Trial · NCT03494504
ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
NCT03494504, Phase 3, Completed, Aldeyra Therapeutics, Inc.; results first posted 2025-02-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis. Trials, record NCT03494504. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03494504
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis
- NCT number
- NCT03494504
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 318 participants, actual
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Conditions
- Allergic Conjunctivitis
- Interventions
- Reproxalap Ophthalmic Solution (0.25%), Reproxalap Ophthalmic Solution (0.5%), Vehicle Ophthalmic Solution
- First posted
- 2018-04-11
- Last updated
- 2025-02-11
- Results first posted
- 2025-02-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Subject-reported Ocular Itching Score | Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing. | Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better. |
| Secondary | Number of Subjects With Two-point Reduction in Itching Score | Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing. | The number of within subject 2-point responders (2-point reduction in itch score from 20-60 minutes post-challenge) using a 0 to 4 scale (0 = least, 4 = most) from the 5-minute post-challenge itch score at baseline was assessed. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Subject-reported Ocular Itching Score | Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing. | Intent-to-treat population with observed data only | units on a scale*minutes | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Subjects With Two-point Reduction in Itching Score | Efficacy was assessed after a single dose; baseline was assessed approximately two weeks before dosing. | Intent-to-treat population with observed data only | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Subject-reported Ocular Itching Score | Reproxalap Ophthalmic Solution (0.25%) | 52.003 | Standard Error 3.3053 | units on a scale*minutes | |
| Subject-reported Ocular Itching Score | Reproxalap Ophthalmic Solution (0.5%) | 60.040 | Standard Error 3.4552 | units on a scale*minutes | |
| Subject-reported Ocular Itching Score | Vehicle Ophthalmic Solution | 74.657 | Standard Error 3.3076 | units on a scale*minutes | |
| Number of Subjects With Two-point Reduction in Itching Score | Reproxalap Ophthalmic Solution (0.25%) | 88 | Participants | ||
| Number of Subjects With Two-point Reduction in Itching Score | Reproxalap Ophthalmic Solution (0.5%) | 77 | Participants | ||
| Number of Subjects With Two-point Reduction in Itching Score | Vehicle Ophthalmic Solution | 77 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Reproxalap Ophthalmic Solution (0.25%) | 109 | |
| Overall Study | STARTED | Reproxalap Ophthalmic Solution (0.5%) | 100 | |
| Overall Study | STARTED | Vehicle Ophthalmic Solution | 109 | |
| Overall Study | COMPLETED | Reproxalap Ophthalmic Solution (0.25%) | 109 | |
| Overall Study | COMPLETED | Reproxalap Ophthalmic Solution (0.5%) | 100 | |
| Overall Study | COMPLETED | Vehicle Ophthalmic Solution | 109 | |
| Overall Study | NOT COMPLETED | Reproxalap Ophthalmic Solution (0.25%) | 0 | |
| Overall Study | NOT COMPLETED | Reproxalap Ophthalmic Solution (0.5%) | 0 | |
| Overall Study | NOT COMPLETED | Vehicle Ophthalmic Solution | 0 |
Source ClinicalTrials.gov
Adverse events3
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 Ophthalmic Solution (0.25%) | 31 | 109 | |
| other | General disorders and administration site conditions | General disorders | Reproxalap Ophthalmic Solution (0.5%) | 41 | 100 | |
| other | General disorders and administration site conditions | General disorders | Vehicle Ophthalmic Solution | 1 | 109 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Reproxalap Ophthalmic Solution (0.25%) | 0 | 109 |
| Total, all-cause mortality | Reproxalap Ophthalmic Solution (0.5%) | 0 | 100 |
| Total, all-cause mortality | Vehicle Ophthalmic Solution | 0 | 109 |
| Total, other adverse events | Reproxalap Ophthalmic Solution (0.25%) | 31 | 109 |
| Total, other adverse events | Reproxalap Ophthalmic Solution (0.5%) | 41 | 100 |
| Total, other adverse events | Vehicle Ophthalmic Solution | 1 | 109 |
| Total, serious adverse events | Reproxalap Ophthalmic Solution (0.25%) | 0 | 109 |
| Total, serious adverse events | Reproxalap Ophthalmic Solution (0.5%) | 0 | 100 |
| Total, serious adverse events | Vehicle Ophthalmic Solution | 0 | 109 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03494504
GET https://conductscience.org/api/trials/v1/NCT03494504/registered