Trial · NCT04735393
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
NCT04735393, Phase 3, Completed, Aldeyra Therapeutics, Inc.; results first posted 2025-11-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease. Trials, record NCT04735393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04735393
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
- NCT number
- NCT04735393
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 757 participants, actual
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Conditions
- Dry Eye Disease
- Interventions
- Reproxalap Ophthalmic Solution (0.25%), Placebo Comparator, Reproxalap Ophthalmic Solution (0.25%), Placebo Comparator
- First posted
- 2021-02-03
- Last updated
- 2025-11-26
- Results first posted
- 2025-11-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease | Safety assessment period (six weeks) | The proportion of 6-week safety population subjects that experience at least one visual acuity TE-SAE decrease (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article. |
| Primary | TE-SAEs of Increase in Intraocular Pressure | Safety assessment period (six weeks) | The proportion of 6-week safety population subjects that experience at least one intraocular pressure TE-SAE (increase from baseline of greater than or equal to 10 mmHg and intraocular pressure of greater than 25 mmHg) categorized as probably or definitely related to test article. |
| Primary | TE-SAEs of the Cornea | Safety assessment period (six weeks) | The proportion of 6-week safety population subjects that experience at least one cornea-related TE-SAE (detected via slit-lamp examination) categorized as probably or definitely related to test article. |
| Primary | TE-SAEs of the Retina | Safety assessment period (six weeks) | The proportion 6-week safety population subjects that experience at least one retinal TE-SAE (detected via fundoscopy) categorized as probably or definitely related to test article. |
| Primary | TE-SAEs of Visual Acuity Decrease | Safety assessment period (12 months) | The proportion of 12-month safety population subjects that experience at least one visual acuity TE-SAE (defined as an increase of 0.22 or greater in logMAR score) categorized as probably or definitely related to test article. |
| Primary | TE-SAEs of Increase in Intraocular Pressure | Safety assessment period (12 months) | The proportion of 12-month safety population subjects that experience at least one intraocular pressure TE-SAE (increase from baseline of greater than or equal to 10 mmHg and intraocular pressure of greater than 25 mmHg) categorized as probably or definitely related to test article. |
| Primary | TE-SAEs of the Cornea | Safety assessment period (12 months) | The proportion of 12-month safety population subjects that experience at least one cornea-related TE-SAE (detected via slit-lamp examination) categorized as probably or definitely related to test article. |
| Primary | TE-SAEs of the Retina | Safety assessment period (12-months) | The proportion 12-month safety population subjects that experience at least one retinal TE-SAE(detected via fundoscopy) categorized as probably or definitely related to test article. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease | Safety assessment period (six weeks) | 6-week safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | TE-SAEs of Increase in Intraocular Pressure | Safety assessment period (six weeks) | 6-week safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | TE-SAEs of the Cornea | Safety assessment period (six weeks) | 6-week safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | TE-SAEs of the Retina | Safety assessment period (six weeks) | 6-week safety population | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Change From Baseline in Visual Acuity | Efficacy assessment period (12 months) | 12-month primary safety analysis population | LogMAR | LEAST_SQUARES_MEAN |
