Trial Outcomes & Findings for The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease (NCT NCT05062330)

Last Updated: 2025-03-18

Results Overview

Change from baseline comparison of reproxalap to vehicle for Schirmer test (0 to 35 mm). Higher scores represent greater tear production. The least squares mean (standard error) was derived from a mixed model repeated measures analysis of change from baseline, with baseline as a covariate, and time point and treatment group as factors.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

361 participants

Primary outcome timeframe

The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.

Results posted on

2025-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Reproxalap Reproxalap ophthalmic solution (0.25%) was administered 7 times over two consecutive days.	Vehicle Vehicle ophthalmic solution was administered 7 times over two consecutive days.
Overall Study STARTED	181	180
Overall Study COMPLETED	168	168
Overall Study NOT COMPLETED	13	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The TRANQUILITY 2 Trial: A Phase 3 Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reproxalap n=181 Participants Reproxalap ophthalmic solution (0.25%) was administered 7 times over two consecutive days.	Vehicle n=180 Participants Vehicle ophthalmic solution was administered 7 times over two consecutive days.	Total n=361 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	83 Participants n=5 Participants	98 Participants n=7 Participants	181 Participants n=5 Participants
Age, Categorical >=65 years	98 Participants n=5 Participants	82 Participants n=7 Participants	180 Participants n=5 Participants
Age, Continuous	64.2 years STANDARD_DEVIATION 12.2 • n=5 Participants	61.9 years STANDARD_DEVIATION 12.9 • n=7 Participants	63.1 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	126 Participants n=7 Participants	249 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	54 Participants n=7 Participants	112 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	3 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	171 Participants n=5 Participants	177 Participants n=7 Participants	348 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 (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 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
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	36 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) White	147 Participants n=5 Participants	132 Participants n=7 Participants	279 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.

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

Outcome measures

Outcome measures
Measure	Vehicle n=180 Participants Vehicle ophthalmic solution was administered 7 times over two consecutive days.	Reproxalap n=181 Participants Reproxalap ophthalmic solution (0.25%) was administered 7 times over two consecutive days.
Schirmer Test Mean Change From Baseline	-0.5 length in millimeters Standard Error 0.4	1.8 length in millimeters Standard Error 0.4

PRIMARY outcome

Timeframe: The efficacy assessment period was before and after the final dose on Day 1 (Dose 4). Baseline was approximately two weeks before dosing at Screening.

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

Comparison of reproxalap to vehicle for number of subject eyes that are Schirmer test responders (10 millimeters or more increase from baseline). A generalized estimating equation analysis was performed with baseline as a covariate, and time point and treatment group as factors.

Outcome measures

Outcome measures
Measure	Vehicle n=180 Participants Vehicle ophthalmic solution was administered 7 times over two consecutive days.	Reproxalap n=181 Participants Reproxalap ophthalmic solution (0.25%) was administered 7 times over two consecutive days.
Number of Subject Eyes That Are Schirmer Test Responders	54 eyes	116 eyes

Adverse Events

Reproxalap

Serious events: 0 serious events

Other events: 145 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Reproxalap n=181 participants at risk Reproxalap ophthalmic solution (0.25%) was administered 7 times over two consecutive days.	Vehicle n=180 participants at risk Vehicle ophthalmic solution was administered 7 times over two consecutive days.
General disorders General disorders and administration site conditions	80.1% 145/181 • Number of events 145 • The safety assessment period was two days.	3.3% 6/180 • Number of events 6 • The safety assessment period was two days.

Additional Information

Director of Clinical Trials

Aldeyra Therapeutics, Inc.

Phone: 781-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place