Trial Outcomes & Findings for A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome (NCT NCT03162783)

Last Updated: 2025-01-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

51 participants

Primary outcome timeframe

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

Results posted on

2025-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	ADX-102 Ophthalmic Solution (0.5%) 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%): ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.	ADX-102 Ophthalmic Lipid Solution (0.5%) ADX-102 Ophthalmic Lipid Solution (0.5%): ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.
Overall Study STARTED	17	17	17
Overall Study COMPLETED	12	16	11
Overall Study NOT COMPLETED	5	1	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADX-102 Ophthalmic Solution (0.5%) n=17 Participants ADX-102 Ophthalmic Solution (0.5%): ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.	ADX-102 Ophthalmic Solution (0.1%) n=17 Participants ADX-102 Ophthalmic Solution (0.1%): ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.	ADX-102 Ophthalmic Lipid Solution (0.5%) n=17 Participants ADX-102 Ophthalmic Lipid Solution (0.5%): ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	18 Participants n=4 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	34 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	17 Participants n=7 Participants	17 Participants n=5 Participants	49 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants	48 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Iris Color (Right Eye) Black	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Iris Color (Right Eye) Blue	7 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants	14 participants n=4 Participants
Iris Color (Right Eye) Brown	6 participants n=5 Participants	13 participants n=7 Participants	6 participants n=5 Participants	25 participants n=4 Participants
Iris Color (Right Eye) Hazel	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants	8 participants n=4 Participants
Iris Color (Right Eye) Green	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants
Iris Color (Right Eye) Gray	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Iris Color (Right Eye) Other	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Iris Color (Left Eye) Black	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Iris Color (Left Eye) Blue	7 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants	14 participants n=4 Participants
Iris Color (Left Eye) Brown	6 participants n=5 Participants	13 participants n=7 Participants	6 participants n=5 Participants	25 participants n=4 Participants
Iris Color (Left Eye) Hazel	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants	8 participants n=4 Participants
Iris Color (Left Eye) Green	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants
Iris Color (Left Eye) Gray	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants
Iris Color (Left Eye) Other	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants

PRIMARY outcome

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

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

Outcome measures

Outcome measures
Measure	ADX-102 Ophthalmic Solution (0.1%) n=16 Participants ADX-102 Ophthalmic Solution (0.1%): ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.	ADX-102 Ophthalmic Solution (0.5%) n=12 Participants ADX-102 Ophthalmic Solution (0.5%): ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.	ADX-102 Ophthalmic Lipid Solution (0.5%) n=11 Participants ADX-102 Ophthalmic Lipid Solution (0.5%): ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.
Efficacy of ADX-102 on Ocular Discomfort Using the Ora Calibra® Ocular Discomfort Scale.	-0.81 units on a scale Standard Deviation 0.98	-0.75 units on a scale Standard Deviation 0.75	-0.82 units on a scale Standard Deviation 1.33

Adverse Events

ADX-102 Ophthalmic Solution (0.5%)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

ADX-102 Ophthalmic Solution (0.1%)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

ADX-102 Ophthalmic Lipid Solution (0.5%)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ADX-102 Ophthalmic Solution (0.5%) n=17 participants at risk ADX-102 Ophthalmic Solution (0.5%): ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.	ADX-102 Ophthalmic Solution (0.1%) n=17 participants at risk ADX-102 Ophthalmic Solution (0.1%): ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.	ADX-102 Ophthalmic Lipid Solution (0.5%) n=17 participants at risk ADX-102 Ophthalmic Lipid Solution (0.5%): ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.
General disorders Instillation site irritation	100.0% 17/17 • Number of events 17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	47.1% 8/17 • Number of events 8 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	94.1% 16/17 • Number of events 16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.
General disorders Instillation site discomfort	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	5.9% 1/17 • Number of events 1 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.
Eye disorders Vision blurred	5.9% 1/17 • Number of events 1 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	5.9% 1/17 • Number of events 1 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.
Eye disorders Eyelid margin crusting	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	5.9% 1/17 • Number of events 1 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.
Eye disorders Ocular discomfort	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	5.9% 1/17 • Number of events 1 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.
Gastrointestinal disorders Diarrhea	5.9% 1/17 • Number of events 1 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	5.9% 1/17 • Number of events 1 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.	0.00% 0/17 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately four weeks.

Additional Information

Sr. Director, Clinical Operations

Aldeyra Therapeutics, Inc.

Phone: 781-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place