NCT04735393Phase 3Completed

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

Study sponsor: Aldeyra Therapeutics, Inc. · ALDX

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2022-10-11Actual

Enrollment · participants757Actual

Source updated2025-11-26Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-11-14 · 1 field changed

Enrollment · participant count

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Posted 2025-10-30 · 2 fields changed

Primary outcomes · main study measures

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measure: Ocular treatment emergent adverse events (TEAEs)

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measure: Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease; measure: TE-SAEs of Increase in Intraocular Pressure; measure: TE-SAEs of the Cornea; measure: TE-SAEs of the Retina; measure: TE-SAEs of Visual Acuity Decrease; measure: TE-SAEs of Increase in Intraocular Pressure; measure: TE-SAEs of the Cornea; measure: TE-SAEs of the Retina

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Enrollment · participant count

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+ Updated value

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Study details

Conditions studied

Dry Eye Disease

Treatments or interventions studied

Reproxalap Ophthalmic Solution (0.25%)Drug
Placebo ComparatorDrug
Reproxalap Ophthalmic Solution (0.25%)Drug
Placebo ComparatorDrug

Primary outcomes · main study measures

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measure: Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease; description: 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.; timeFrame: Safety assessment period (six weeks); measure: TE-SAEs of Increase in Intraocular Pressure; description: 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.; timeFrame: Safety assessment period (six weeks); measure: TE-SAEs of the Cornea; description: 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.; timeFrame: Safety assessment period (six weeks); measure: TE-SAEs of the Retina; description: 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.; timeFrame: Safety assessment period (six weeks); measure: TE-SAEs of Visual Acuity Decrease; description: 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.; timeFrame: Safety assessment period (12 months); measure: TE-SAEs of Increase in Intraocular Pressure; description: 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.; timeFrame: Safety assessment period (12 months); measure: TE-SAEs of the Cornea; description: 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.; timeFrame: Safety assessment period (12 months); measure: TE-SAEs of the Retina; description: 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.; timeFrame: Safety assessment period (12-months)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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