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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03162783
Enrollment
51
Registered
2017-05-22
Start date
2017-05-15
Completion date
2017-07-06
Last updated
2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Keywords

Aldeyra

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.

Interventions

DRUGADX-102 Ophthalmic Solution (0.5%)

ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.

DRUGADX-102 Ophthalmic Solution (0.1%)

ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.

DRUGADX-102 Ophthalmic Lipid Solution (0.5%)

ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.

Sponsors

Aldeyra Therapeutics, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 lifitegrast 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;

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.Efficacy assessment period (Day 1 through Day 29), Day 29 reported.Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

Countries

United States

Participant flow

Participants by arm

ArmCount
ADX-102 Ophthalmic Solution (0.5%)
ADX-102 Ophthalmic Solution (0.5%): ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.
17
ADX-102 Ophthalmic Solution (0.1%)
ADX-102 Ophthalmic Solution (0.1%): ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.
17
ADX-102 Ophthalmic Lipid Solution (0.5%)
ADX-102 Ophthalmic Lipid Solution (0.5%): ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.
17
Total51

Baseline characteristics

CharacteristicADX-102 Ophthalmic Solution (0.5%)ADX-102 Ophthalmic Solution (0.1%)ADX-102 Ophthalmic Lipid Solution (0.5%)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
10 Participants10 Participants13 Participants33 Participants
Age, Categorical
Between 18 and 65 years
7 Participants7 Participants4 Participants18 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants0 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants17 Participants17 Participants49 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Iris Color (Left Eye)
Black
0 participants0 participants0 participants0 participants
Iris Color (Left Eye)
Blue
7 participants2 participants5 participants14 participants
Iris Color (Left Eye)
Brown
6 participants13 participants6 participants25 participants
Iris Color (Left Eye)
Gray
0 participants0 participants0 participants0 participants
Iris Color (Left Eye)
Green
1 participants1 participants2 participants4 participants
Iris Color (Left Eye)
Hazel
3 participants1 participants4 participants8 participants
Iris Color (Left Eye)
Other
0 participants0 participants0 participants0 participants
Iris Color (Right Eye)
Black
0 participants0 participants0 participants0 participants
Iris Color (Right Eye)
Blue
7 participants2 participants5 participants14 participants
Iris Color (Right Eye)
Brown
6 participants13 participants6 participants25 participants
Iris Color (Right Eye)
Gray
0 participants0 participants0 participants0 participants
Iris Color (Right Eye)
Green
1 participants1 participants2 participants4 participants
Iris Color (Right Eye)
Hazel
3 participants1 participants4 participants8 participants
Iris Color (Right Eye)
Other
0 participants0 participants0 participants0 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
16 Participants15 Participants17 Participants48 Participants
Sex: Female, Male
Female
14 Participants9 Participants11 Participants34 Participants
Sex: Female, Male
Male
3 Participants8 Participants6 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 170 / 170 / 17
other
Total, other adverse events
17 / 178 / 1717 / 17
serious
Total, serious adverse events
0 / 170 / 170 / 17

Outcome results

Primary

Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.

Change from baseline of ADX-102 on ocular discomfort in subjects with dry eye disease using the Ora Calibra® Ocular Discomfort Scale (0 = least, 4 = most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

Time frame: Efficacy assessment period (Day 1 through Day 29), Day 29 reported.

Population: Intent-to-treat population with observed data only.

ArmMeasureValue (MEAN)Dispersion
ADX-102 Ophthalmic Solution (0.1%)Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.-0.81 units on a scaleStandard Deviation 0.98
ADX-102 Ophthalmic Solution (0.5%)Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.-0.75 units on a scaleStandard Deviation 0.75
ADX-102 Ophthalmic Lipid Solution (0.5%)Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.-0.82 units on a scaleStandard Deviation 1.33

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026