Trial · NCT03131154

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

NCT03131154, Phase 3, Completed, Aldeyra Therapeutics, Inc.; results first posted 2025-02-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis. Trials, record NCT03131154. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03131154

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: SOLACE Trial - A Phase 3 Trial in Subjects With Non-infectious Anterior-uveitis.
NCT number: NCT03131154
Status: Completed
Phases: Phase 3
Enrollment: 123 participants, actual
Lead sponsor: Aldeyra Therapeutics, Inc.
Conditions: Non-infectious Anterior Uveitis
Interventions: ADX-102 Ophthalmic Solution (0.5%), Vehicle of ADX-102 Ophthalmic Solution
First posted: 2017-04-27
Last updated: 2025-02-10
Results first posted: 2025-02-10

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells	The efficacy assessment period was 4 weeks; baseline was defined as Day 1.	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).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells	The efficacy assessment period was 4 weeks; baseline was defined as Day 1.	Intent-to-treat population	Subjects	NUMBER
POST_HOC	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	The efficacy assessment period was 4 weeks; baseline was defined as Day 1.	Intent-to-treat population in grade 1+ or grade 2+ subjects with a baseline anterior chamber cell count \> 10	Subjects	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells	ADX-102 Ophthalmic Solution (0.5%)	25	Subjects
Number of Subjects Who Meet Time to Clearance of Anterior Chamber Cells	Vehicle Ophthalmic Solution	24	Subjects
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	ADX-102 Ophthalmic Solution (0.5%)	13	Subjects
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	Vehicle Ophthalmic Solution	6	Subjects

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ADX-102 Ophthalmic Solution (0.5%)	61
Overall Study	STARTED	Vehicle Ophthalmic Solution	62
Overall Study	COMPLETED	ADX-102 Ophthalmic Solution (0.5%)	37
Overall Study	COMPLETED	Vehicle Ophthalmic Solution	33
Overall Study	NOT COMPLETED	ADX-102 Ophthalmic Solution (0.5%)	24
Overall Study	NOT COMPLETED	Vehicle Ophthalmic Solution	29

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Uveitis	Eye disorders	ADX-102 Ophthalmic Solution (0.5%)	7	61
other	Uveitis	Eye disorders	Vehicle Ophthalmic Solution	7	62
other	Eye pain	Eye disorders	ADX-102 Ophthalmic Solution (0.5%)	7	61
other	Eye pain	Eye disorders	Vehicle Ophthalmic Solution	7	62
other	Visual acuity reduced	Eye disorders	ADX-102 Ophthalmic Solution (0.5%)	3	61
other	Visual acuity reduced	Eye disorders	Vehicle Ophthalmic Solution	6	62
other	Iridocyclitis	Eye disorders	ADX-102 Ophthalmic Solution (0.5%)	4	61
other	Iridocyclitis	Eye disorders	Vehicle Ophthalmic Solution	3	62
other	Eye inflammation	Eye disorders	ADX-102 Ophthalmic Solution (0.5%)	2	61
other	Eye inflammation	Eye disorders	Vehicle Ophthalmic Solution	4	62

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	ADX-102 Ophthalmic Solution (0.5%)	0	61
Total, all-cause mortality	Vehicle Ophthalmic Solution	0	62
Total, other adverse events	ADX-102 Ophthalmic Solution (0.5%)	36	61
Total, other adverse events	Vehicle Ophthalmic Solution	31	62
Total, serious adverse events	ADX-102 Ophthalmic Solution (0.5%)	1	61
Total, serious adverse events	Vehicle Ophthalmic Solution	2	62

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
ADX-102 Ophthalmic Solution (0.5%) vs Vehicle Ophthalmic Solution: deaths from any cause	Trial comparisons
ADX-102 Ophthalmic Solution (0.5%) vs Vehicle Ophthalmic Solution: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03131154

GET https://conductscience.org/api/trials/v1/NCT03131154/registered

API reference For AI assistants