Trial · NCT04567329
Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)
NCT04567329, Phase 3, Completed, Bausch & Lomb Incorporated; results first posted 2024-08-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study). Trials, record NCT04567329. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04567329
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)
- NCT number
- NCT04567329
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 620 participants, actual
- Lead sponsor
- Bausch & Lomb Incorporated
- Conditions
- Dry Eye Disease
- Interventions
- NOV03, Saline Solution
- First posted
- 2020-09-28
- Last updated
- 2024-08-19
- Results first posted
- 2024-08-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Corneal Fluorescein Staining Score (NEI Scale) in the Study Eye at Day 57 | Assessed at Day 57 | The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section). |
| Primary | Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 57 | Assessed at Day 57 | Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness"). |
| Secondary | Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 15 | Assessed at Day 15 | Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness"). |
| Secondary | Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) at Day 15 | Assessed at Day 15 | The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total of 15 points (sum of scores for each section). |
| Secondary | Change From Baseline in Burning/Stinging (Visual Analogue Scale [VAS] Severity of Burning/Stinging) at Day 57 | Assessed at Day 57 | Subjects will be asked about the severity of burning / stinging. Study staff will ask subjects to rate their ocular symptoms (both eyes simultaneously) due to ocular dryness by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no discomfort" and 100% corresponds to "maximal discomfort"). |
| Secondary | Change From Baseline in Central Corneal Fluorescein Staining (NEI Scale) at Day 57 | Assessed at Day 57 | The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum of 3 points in the central section. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Corneal Fluorescein Staining Score (NEI Scale) in the Study Eye at Day 57 | Assessed at Day 57 | units on a scale | MEAN | |
| PRIMARY | Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 57 | Assessed at Day 57 | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 15 | Assessed at Day 15 | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) at Day 15 | Assessed at Day 15 | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in Burning/Stinging (Visual Analogue Scale [VAS] Severity of Burning/Stinging) at Day 57 | Assessed at Day 57 | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in Central Corneal Fluorescein Staining (NEI Scale) at Day 57 | Assessed at Day 57 | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining Score (NEI Scale) in the Study Eye at Day 57 | NOV03 | -2.3 | Standard Deviation 2.8 | units on a scale | |
| Change From Baseline in Total Corneal Fluorescein Staining Score (NEI Scale) in the Study Eye at Day 57 | Saline Solution | -1.1 | Standard Deviation 2.9 | units on a scale | |
| Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 57 | NOV03 | -29.5 | Standard Deviation 28.6 | units on a scale | |
| Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 57 | Saline Solution | -19.0 | Standard Deviation 27.2 | units on a scale | |
| Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 15 | NOV03 | -18.5 | Standard Deviation 23.6 | units on a scale | |
| Change From Baseline in Dryness Score (Visual Analogue Scale [VAS] Severity of Dryness) at Day 15 | Saline Solution | -10.5 | Standard Deviation 23.9 | units on a scale | |
| Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) at Day 15 | NOV03 | -1.9 | Standard Error 2.3 | units on a scale | |
| Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) at Day 15 | Saline Solution | -1.3 | Standard Error 2.4 | units on a scale | |
| Change From Baseline in Burning/Stinging (Visual Analogue Scale [VAS] Severity of Burning/Stinging) at Day 57 | NOV03 | -22.1 | Standard Deviation 27.5 | units on a scale | |
| Change From Baseline in Burning/Stinging (Visual Analogue Scale [VAS] Severity of Burning/Stinging) at Day 57 | Saline Solution | -13.7 | Standard Deviation 29.9 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NOV03 | 311 | |
| Overall Study | STARTED | Saline Solution | 309 | |
| Overall Study | COMPLETED | NOV03 | 302 | |
| Overall Study | COMPLETED | Saline Solution | 296 | |
| Overall Study | NOT COMPLETED | NOV03 | 9 | |
| Overall Study | NOT COMPLETED | Saline Solution | 13 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| other | Eye disorder | Eye disorders | NOV03 | 16 | 311 | |
| other | Eye disorder | Eye disorders | Saline Solution | 16 | 309 | |
| other | Hyperaemia | Vascular disorders | NOV03 | 0 | 311 | |
| other | Hyperaemia | Vascular disorders | Saline Solution | 3 | 309 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NOV03 | 0 | 311 |
| Total, all-cause mortality | Saline Solution | 0 | 309 |
| Total, other adverse events | NOV03 | 16 | 311 |
| Total, other adverse events | Saline Solution | 19 | 309 |
| Total, serious adverse events | NOV03 | 0 | 311 |
| Total, serious adverse events | Saline Solution | 0 | 309 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NOV03 vs Saline Solution: deaths from any cause | Trial comparisons |
| NOV03 vs Saline Solution: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04567329
GET https://conductscience.org/api/trials/v1/NCT04567329/registered