, Schirmer’s I, OSDI) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Tear Film Break-Up Time (TBUT) measured using fluorescein dye under slit-lamp biomicroscopy to assess tear film stability in participants consuming low-TDS and high-TDS drinking water. |
Baseline (single visit assessment)(at the time of ocular examination) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ocular Surface Disease Index (OSDI) Score
Assessment of dry eye symptoms using validated OSDI questionnaire. |
Baseline (single visit assessment)(at the time of ocular examination) |
Schirmer’s Test I
Measurement of aqueous tear production using Schirmer strips (mm wetting in 5 minutes). |
Baseline (single visit assessment)(at the time of ocular examination) |
Corneal and Conjunctival Fluorescein Staining Score
Evaluation of ocular surface epithelial damage using fluorescein staining grading. |
Baseline (single visit assessment)(at the time of ocular examination) |
Household Drinking Water TDS Level
Measurement of Total Dissolved Solids (ppm) in participants’ household drinking water samples. |
Baseline (single visit assessment)(at the time of ocular examination) |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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 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 - NO
|
|
Brief Summary
|
Dry eye disease is a multifactorial disorder of the ocular surface characterized by tear film instability, ocular discomfort, and potential damage to the ocular surface. Environmental and systemic factors may influence the stability and quality of the tear film. Total Dissolved Solids (TDS) in drinking water represent the concentration of dissolved minerals and salts, which may affect systemic electrolyte balance and potentially influence ocular surface physiology. This comparative cross-sectional observational study aims to evaluate the association between drinking water TDS levels and tear film stability as well as ocular surface health. Participants aged 25 to 50 years who have been consuming the same household drinking water source for at least six months will be included in the study. Household drinking water samples will be collected and analyzed for TDS levels, and participants will be categorized into low-TDS (less than 300 ppm) and high-TDS (greater than 500 ppm) groups. Ocular surface assessment will include Tear Break-Up Time (TBUT), Schirmer’s I test, corneal and conjunctival fluorescein staining, and the Ocular Surface Disease Index (OSDI) questionnaire. In addition, serum electrolyte levels will be measured to explore possible correlations between systemic electrolyte status and ocular surface parameters. The study aims to identify whether differences in drinking water mineral content are associated with variations in tear film stability and ocular surface health. |