An interventional study of Carboxymethylcellulose Sodium 0.5% Eye Drops and Vitamin B Complex in Dry Eye Disease and Dry Eye, sponsored by Rania Fahmy. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Rania Fahmy · Not applicable, Interventional, and Treatment
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.
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:
Clinical assessments were performed at baseline and after two months. Outcome measures included:
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.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 56 is close to the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with Rania Fahmy as lead sponsor.
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Exclusion Criteria:
Presence of corneal disease
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received preservative-free artificial tears (Refresh Plus®, 0.5% carboxymethylcellulose) four times daily for two months.
Drug: Carboxymethylcellulose Sodium 0.5% Eye Drops
Participants 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.
Drug: Carboxymethylcellulose Sodium 0.5% Eye Drops · Dietary Supplement: Vitamin B Complex
Preservative-free artificial tears, one drop in each eye four times daily for two months.
Oral tablet containing thiamine 200 mg, pyridoxine 50 mg, and cyanocobalamin 1 mg, taken once daily for two months.
Change in Ocular Surface Disease Index (OSDI) Score
The Ocular Surface Disease Index (OSDI) is a validated 12-item questionnaire used to assess dry eye symptoms and their impact on vision-related functioning. The total score ranges from 0 to 100, with 0 representing no symptoms and 100 representing the most severe symptoms. Higher scores indicate greater dry eye disease severity and worse outcomes. The conventional OSDI severity categories are: * 0-12: Normal * 13-22: Mild * 23-32: Moderate * 33-100: Severe
Time frame: Baseline and 2 months
Change in Tear Meniscus Height (TMH)
Change in Tear Meniscus Height (TMH), measured in millimeters (mm), from baseline to the specified follow-up assessment. TMH is an objective indicator of tear volume. Higher TMH values generally indicate greater tear volume and are considered a favorable outcome in patients with aqueous-deficient dry eye disease. The measurement is recorded as a continuous variable. No fixed minimum or maximum values are specified for this outcome measure. Higher values Generally indicate greater tear volume and a better outcome Outcome calculation Follow-up TMH minus baseline TMH
Time frame: Baseline and 2 months
Change in Non-Invasive Keratograph Tear Break-Up Time (NIK-TBUT)
Non-Invasive Keratograph Tear Break-Up Time (NIK-TBUT), measured in seconds (s), from baseline to the specified follow-up assessment. NIK-TBUT is an objective measure of tear film stability, determined using a non-invasive keratograph. The measurement is recorded as a continuous variable. Higher values indicate longer tear film stability and generally represent a better clinical outcome. No fixed minimum or maximum values are specified for this measurement.
Time frame: Baseline and 2 months
Change in Fluorescein Tear Break-Up Time (fTBUT)
Fluorescein Tear Break-Up Time (fTBUT), measured in seconds (s), from baseline to the specified follow-up assessment. fTBUT is an objective clinical measure of tear film stability, determined by measuring the time elapsed between fluorescein instillation and the appearance of the first break in the tear film. The measurement is recorded as a continuous variable. Higher values indicate greater tear film stability and generally represent a better clinical outcome. No fixed minimum or maximum values are specified for this measurement.
Time frame: Baseline and 2 months
Change in Schirmer Test Score
Schirmer Test, measured in millimeters (mm) of wetting of the standardized filter paper strip over 5 minutes, from baseline to the specified follow-up assessment. The Schirmer test is an objective measure of aqueous tear production. The measurement is recorded as a continuous variable, with values typically ranging from 0 to 35 mm over 5 minutes, depending on the test strip and measurement protocol. Higher values indicate greater tear production and generally represent a better clinical outcome in patients with aqueous-deficient dry eye disease.
Time frame: Baseline and 2 months
Patient Treatment Satisfaction
Patient Treatment Satisfaction was assessed using a patient-reported satisfaction scale at the specified follow-up assessment. The score reflects the participant's overall satisfaction with the assigned treatment. Higher scores indicate greater treatment satisfaction and a more favorable patient-reported outcome. The minimum and maximum possible scores depend on the scale used.
Time frame: 2 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Vitamin B Complex