Trial Outcomes & Findings for The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease (NCT NCT04674358)
NCT ID: NCT04674358
Last Updated: 2025-03-19
Results Overview
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.
COMPLETED
PHASE2/PHASE3
329 participants
The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.
2025-03-19
Participant Flow
There were 331 randomized subjects, of which 329 were unique (23 in the initial exploratory cohort and 306 in the main cohort). Two subjects in the main cohort were randomized twice by accident and two subjects were randomized but not dosed, making the safety population 327 subjects. The Safety population is presented in the Participant Flow, Baseline Characteristics, and Adverse Events. Efficacy analysis was conducted on subjects in the main cohort (306 subjects, intent-to-treat population).
Participant milestones
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
Subjects randomized to reproxalap ophthalmic solution administered seven times over two consecutive days
|
Vehicle
Subjects randomized to vehicle ophthalmic solution administered seven times over two consecutive days
|
|---|---|---|
|
Overall Study
STARTED
|
164
|
163
|
|
Overall Study
COMPLETED
|
162
|
160
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=164 Participants
Reproxalap ophthalmic solution administered seven times over two consecutive days
|
Vehicle
n=163 Participants
Vehicle ophthalmic solution administered seven times over two consecutive days
|
Total
n=327 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
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
77 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
305 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
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
18 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
132 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
164 participants
n=5 Participants
|
163 participants
n=7 Participants
|
327 participants
n=5 Participants
|
|
Iris Color (Right Eye)
Black
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Blue
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Brown
|
75 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Hazel
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Green
|
14 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Gray
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Iris Color (Right Eye)
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Black
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Blue
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Brown
|
75 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Hazel
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Green
|
14 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Gray
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Iris Color (Left Eye)
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.Population: Intent-to-treat population with observed data only
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = normal, 4 = prominent), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.
Outcome measures
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=153 Participants
Reproxalap ophthalmic solution administered six times over two consecutive days
|
Vehicle
n=153 Participants
Vehicle ophthalmic solution administered six times over two consecutive days
|
|---|---|---|
|
Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber
|
0.185 units on a scale
Standard Error 0.0233
|
0.156 units on a scale
Standard Error 0.0229
|
SECONDARY outcome
Timeframe: The efficacy assessment period was before and after the final dose on Day 1; baseline was Pre-Dose #1 at Day 1.Population: Intent-to-treat population with observed data only
Change from baseline comparison of reproxalap to vehicle for Schirmer test on a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline and treatment group as fixed effects.
Outcome measures
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=153 Participants
Reproxalap ophthalmic solution administered six times over two consecutive days
|
Vehicle
n=153 Participants
Vehicle ophthalmic solution administered six times over two consecutive days
|
|---|---|---|
|
Schirmer Test Change From Baseline After the First Dose on Day 1
|
5.9 millimeters
Standard Error 0.53
|
3.5 millimeters
Standard Error 0.53
|
POST_HOC outcome
Timeframe: The efficacy assessment period was assessed during the 90-minute dry eye chamber at Day 2; baseline was Pre-Dose #1 at Day 1.Population: Intent-to-treat population with observed data only
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 255 scale ( 0 = none, 255 = maximum), where a high score means a worse outcome. The intervention was administered bilaterally. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included baseline, site, treatment group, and nominal time point as fixed effects.
Outcome measures
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=153 Participants
Reproxalap ophthalmic solution administered six times over two consecutive days
|
Vehicle
n=153 Participants
Vehicle ophthalmic solution administered six times over two consecutive days
|
|---|---|---|
|
Conjunctival Redness Assessed Over 90 Minutes in the Dry Eye Chamber Using Computer Automated Grading
|
0.309 units on a scale
Standard Error 0.2160
|
0.962 units on a scale
Standard Error 0.2121
|
POST_HOC outcome
Timeframe: Efficacy was assessed after a single dose on Day 1; baseline was assessed approximately two weeks before dosing.Population: Intent-to-treat population with observed data only
The number of subject eyes that are schirmer test responders (eyes with 10 millimeters or more increase from baseline) using a millimeter line (0 = none, 35 = maximum), where a shorter length indicates a worse outcome.
Outcome measures
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=306 eyes
Reproxalap ophthalmic solution administered six times over two consecutive days
|
Vehicle
n=306 eyes
Vehicle ophthalmic solution administered six times over two consecutive days
|
|---|---|---|
|
Number of Subject Eyes That Are Schirmer Test Responders (Eyes 10 Millimeters or More Increase From Baseline)
|
125 eyes
|
64 eyes
|
Adverse Events
Reproxalap Ophthalmic Solution (0.25%)
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Reproxalap Ophthalmic Solution (0.25%)
n=164 participants at risk
Reproxalap ophthalmic solution administered seven times over two consecutive days
|
Vehicle
n=163 participants at risk
Vehicle ophthalmic solution administered seven times over two consecutive days
|
|---|---|---|
|
General disorders
General disorders and administration site conditions
|
72.0%
118/164 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately one week.
|
1.2%
2/163 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately one week.
|
Additional Information
Sr. Director, Clinical Operations
Aldeyra Therapeutics, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place