Trial Outcomes & Findings for SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis. (NCT NCT03131154)

Last Updated: 2025-02-10

Results Overview

Time to clearance of anterior chamber cells was defined as the time from initiation of study drug to when a cell count of 0 was achieved and maintained (without cell count increases to \>0) to Week 4 and without rescue or discontinuation due to rescue prior to Week 4. Anterior chamber cell count is the number of cells visible within the anterior chamber of the eye, measured using a slit lamp and following SUN (Standardization of Uveitis Nomenclature) where a cell count \<1 is Grade 0 (absent) and a cell count of \>50 is Grade 4+ (severe).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

123 participants

Primary outcome timeframe

The efficacy assessment period was 4 weeks; baseline was defined as Day 1.

Results posted on

2025-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	ADX-102 Ophthalmic Solution (0.5%) ADX-102 administered for approximately 4 weeks	Vehicle Ophthalmic Solution Vehicle administered for approximately 4 weeks
Overall Study STARTED	61	62
Overall Study COMPLETED	37	33
Overall Study NOT COMPLETED	24	29

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADX-102 Ophthalmic Solution (0.5%) n=61 Participants ADX-102 administered for approximately 4 weeks	Vehicle Ophthalmic Solution n=62 Participants Vehicle administered for approximately 4 weeks	Total n=123 Participants Total of all reporting groups
Age, Continuous	45.3 years STANDARD_DEVIATION 15.8 • n=5 Participants	47.8 years STANDARD_DEVIATION 17.9 • n=7 Participants	46.5 years STANDARD_DEVIATION 16.9 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	41 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	21 Participants n=7 Participants	48 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	40 Participants n=7 Participants	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	50 Participants n=5 Participants	48 Participants n=7 Participants	98 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants	62 participants n=7 Participants	123 participants n=5 Participants
Height	167.09 centimeters STANDARD_DEVIATION 9.72 • n=5 Participants	169.30 centimeters STANDARD_DEVIATION 9.57 • n=7 Participants	168.2 centimeters STANDARD_DEVIATION 9.67 • n=5 Participants
Weight	85.95 kilograms STANDARD_DEVIATION 20.62 • n=5 Participants	85.45 kilograms STANDARD_DEVIATION 21.98 • n=7 Participants	85.70 kilograms STANDARD_DEVIATION 21.23 • n=5 Participants
Subjects with Bilateral Uveitis Right Eye	25 participants n=5 Participants	23 participants n=7 Participants	48 participants n=5 Participants
Subjects with Bilateral Uveitis Left Eye	30 participants n=5 Participants	34 participants n=7 Participants	64 participants n=5 Participants
Subjects with Bilateral Uveitis Both Eyes	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: The efficacy assessment period was 4 weeks; baseline was defined as Day 1.

Population: Intent-to-treat population

Outcome measures

Outcome measures
Measure	ADX-102 Ophthalmic Solution (0.5%) n=61 Participants ADX-102 administered for approximately 4 weeks	Vehicle Ophthalmic Solution n=62 Participants Vehicle administered for approximately 4 weeks
Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells	25 Subjects	24 Subjects

POST_HOC outcome

Timeframe: The efficacy assessment period was 4 weeks; baseline was defined as Day 1.

Population: Intent-to-treat population in grade 1+ or grade 2+ subjects with a baseline anterior chamber cell count \> 10

Outcome measures

Outcome measures
Measure	ADX-102 Ophthalmic Solution (0.5%) n=26 Participants ADX-102 administered for approximately 4 weeks	Vehicle Ophthalmic Solution n=26 Participants Vehicle administered for approximately 4 weeks
Number of Subjects With Time to Clearance of Anterior Chamber Cells in Grade 1+ or Grade 2+ Subjects With a Baseline Anterior Chamber Cell Count > 10	13 Subjects	6 Subjects

Adverse Events

ADX-102 Ophthalmic Solution (0.5%)

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Vehicle Ophthalmic Solution

Serious events: 2 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ADX-102 Ophthalmic Solution (0.5%) n=61 participants at risk ADX-102 administered for approximately 4 weeks	Vehicle Ophthalmic Solution n=62 participants at risk Vehicle administered for approximately 4 weeks
Eye disorders Visual acuity reduced	0.00% 0/61 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	1.6% 1/62 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Psychiatric disorders Suicide Attempt	1.6% 1/61 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/62 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Nervous system disorders Syncope	0.00% 0/61 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	1.6% 1/62 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.

Other adverse events

Other adverse events
Measure	ADX-102 Ophthalmic Solution (0.5%) n=61 participants at risk ADX-102 administered for approximately 4 weeks	Vehicle Ophthalmic Solution n=62 participants at risk Vehicle administered for approximately 4 weeks
Eye disorders Uveitis	11.5% 7/61 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	11.3% 7/62 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Eye pain	11.5% 7/61 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	11.3% 7/62 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Visual acuity reduced	4.9% 3/61 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	9.7% 6/62 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Iridocyclitis	6.6% 4/61 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	4.8% 3/62 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Eye inflammation	3.3% 2/61 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	6.5% 4/62 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
Eye disorders Vitreous floaters	0.00% 0/61 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	6.5% 4/62 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.
General disorders General Disorders and Administration Site Conditions	21.3% 13/61 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five weeks.	0.00% 0/62 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately five 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