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

Dry Eye Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735393
• Other study ID #: ADX-102-DED-021
• Status: Completed
• Phase: Phase 3
• Start date: January 26, 2021
• Est. completion date: October 11, 2022

Study information

• Verified date: February 2022
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: October 11, 2022
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).
• Placebo Comparator
Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).
• Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).
• Placebo Comparator
Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular treatment emergent adverse events (TEAEs)	Percentages of subjects with ocular treatment-emergent adverse events (TEAEs).	Safety assessment period (Day 1 through Day 28 or Day 1 through Day 360)