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Completed

NCT Number: 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

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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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age (either gender and any race);
  • Reported history of dry eye for at least 6 months prior to Visit 1;
  • History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.

Exclusion criteria

  • Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
  • Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
  • Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
  • Eye drop use within 2 hours of Visit 1;
  • Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
  • Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
  • Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
  • Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.

Treatment and study plan

Reproxalap ophthalmic solution (0.25%)

Drug

Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).

placebo comparator

Drug

Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).

Primary outcomes

  1. Treatment-Emergent Serious Adverse Events (TE-SAEs) of Visual Acuity Decrease

    Time frame: 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.

  2. TE-SAEs of Increase in Intraocular Pressure

    Time frame: 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.

  3. TE-SAEs of the Cornea

    Time frame: 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.

  4. TE-SAEs of the Retina

    Time frame: 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.

  5. TE-SAEs of Visual Acuity Decrease

    Time frame: 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.

  6. TE-SAEs of Increase in Intraocular Pressure

    Time frame: 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.

  7. TE-SAEs of the Cornea

    Time frame: 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.

  8. TE-SAEs of the Retina

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 3, 2021
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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