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

Dry Eye Syndromes Clinical Trial

Official title:

A Single-Center, Phase 2a, Randomized, Double Masked, Clinical Study to Assess the Safety, Tolerability, and Pharmacodynamic Activity of ADX-102 Ophthalmic Solution in Subjects With Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162783
• Other study ID #: ADX-102-DES-007
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2017
• Est. completion date: July 6, 2017

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 6, 2017
• Est. primary completion date: July 6, 2017
• 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 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;

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.
• ADX-102 Ophthalmic Solution (0.1%)
ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.
• ADX-102 Ophthalmic Lipid Solution (0.5%)
ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.

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