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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03404115
• Other study ID #: ADX-102-DED-009
• Status: Completed
• Phase: Phase 2
• Start date: January 2, 2018
• Est. completion date: July 11, 2018

Study information

• Verified date: January 2018
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 11, 2018
• Est. primary completion date: July 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

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;

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Reproxalap Ophthalmic Solution (0.25%)
Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
• Reproxalap Ophthalmic Solution (0.1%)
Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
• Vehicle Ophthalmic Solution
Vehicle Ophthalmic Solution administered for approximately twelve weeks.

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Midwest Cornea Associates	Indianapolis	Indiana
United States	Central Maine Eye Care	Lewiston	Maine
United States	Total Eye Care	Memphis	Tennessee
United States	Andover Eye Associates	Raynham	Massachusetts
United States	The Eye Care Group	Waterbury	Connecticut

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	Assess safety and tolerability of reproxalap formulations using adverse event query.	Evaluate the safety and tolerability of reproxalap formulations in subjects with dry eye syndrome.	Safety Assessment Period (Day -14 to Day 85)
Secondary	Efficacy of reproxalap on Lissamine green staining using the Ora Calibra® scale.	Evaluate lissamine green staining of reproxalap in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 85)
Secondary	Efficacy of reproxalap on fluorescein staining using the Ora Calibra® scale.	Evaluate fluorescein staining of reproxalap in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 85)
Secondary	Efficacy of reproxalap on tear film break-up time (TFBUT©).	Evaluate tear film break-up time of reproxalap in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 85)
Secondary	Efficacy of reproxalap on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.	Evaluate the symptoms of reproxalap on ocular discomfort in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 85)
Secondary	Efficacy of reproxalap on dry eye syndrome using the Ocular Surface and Disease Index (OSDI) © questionnaire.	Evaluate the symptoms of reproxalp in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 85)
Secondary	Efficacy of reproxalap on dry eye syndrome symptoms using the Symptom Assessment in Dry Eye (SANDE) scale.	Evaluate the dry eye symptoms of reproxalap in subjects with dry eye syndrome.	Efficacy assessment period (Day 1 through Day 85)