A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome

Phase 2

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: ADX-102 Ophthalmic Solution (0.5%); Drug: ADX-102 Ophthalmic Solution (0.1%); Drug: ADX-102 Ophthalmic Lipid Solution (0.5%)

• Registration Number: NCT03162783
• Lead Sponsor: Aldeyra Therapeutics, Inc.

Brief Summary

The objective of this study is to evaluate the safety, tolerability, and pharmacodynamic activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects with dry eye syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-15
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Primary Completion: 2017-07-06
• Study Completion: 2017-07-06
• Status Verified: 2018-06
• Disposition First Submitted: 2018-06-29
• Disposition First Submitted QC: 2018-06-29
• Last Update Submitted: 2018-06-29
• Disposition First Posted: 2018-07-05
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 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 45 days of Visit 1;
• Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within the last 6 months;
• 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
ADX-102 Ophthalmic Solution (0.5%)	ADX-102 Ophthalmic Solution (0.5%)	-
ADX-102 Ophthalmic Solution (0.1%)	ADX-102 Ophthalmic Solution (0.1%)	-
ADX-102 Ophthalmic Lipid Solution (0.5%)	ADX-102 Ophthalmic Lipid Solution (0.5%)	-

Primary Outcome Measures

Name	Time	Method
Assess safety and tolerability of ADX-102 formulations using adverse event query.	Safety Assessment Period (Day 1 through Day 29)	Evaluate the safety and tolerability of ADX-102 formulations in subjects with dry eye syndrome.

Secondary Outcome Measures

Name	Time	Method
Efficacy of ADX-102 on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.	Efficacy assessment period (Day 1 through Day 29)	Evaluate the symptoms of ADX-102 on ocular discomfort in subjects with dry eye syndrome.
Efficacy of ADX-102 on dry eye syndrome symptoms using the Symptom Assessment in Dry Eye (SANDE) scale.	Efficacy assessment period (Day 1 through Day 29)	Evaluate the dry eye symptoms of ADX-102 in subjects with dry eye syndrome.
Efficacy of ADX-102 on dry eye syndrome using the Ocular Surface and Disease Index (OSDI) © questionnaire.	Efficacy assessment period (Day 1 through Day 29)	Evaluate the symptoms of ADX-102 in subjects with dry eye syndrome.
Efficacy of ADX-102 on fluorescein staining using the Ora Calibra® scale.	Efficacy assessment period (Day 1 through Day 29)	Evaluate fluorescein staining of ADX-102 in subjects with dry eye syndrome.
Efficacy of ADX-102 on tear film break-up time (TFBUT©).	Efficacy assessment period (Day 1 through Day 29)	Evaluate tear film break-up time of ADX-102 in subjects with dry eye syndrome.

Trial Locations

Locations (1)

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