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A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reproxalap (0.25%) for six weeks | Experimental | Reproxalap four times daily (QID) for four weeks followed by two times daily (BID) for two weeks |
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| Vehicle for six weeks | Placebo Comparator | Vehicle QID for four weeks followed by BID for two weeks |
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| Reproxalap (0.25%) for 12 months | Experimental | Reproxalap (0.25%) QID for four weeks followed by BID for 11 months |
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| Vehicle for 12 months | Placebo Comparator | Vehicle QID for four weeks followed by BID for 11 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | Drug | Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks). |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease | 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. | Safety assessment period (six weeks) |
| TE-SAEs of Increase in Intraocular Pressure | 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. | Safety assessment period (six weeks) |
| TE-SAEs of the Cornea | 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. | Safety assessment period (six weeks) |
| TE-SAEs of the Retina | 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. | Safety assessment period (six weeks) |
| TE-SAEs of Visual Acuity Decrease | 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. | Safety assessment period (12 months) |
| TE-SAEs of Increase in Intraocular Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41964731 | Derived | Radcliffe NM, Sheppard J, Simmons B, Owen D, Nguyen A, Cavanagh B, Brady TC. Phase 3 Randomized Clinical Trial Evaluating the Safety of Reproxalap in Patients With Dry Eye Disease. Ophthalmol Ther. 2026 May;15(5):1807-1821. doi: 10.1007/s40123-026-01379-0. Epub 2026 Apr 11. |
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The 6-week safety population are subjects randomized and treated in either the 6-week or 12-month cohort. The 12-month safety population are subjects randomized and treated in the 12-month cohort. There was a total of 757 randomized subjects in the trial. There were 6 subjects randomized and not dosed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reproxalap | Reproxalap was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months. |
| FG001 | Vehicle | Vehicle was administered four times daily for four weeks followed by two times daily for either two weeks or 11 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2022 |
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| Placebo Comparator | Drug | Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks). |
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| Reproxalap Ophthalmic Solution (0.25%) | Drug | Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months). |
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| Placebo Comparator | Drug | Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months). |
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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. |
| Safety assessment period (12 months) |
| TE-SAEs of the Cornea | 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. | Safety assessment period (12 months) |
| TE-SAEs of the Retina | 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. | Safety assessment period (12-months) |
| As Treated |
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| COMPLETED |
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| NOT COMPLETED |
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6-week safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | Reproxalap (6-week) | Reproxalap was administered four times daily for four weeks followed by two times daily for two weeks. |
| BG001 | Vehicle (6-week) | Vehicle was administered four times daily for four weeks followed by two times daily for two weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease | 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. | 6-week safety population | Posted | Count of Participants | Participants | Safety assessment period (six weeks) |
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| Primary | TE-SAEs of Increase in Intraocular Pressure | 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. | 6-week safety population | Posted | Count of Participants | Participants | Safety assessment period (six weeks) |
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| Primary | TE-SAEs of the Cornea | 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. | 6-week safety population | Posted | Count of Participants | Participants | Safety assessment period (six weeks) |
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| Primary | TE-SAEs of the Retina | 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. | 6-week safety population | Posted | Count of Participants | Participants | Safety assessment period (six weeks) |
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| Post-Hoc | Change From Baseline in Visual Acuity | Overall change from baseline in visual acuity logMAR score. Visual acuity values were averaged across both eyes for each participant. | 12-month primary safety analysis population | Posted | Least Squares Mean | Standard Error | LogMAR | Efficacy assessment period (12 months) | eyes | eyes |
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| Primary | TE-SAEs of Visual Acuity Decrease | 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. | 12-month safety population | Posted | Count of Participants | Participants | Safety assessment period (12 months) |
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| Primary | TE-SAEs of Increase in Intraocular Pressure | 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. | 12-month safety population | Posted | Count of Participants | Participants | Safety assessment period (12 months) |
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| Primary | TE-SAEs of the Cornea | 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. | 12-month safety population | Posted | Count of Participants | Participants | Safety assessment period (12 months) |
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| Primary | TE-SAEs of the Retina | 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. | 12-month safety population | Posted | Count of Participants | Participants | Safety assessment period (12-months) |
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Safety assessment period (6 weeks or 12 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Reproxalap (6-week) | Reproxalap was administered four times daily for four weeks followed by two times daily for two weeks. | 0 | 503 | 0 | 503 | 205 | 503 |
| EG001 | Vehicle (6-week) | Vehicle was administered four times daily for four weeks followed by two times daily for two weeks. | 0 | 251 | 0 | 251 | 8 | 251 |
| EG002 | Reproxalap (12-month) | Reproxalap was administered four times daily for four weeks followed by two times daily for 11 months. | 0 | 299 | 3 | 299 | 127 | 299 |
| EG003 | Vehicle (12-month) | Vehicle was administered four times daily for four weeks followed by two times daily for 11 months. | 2 | 148 | 5 | 148 | 3 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | Systematic Assessment | The SAE was deemed not related to study drug. |
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| COVID-19 Infection | Infections and infestations | Systematic Assessment | The SAE was deemed not related to study drug. |
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| Unknown cause of death | General disorders | Systematic Assessment | The SAE was deemed not related to study drug. |
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| Premature ventricular contractions | Cardiac disorders | Systematic Assessment | The SAE was deemed not related to study drug. |
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| Unstable Angina | Cardiac disorders | Systematic Assessment | The SAE was deemed not related to study drug. |
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| Worsening coronary artery disease | Cardiac disorders | Systematic Assessment |
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| Right tonsil squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | The SAE was deemed not related to study drug. |
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| Worsening of chronic back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | The SAE was deemed not related to study drug. |
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| Kidney infection | Infections and infestations | Systematic Assessment | The SAE was deemed not related to study drug. |
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| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment | The SAE was deemed not related to study drug. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
| Jun 24, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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| Multiple |
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| eyes |
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