Back to resultsA Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.1%)
ADX-102 Ophthalmic Lipid Solution (0.5%)
Sponsored by
About this trial
This is an interventional other trial for Dry Eye Syndromes focused on measuring Aldeyra
Eligibility Criteria
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;
Sites / Locations
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.1%)
ADX-102 Ophthalmic Lipid Solution (0.5%)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 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 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 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 of ADX-102 on fluorescein staining using the Ora Calibra® scale.
Evaluate fluorescein staining of ADX-102 in subjects with dry eye syndrome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03162783
Brief Title
A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
July 6, 2017 (Actual)
Study Completion Date
July 6, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Aldeyra
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADX-102 Ophthalmic Solution (0.5%)
Arm Type
Experimental
Arm Title
ADX-102 Ophthalmic Solution (0.1%)
Arm Type
Experimental
Arm Title
ADX-102 Ophthalmic Lipid Solution (0.5%)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ADX-102 Ophthalmic Solution (0.5%)
Intervention Description
ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.
Intervention Type
Drug
Intervention Name(s)
ADX-102 Ophthalmic Solution (0.1%)
Intervention Description
ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.
Intervention Type
Drug
Intervention Name(s)
ADX-102 Ophthalmic Lipid Solution (0.5%)
Intervention Description
ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.
Primary Outcome Measure Information:
Title
Assess safety and tolerability of ADX-102 formulations using adverse event query.
Description
Evaluate the safety and tolerability of ADX-102 formulations in subjects with dry eye syndrome.
Time Frame
Safety Assessment Period (Day 1 through Day 29)
Secondary Outcome Measure Information:
Title
Efficacy of ADX-102 on ocular discomfort using the Ora Calibra® Ocular Discomfort scale.
Description
Evaluate the symptoms of ADX-102 on ocular discomfort in subjects with dry eye syndrome.
Time Frame
Efficacy assessment period (Day 1 through Day 29)
Title
Efficacy of ADX-102 on dry eye syndrome symptoms using the Symptom Assessment in Dry Eye (SANDE) scale.
Description
Evaluate the dry eye symptoms of ADX-102 in subjects with dry eye syndrome.
Time Frame
Efficacy assessment period (Day 1 through Day 29)
Title
Efficacy of ADX-102 on dry eye syndrome using the Ocular Surface and Disease Index (OSDI) © questionnaire.
Description
Evaluate the symptoms of ADX-102 in subjects with dry eye syndrome.
Time Frame
Efficacy assessment period (Day 1 through Day 29)
Title
Efficacy of ADX-102 on tear film break-up time (TFBUT©).
Description
Evaluate tear film break-up time of ADX-102 in subjects with dry eye syndrome.
Time Frame
Efficacy assessment period (Day 1 through Day 29)
Title
Efficacy of ADX-102 on fluorescein staining using the Ora Calibra® scale.
Description
Evaluate fluorescein staining of ADX-102 in subjects with dry eye syndrome.
Time Frame
Efficacy assessment period (Day 1 through Day 29)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33450164
Citation
Clark D, Sheppard J, Brady TC. A Randomized Double-Masked Phase 2a Trial to Evaluate Activity and Safety of Topical Ocular Reproxalap, a Novel RASP Inhibitor, in Dry Eye Disease. J Ocul Pharmacol Ther. 2021 May;37(4):193-199. doi: 10.1089/jop.2020.0087. Epub 2021 Jan 15.
Results Reference
derived
Learn more about this trial
A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome
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