| PRIMARY | TE-SAEs of Visual Acuity Decrease | Safety assessment period (12 months) | 12-month safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | TE-SAEs of Increase in Intraocular Pressure | Safety assessment period (12 months) | 12-month safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | TE-SAEs of the Cornea | Safety assessment period (12 months) | 12-month safety population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | TE-SAEs of the Retina | Safety assessment period (12-months) | 12-month safety population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease | Reproxalap | 0 | Participants | ||
| Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease | Vehicle | 0 | Participants | ||
| TE-SAEs of Increase in Intraocular Pressure | Reproxalap | 0 | Participants | ||
| TE-SAEs of Increase in Intraocular Pressure | Vehicle | 0 | Participants | ||
| TE-SAEs of the Cornea | Reproxalap | 0 | Participants | ||
| TE-SAEs of the Cornea | Vehicle | 0 | Participants | ||
| TE-SAEs of the Retina | Reproxalap | 0 | Participants | ||
| TE-SAEs of the Retina | Vehicle | 0 | Participants | ||
| Change From Baseline in Visual Acuity | Reproxalap | -0.030 | Standard Error 0.0035 | LogMAR | |
| Change From Baseline in Visual Acuity | Vehicle | -0.016 | Standard Error 0.0046 | LogMAR |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Reproxalap | 504 | |
| Overall Study | STARTED | Vehicle | 253 | |
| Overall Study | As Treated | Reproxalap | 501 | |
| Overall Study | As Treated | Vehicle | 250 | |
| Overall Study | COMPLETED | Reproxalap | 273 | |
| Overall Study | COMPLETED | Vehicle | 161 | |
| Overall Study | NOT COMPLETED | Reproxalap | 231 | |
| Overall Study | NOT COMPLETED | Vehicle | 92 |
Source ClinicalTrials.gov
Adverse events44
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 | General disorders and administration site conditions | General disorders | Reproxalap (6-week) | 205 | 503 | 205 |
| other | General disorders and administration site conditions | General disorders | Vehicle (6-week) | 8 | 251 | 8 |
| other | General disorders and administration site conditions | General disorders | Reproxalap (12-month) | 127 | 299 | 127 |
| other | General disorders and administration site conditions | General disorders | Vehicle (12-month) | 3 | 148 | 3 |
| serious | Appendicitis | Infections and infestations | Reproxalap (6-week) | 0 | 503 | 0 |
| serious | Appendicitis | Infections and infestations | Vehicle (6-week) | 0 | 251 | 0 |
| serious | Appendicitis | Infections and infestations | Reproxalap (12-month) | 0 | 299 | 0 |
| serious | Appendicitis | Infections and infestations | Vehicle (12-month) | 1 | 148 | 1 |
| serious | COVID-19 Infection | Infections and infestations | Reproxalap (6-week) | 0 | 503 | 0 |
| serious | COVID-19 Infection | Infections and infestations | Vehicle (6-week) | 0 | 251 | 0 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Reproxalap (6-week) | 0 | 503 |
| Total, all-cause mortality | Vehicle (6-week) | 0 | 251 |
| Total, all-cause mortality | Reproxalap (12-month) | 0 | 299 |
| Total, all-cause mortality | Vehicle (12-month) | 2 | 148 |
| Total, other adverse events | Reproxalap (6-week) | 205 | 503 |
| Total, other adverse events | Vehicle (6-week) | 8 | 251 |
| Total, other adverse events | Reproxalap (12-month) | 127 | 299 |
| Total, other adverse events | Vehicle (12-month) | 3 | 148 |
| Total, serious adverse events | Reproxalap (6-week) | 0 | 503 |
| Total, serious adverse events | Vehicle (6-week) | 0 | 251 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41964731 | DERIVED |
Source PubMed
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Reproxalap vs Vehicle: TE-SAEs of the Retina | Trial comparisons |
| Reproxalap vs Vehicle: TE-SAEs of the Retina | Trial comparisons |
| Reproxalap vs Vehicle: TE-SAEs of Increase in Intraocular Pressure | Trial comparisons |
| Reproxalap vs Vehicle: TE-SAEs of Visual Acuity Decrease | Trial comparisons |
| Reproxalap vs Vehicle: TE-SAEs of Increase in Intraocular Pressure | Trial comparisons |
| Reproxalap vs Vehicle: TE-SAEs of the Cornea | Trial comparisons |
| Reproxalap vs Vehicle: Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease | Trial comparisons |
| Reproxalap vs Vehicle: TE-SAEs of the Cornea | 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/NCT04735393
GET https://conductscience.org/api/trials/v1/NCT04735393/events?page=2