Vitamin B Complex as Adjunct Therapy for Moderate-to-Severe Dry Eye Disease
NCT07919223, Not applicable, Completed, Rania Fahmy
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Vitamin B Complex as Adjunct Therapy for Moderate-to-Severe Dry Eye Disease | ClinicalTrials.gov |
| NCT number | NCT07919223 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 56 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Rania Fahmy | ClinicalTrials.gov |
| Conditions | Dry Eye Disease, Dry Eye | ClinicalTrials.gov |
| Interventions | Carboxymethylcellulose Sodium 0.5% Eye Drops, Vitamin B Complex | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Ocular Surface Disease Index (OSDI) Score | Baseline and 2 months | 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 | ClinicalTrials.gov |
| Secondary | Change in Tear Meniscus Height (TMH) | Baseline and 2 months | 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 | ClinicalTrials.gov |
| Secondary | Change in Non-Invasive Keratograph Tear Break-Up Time (NIK-TBUT) | Baseline and 2 months | 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. | ClinicalTrials.gov |
| Secondary | Change in Fluorescein Tear Break-Up Time (fTBUT) | Baseline and 2 months | 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. | ClinicalTrials.gov |
| Secondary | Change in Schirmer Test Score | Baseline and 2 months | 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. | ClinicalTrials.gov |
| Secondary | Patient Treatment Satisfaction | 2 months | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)