A Multi-Center, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease

Phase 2

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Reproxalap Ophthalmic Solution (0.25%); Drug: Vehicle Ophthalmic Solution; Drug: Reproxalap Ophthalmic Solution (0.1%)

• Registration Number: NCT03404115
• Lead Sponsor: Aldeyra Therapeutics, Inc.

Brief Summary

A Multi-Center, Phase 2b, Randomized, Double Masked, Parallel-Group, Vehicle-Controlled, Clinical Study to Assess the Safety and Efficacy of Reproxalap Ophthalmic Solution (0.25% and 0.1%) Compared to Vehicle in Subjects with Dry Eye Disease

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-02
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-12
• Study First Posted: 2018-01-19
• Primary Completion: 2018-07-11
• Study Completion: 2018-07-11
• Disposition First Submitted: 2019-07-10
• Disposition First Submitted QC: 2019-07-10
• Last Update Submitted: 2019-07-10
• Disposition First Posted: 2019-07-16
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Be at least 18 years of age of either gender and any race;
• Have a reported history of dry eye for at least 6 months prior to Visit 1;
• Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1;

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Exclusion Criteria

• Have any 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;
• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
• Have used any eye drops within 2 hours of Visit 1;
• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
• Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 90 days of Visit 1;
• Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
• Be using or anticipate using temporary punctal plugs during the study that have not been stable within 30 days of Visit 1;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reproxalap Ophthalmic Solution (0.25%)	Reproxalap Ophthalmic Solution (0.25%)	-
Vehicle Ophthalmic Solution	Vehicle Ophthalmic Solution	-
Reproxalap Ophthalmic Solution (0.1%)	Reproxalap Ophthalmic Solution (0.1%)	-

Primary Outcome Measures

Name	Time	Method
Assess safety and tolerability of reproxalap formulations using adverse event query.	Safety Assessment Period (Day -14 to Day 85)	Evaluate the safety and tolerability of reproxalap formulations in subjects with dry eye syndrome.

Secondary Outcome Measures

Name	Time	Method
Efficacy of reproxalap on tear film break-up time (TFBUT©).	Efficacy assessment period (Day 1 through Day 85)	Evaluate tear film break-up time of reproxalap in subjects with dry eye syndrome.
Efficacy of reproxalap on dry eye syndrome using the Ocular Surface and Disease Index (OSDI) © questionnaire.	Efficacy assessment period (Day 1 through Day 85)	Evaluate the symptoms of reproxalp in subjects with dry eye syndrome.
Efficacy of reproxalap on Lissamine green staining using the Ora Calibra® scale.	Efficacy assessment period (Day 1 through Day 85)	Evaluate lissamine green staining of reproxalap in subjects with dry eye syndrome.
Efficacy of reproxalap on fluorescein staining using the Ora Calibra® scale.	Efficacy assessment period (Day 1 through Day 85)	Evaluate fluorescein staining of reproxalap in subjects with dry eye syndrome.
Efficacy of reproxalap on dry eye syndrome symptoms using the Symptom Assessment in Dry Eye (SANDE) scale.	Efficacy assessment period (Day 1 through Day 85)	Evaluate the dry eye symptoms of reproxalap in subjects with dry eye syndrome.
Efficacy of reproxalap on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.	Efficacy assessment period (Day 1 through Day 85)	Evaluate the symptoms of reproxalap on ocular discomfort in subjects with dry eye syndrome.

Trial Locations

Locations (5)

Midwest Cornea Associates; 🇺🇸 Indianapolis, Indiana, United States

Total Eye Care; 🇺🇸 Memphis, Tennessee, United States

Central Maine Eye Care; 🇺🇸 Lewiston, Maine, United States

The Eye Care Group; 🇺🇸 Waterbury, Connecticut, United States

Andover Eye Associates; 🇺🇸 Raynham, Massachusetts, United States