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Dry Eye DiseaseNCT07919223

Vitamin B Complex as Adjunct Therapy for Moderate-to-Severe Dry Eye Disease

A study testing Carboxymethylcellulose Sodium 0.5% Eye Drops and Vitamin B Complex in people with Dry Eye Disease and Dry Eye, run by Rania Fahmy at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized controlled trial evaluated whether adding an oral vitamin B complex (thiamine, pyridoxine, and cyanocobalamin) to preservative-free artificial tears improves signs and symptoms of moderate-to-severe dry eye disease more than artificial tears alone. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Dry Eye Disease, Dry Eye
What is being tested?
Carboxymethylcellulose Sodium 0.5% Eye Drops and Vitamin B Complex
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteSaudi Arabia
Study dates
1 Jan 2023to 30 Jun 2023
Phase
Interventional
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adults aged 18 to 60 years
  • Male or female
  • Diagnosis of moderate-to-severe dry eye disease defined as:
  • Tear Break-Up Time (TBUT) ≤ 10 seconds
  • Schirmer test < 10 mm/5 minutes
  • Willing and able to provide written informed consent
  • Willing to comply with study procedures and follow-up visits

Who cannot join

  • Presence of corneal disease
  • History of refractive surgery
  • Current contact lens wear
  • Glaucoma
  • Diabetic retinopathy
  • Optic neuropathy
Show all 12Show fewer
  • Uveitis
  • Current chemotherapy or radiotherapy
  • Current use of systemic corticosteroids or immunomodulatory agents
  • Current use of antihistamines
  • Any ongoing treatment for dry eye disease
  • Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • College of Applied Medical Sciences Clinics, King Saud University

    Riyadh

Other trials in Saudi Arabia

About this study

Official title: Vitamin B Complex as a Therapeutic Adjunct for Moderate-to-Severe Dry Eye Disease in Otherwise Healthy Subjects: A Randomized Controlled Trial

This randomized controlled trial evaluated whether adding an oral vitamin B complex (thiamine, pyridoxine, and cyanocobalamin) to preservative-free artificial tears improves signs and symptoms of moderate-to-severe dry eye disease more than artificial tears alone. Adults aged 18-60 years with moderate-to-severe dry eye were randomly assigned to receive either artificial tears four times daily (control group) or the same artificial tears plus a once-daily vitamin B complex tablet for two months. The main outcomes measured were symptom scores (OSDI), tear meniscus height, tear break-up time, and Schirmer test results. The study was conducted at King Saud University in Riyadh, Saudi Arabia.

Read the detailed description

Dry eye disease is a common multifactorial condition of the ocular surface characterized by tear film instability, hyperosmolarity, and inflammation. B-complex vitamins (especially vitamins B1, B6, and B12) act as coenzymes in neuronal and cellular metabolism and may support ocular surface health and reduce neuropathic ocular pain.

This prospective, randomized controlled trial was conducted at the College of Applied Medical Sciences Clinics, King Saud University, between January and June 2023. Eligible participants were adults aged 18-60 years with moderate-to-severe dry eye disease (tear break-up time ≤ 10 seconds and Schirmer test < 10 mm/5 min). Exclusion criteria included corneal disease, previous refractive surgery, contact lens wear, glaucoma, diabetic retinopathy, optic neuropathy, uveitis, current use of corticosteroids, immunomodulatory agents, antihistamines, or any ongoing dry eye treatment.

Participants were randomly assigned to one of two groups:

  • Group A (Control): Preservative-free artificial tears (Refresh Plus®, 0.5% carboxymethylcellulose) four times daily for two months.
  • Group B (Treatment): The same artificial tears plus one daily oral tablet of vitamin B complex (Neurorubine®: thiamine 200 mg, pyridoxine 50 mg, cyanocobalamin 1 mg) for two months.

Clinical assessments were performed at baseline and after two months. Outcome measures included:

  • Ocular Surface Disease Index (OSDI) score
  • Tear meniscus height (TMH)
  • Non-invasive keratograph tear break-up time (NIK-TBUT)
  • Fluorescein tear break-up time (fTBUT)
  • Schirmer test (without anesthesia)
  • Patient treatment satisfaction questionnaire

A total of 56 participants (28 per group) completed the study. Both groups showed significant improvement in OSDI scores. The combined therapy group demonstrated superior improvements in tear meniscus height and non-invasive tear break-up time compared with artificial tears alone.

Being tested
Carboxymethylcellulose Sodium 0.5% Eye Drops, Vitamin B Complex
Keywords
dry eye disease, Vitamin B complex, Thiamine, Tear Break up time
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carboxymethylcellulose Sodium 0.5% Eye DropsDrug

    Preservative-free artificial tears, one drop in each eye four times daily for two months.

  • Vitamin B ComplexDietary supplement

    Oral tablet containing thiamine 200 mg, pyridoxine 50 mg, and cyanocobalamin 1 mg, taken once daily for two months.

Study groups in NCT07919223
Study groupRoleWhat they receive
Artificial Tears Alone (Control)Active comparatorParticipants received preservative-free artificial tears (Refresh Plus®, 0.5% carboxymethylcellulose) four times daily for two months.
Receives: Drug: Carboxymethylcellulose Sodium 0.5% Eye Drops; Dietary Supplement: Vitamin B Complex
Artificial Tears + Vitamin B ComplexExperimentalParticipants received preservative-free artificial tears (Refresh Plus®, 0.5% carboxymethylcellulose) four times daily plus one daily oral tablet of vitamin B complex (Neurorubine®) for two months.
Receives: Dietary Supplement: Vitamin B Complex

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Ocular Surface Disease Index (OSDI) Score

    OSDI is a 12-item questionnaire that assesses dry eye symptoms and their impact on vision-related function. Scores range from 0 to 100, with higher scores indicating greater severity of dry eye symptoms.

    Measured: Baseline and 2 months

Secondary outcomes (5)

  1. Change in Tear Meniscus Height (TMH)

    Tear meniscus height measured in millimeters using the Keratograph 4. Higher values indicate better tear volume.

    Measured: Baseline and 2 months

  2. Change in Non-Invasive Keratograph Tear Break-Up Time (NIK-TBUT)

    Non-invasive tear break-up time measured in seconds using the Keratograph 4. Longer times indicate better tear film stability.

    Measured: Baseline and 2 months

  3. Change in Fluorescein Tear Break-Up Time (fTBUT)

    Fluorescein tear break-up time measured in seconds. Longer times indicate better tear film stability.

    Measured: Baseline and 2 months

  4. Change in Schirmer Test Score

    Schirmer test without anesthesia, measured in millimeters of wetting after 5 minutes. Higher values indicate better aqueous tear production.

    Measured: Baseline and 2 months

  5. Patient Treatment Satisfaction

    Patient-reported satisfaction with treatment effectiveness and symptom relief, assessed using a treatment satisfaction questionnaire at the end of the study.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start1 Jan 2023
  3. Primary completion30 Jun 2023
  4. Study completion30 Jun 2023

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants were randomly assigned to one of two parallel groups.
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07919223
Sponsor's protocol ID
E-22-7212
Other IDs
E-22-7212
Status last verified
Oct 2026
First submitted
31 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Carboxymethylcellulose Sodium 0.5% Eye Drops and Vitamin B Complex in people with Dry Eye Disease and Dry Eye, run by Rania Fahmy at 1 site in Saudi Arabia.

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 7 inclusion and 12 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 5 Nov 2026. 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 Saudi Arabia. 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.

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?

Change in Ocular Surface Disease Index (OSDI) Score (time frame: Baseline and 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07919223.

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 5 Nov 2026.

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