ClinicalTrials.gg
Active, not recruitingNCT06913465Updated Apr 6, 2025

The Impact of Hypothyroidism on Tear Production and Dry Eye Symptoms: Implications for Optometric Care

An observational study in Dry Eye Syndromes, sponsored by Superior University. Active, not recruiting at 2 sites in Pakistan. Open to female participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-06.

Sponsored by Superior University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
64
Ages
20 Years to 60 Years
Sex
Female
01

Study summary

This observational cross-sectional study will assess the impact of hypothyroidism on tear production and tear film stability. Conducted at DHQ Hospital dera ghazi khan over six months, the study will recruit 71 participants aged 20-60 years using a non-probability convenience sampling method. Patients with confirmed hypothyroidism will undergo tear assessment through the Schirmer I test, Tear Breakup Time (TBUT) test, and Ocular Surface Disease Index (OSDI) questionnaire. The Schirmer test will measure tear production, while TBUT will assess tear film stability.

Read the detailed description

Ocular surface staining and tear osmolarity will further evaluate ocular health. Patients with systemic conditions affecting tear production, such as diabetes or rheumatoid arthritis, will be excluded. The collected data will be analyzed to determine the relationship between hypothyroidism and dry eye symptoms, aiding in better management of ocular health in hypothyroid patients. The study aims to provide valuable insights into the association between thyroid dysfunction and tear film abnormalities.

02

Conditions studied

  • Dry Eye Syndromes

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03

In context

Dry Eye Syndromes

1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.

This study's enrollment of 64 is below the median of 89 across 176 observational studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Superior University is the lead sponsor of 253 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This observational cross-sectional study will assess the impact of hypothyroidism on tear production and tear film stability. Conducted at DHQ Hospital dera ghazi khan over six months, the study will recruit 71 participants aged 20-60 years using a non-probability convenience sampling method. Patients with confirmed hypothyroidism will undergo tear assessment through the Schirmer I test, Tear Breakup Time (TBUT) test, and Ocular Surface Disease Index (OSDI)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 20-60 years.
  • Confirmed diagnosis of hypothyroidism with thyroid function tests.
  • No prior history of ocular surgery or significant ocular pathology.

Exclusion criteria

Exclusion Criteria:

  • Use of systemic medications affecting tear production (e.g., antihistamines, diuretics).
  • Other systemic conditions (e.g., diabetes, rheumatoid arthritis).
  • Pregnancy or lactation
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
64 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The Ocular Surface Disease Index (OSDI)

    The Ocular Surface Disease Index (OSDI) is a 12-question questionnaire used to assess the severity of dry eye symptoms and their impact on vision-related function, scored on a scale of 0 to 100, with higher scores indicating greater disability.

    Time frame: 12 Months

07

Study locations

2 sites
  • DHQ Hospital
    Dera Ghazi Khan, Punjab Province, Pakistan
  • CENUM Center Mayo Hospital Rd, Anarkali Bazaar
    Lahore, Punjab Province 54000, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2025 (actual). Primary completion is estimated for Jun 2025, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2025
First posted
Apr 6, 2025
StartActual
Mar 20, 2025
Primary completionEst.
Jun 20, 2025
CompletionEst.
Feb 20, 2026
Last update
Apr 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06913465
Responsible party
Muhammad Naveed Babur (Principal Investigator, Superior University) — Principal investigator
First posted
Apr 6, 2025
Start date
Mar 20, 2025
Primary completion
Jun 20, 2025 (estimated)
Completion
Feb 20, 2026 (estimated)
Last update
Apr 6, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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