ClinicalTrials.gg
CompletedNCT05425914Updated Jun 21, 2022

Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level

A Phase 3 interventional study of Vitamin D and Artificial tear in Dry Eye Syndromes and Hypovitaminosis D, sponsored by University of Faisalabad. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by University of Faisalabad · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Nov 2021, registered Jun 2022).
Phase
Phase 3
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Dry Eye Syndromes with a site in Pakistan — none open to participants now, 9 under way, none of them phase 3. Dry Eye Syndromes · Pakistan.

Enrollment
3rd of 11
108 · median 64
Started
2021
with 2 others
Phase 3
Only one
of the 14
Registered
4th of 14
by date
Lead sponsor
3 of 14
University of Faisalabad

Among the 14 studies in Dry Eye Syndromes with a site in Pakistan, this one is the 3rd largest by enrollment of the 11 interventional ones that give a count, is one of 3 that started in 2021, is the only one in phase 3, and was the 4th registered.

Dry Eye Syndromes

1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.

Browse Dry Eye Syndromes studies →

Open to participants now

None of the 14 studies in Dry Eye Syndromes with a site in Pakistan is open now. The open studies under Dry Eye Syndromes, anywhere →

Who these studies take

Of the 116 Dry Eye Syndromes studies recruiting now, 73 (63%) set no upper age limit and 24 (21%) stop at 75 or younger; 7 take children under 18; 29 take healthy volunteers.

This study: 20 Years to 50 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 14 studies in Dry Eye Syndromes with a site in Pakistan as a file.
02

Study summary

Dry eye disease is multifactorial, ocular inflammatory condition causing irritation, stinging sensation, uneasiness and blurring. Non-Sjogren syndrome occurs due to absent or dysfunction of lacrimal gland. Fat soluble vitamin D act as an agent against inflammation and its deficiency may result in various inflammatory diseases including dry eye. Purpose of this study is evaluation of vitamin D3 supplementation role in treating non-Sjogren dry eye along with conventional treatment by using artificial tears in patients with hypovitaminosis D. A prospective study was conducted in Rural health center(RHC) Buchal Kalan on 108 patients presenting with non-Sjogren dry eyes and low serum vitamin D levels. Patients were subjected to the following examination; best corrected visual acuity (BCVA), slit-lamp examination, applanation tonometry, fundoscopy, tear breakup time (TBUT) after fluorescein staining, Schirmer tear test, numerical pain rating scale (NPRS) and ocular surface disease index (OSDI) score on day 0, 15, 30, 60 and 90. Vitamin D levels was assessed by electrochemiluminescence immunoassay (ECLIA) based analyzer. The sample was randomly divided into two groups by non-probability purposive sampling. Group 1 received only artificial tears 4times/day while group 2 were given oral vitamin D3 supplementation of 6000 international unit (IU) daily along with artificial tears. Impact of oral vitamin D3 supplementation on non-Sjogren dry eyes was assessed by comparing means of ocular parameters of both groups over different period of time by using Mann-Whitney Test and Friedman Test.

03

Conditions studied

  • Dry Eye Syndromes
  • Hypovitaminosis D

Keywords

  • Artificial tears.
  • Dry eye syndrome.
  • vitamin d deficiency.
04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Patients with non-Sjogren dry eyes with low serum vitamin D level.
  • Both gender.
  • Age group will be 20-50 years of age.
  • Cooperative patients.

Exclusion criteria

Exclusion Criteria:

  • diseases (such as Sjogren syndrome and lupus syndrome).
  • All ocular pathologies except dry eyes.
  • All systemic pathologies that affects tear layers.
  • All non- cooperative patients.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • Active comparator
    Conventional Treatment

    Receiving conventional dry eye treatment in the form of artificial tears four times per days for 90 days.

    Drug: Artificial tear

  • Experimental
    Vitamin D3 Supplementation

    Receiving vitamin d3 supplementation 6000IU per day along with artificial tears for 90 days.

    Drug: Vitamin D · Drug: Artificial tear

Interventions

  • New treatment option for dry eye patients with low serum vitamin D Level

  • Conventional dry eye treatment

06

What researchers measure

Primary outcomes

  1. Tear Breakup time in seconds

    Improvement after vitamin D3 supplementation over a period of time

    Time frame: 90 days

  2. Schirmer test score in millimeters

    Improvement after vitamin D3 supplementation over a period of time

    Time frame: 90 days

Secondary outcomes

  1. Ocular surface disease index score in units

    Change in both groups after treatment. Values ranges from 0 to 100. Higher score indicates worse condition.

    Time frame: 90 days

  2. Numerical Pain Rating Scale

    Change in both groups after treatment. Values ranges from 0 to 10 wher 0 indicates no pain while 10 indicates worst pain

    Time frame: 90 days

07

Study locations

1 site
  • RHC Buchal Kalan
    Chakwal, Punjab 48800, Pakistan
08

References and documents

Individual participant data

Plan to share: No — Plan to share results only due to confidentiality

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Mar 2022, 4 months.

Of 96 phase 3 interventional studies under Dry Eye Syndromes, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 15. This study's 4 months is below that.

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

Registered
Jun 11, 2022
First posted
Jun 21, 2022
StartActual
Nov 1, 2021
Primary completionActual
Mar 15, 2022
CompletionActual
Apr 30, 2022
Last update
Jun 21, 2022
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 Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05425914
Lead sponsor
University of Faisalabad
Responsible party
Bushra Kanwal (Principal Investigator, University of Faisalabad) — Principal investigator
First posted
Jun 21, 2022
Start date
Nov 1, 2021
Primary completion
Mar 15, 2022
Completion
Apr 30, 2022
Last update
Jun 21, 2022

Study contacts

Bushra Kanwal, MPO
principal investigator · The University of Faisalabad

Oversight

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

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Vitamin D

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