Dry Eye SyndromesPhase 3NCT05425914
Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level
A Phase 3 study testing Vitamin D and Artificial tear in people with Dry Eye Syndromes and Hypovitaminosis D, run by University of Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Dry Eye Syndromes, Hypovitaminosis D
- What is being tested?
- Vitamin D and Artificial tear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2021to 30 Apr 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Autoimmune 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dry Eye Syndromes, Hypovitaminosis D
- Being tested
- Vitamin D, Artificial tear
- Keywords
- Artificial tears., Dry eye syndrome., vitamin d deficiency.
- Medical subject headings
- Dry Eye Syndromes, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
New treatment option for dry eye patients with low serum vitamin D Level
Artificial tearDrug
Conventional dry eye treatment
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment | Active comparator | Receiving conventional dry eye treatment in the form of artificial tears four times per days for 90 days. Receives: Drug: Artificial tear |
| Vitamin D3 Supplementation | Experimental | Receiving vitamin d3 supplementation 6000IU per day along with artificial tears for 90 days. Receives: Drug: Vitamin D; Drug: Artificial tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Breakup time in seconds
Improvement after vitamin D3 supplementation over a period of time
Measured: 90 days
Schirmer test score in millimeters
Improvement after vitamin D3 supplementation over a period of time
Measured: 90 days
Secondary outcomes (2)
Ocular surface disease index score in units
Change in both groups after treatment. Values ranges from 0 to 100. Higher score indicates worse condition.
Measured: 90 days
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Nov 2021
- Primary completion15 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bushra Kanwal, University of Faisalabad
- Investigators
- Bushra Kanwal, MPO, Principal investigator, The University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425914
- Sponsor's protocol ID
- TUF Faisalabad
- Status last verified
- Jun 2022
- First submitted
- 11 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to share results only due to confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D3 Supplementation in Non-Sjogren Dry Eye Patients With Low Serum Vitamin D Level
- ClinicalTrials.gov ID
- NCT05425914
- Acronym / sponsor ID
- TUF Faisalabad
- Conditions
- Dry Eye Syndromes, Hypovitaminosis D
- Keywords
- Artificial tears., Dry eye syndrome., vitamin d deficiency.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment | Active comparator | Drug: Artificial tearReceiving conventional dry eye treatment in the form of artificial tears four times per days for 90 days. |
| Vitamin D3 Supplementation | Experimental | Drug: Vitamin D, Drug: Artificial tearReceiving vitamin d3 supplementation 6000IU per day along with artificial tears for 90 days. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Autoimmune 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DNew treatment option for dry eye patients with low serum vitamin D Level | Drug | Vitamin D3 Supplementation |
| Artificial tearConventional dry eye treatment | Drug | Conventional Treatment, Vitamin D3 Supplementation |
Primary outcome
Tear Breakup time in seconds
Time frame: 90 days
Improvement after vitamin D3 supplementation over a period of time
Schirmer test score in millimeters
Time frame: 90 days
Improvement after vitamin D3 supplementation over a period of time
2 secondary outcomes
Ocular surface disease index score in units
Time frame: 90 days
Numerical Pain Rating Scale
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: No. Plan to share results only due to confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bushra Kanwal, MPO principal investigator
The University of Faisalabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D and Artificial tear in people with Dry Eye Syndromes and Hypovitaminosis D, run by University of Faisalabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Breakup time in seconds (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.