Trial Outcomes & Findings for A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis (NCT NCT02406209)

Last Updated: 2023-03-27

Results Overview

Change from baseline comparison of NS2 ophthalmic drops (0.5%), NS2 (0.5%) and Pred Forte® (0.1%) ophthalmic drops, and Pred Forte® (1%) ophthalmic drops on an anterior chamber cell grade scale of 0 to 4 (0 = absent, 4 = severe). The least squares mean (standard error) was derived from analysis of covariance (ANCOVA) with baseline as a covariate and treatment group as a factor.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

The efficacy assessment period was assessed at Week 8; baseline was Day 1.

Results posted on

2023-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	NS2 Ophthalmic Drops (0.5%) NS2 administered four times daily (QID) for approximately 6 weeks	NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops NS2 QID for approximately 6 weeks and Pred Forte® twice daily (BID) tapered through Week 4	Pred Forte® (1%) Ophthalmic Drops Pred Forte® QID tapered through Week 6
Overall Study STARTED	15	16	14
Overall Study COMPLETED	7	7	6
Overall Study NOT COMPLETED	8	9	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety and Efficacy Study of NS2 in Patients With Anterior Uveitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NS2 Ophthalmic Drops (0.5%) n=15 Participants NS2 administered four times daily (QID) for approximately 6 weeks	NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops n=16 Participants NS2 QID for approximately 6 weeks and Pred Forte® twice daily (BID) tapered through Week 4	Pred Forte® (1%) Ophthalmic Drops n=14 Participants Pred Forte® QID tapered through Week 6	Total n=45 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 13.84 • n=5 Participants	48.0 years STANDARD_DEVIATION 19.49 • n=7 Participants	40.9 years STANDARD_DEVIATION 11.38 • n=5 Participants	45.4 years STANDARD_DEVIATION 15.44 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	8 Participants n=5 Participants	32 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	13 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	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 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	5 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	32 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 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
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	12 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	42 Participants n=4 Participants
Region of Enrollment United States	15 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	45 Participants n=4 Participants
Height	168.9 centimeters STANDARD_DEVIATION 14.45 • n=5 Participants	165.7 centimeters STANDARD_DEVIATION 9.38 • n=7 Participants	168.6 centimeters STANDARD_DEVIATION 10.24 • n=5 Participants	167.7 centimeters STANDARD_DEVIATION 11.39 • n=4 Participants
Weight	79.7 kilograms STANDARD_DEVIATION 18.53 • n=5 Participants	78.5 kilograms STANDARD_DEVIATION 25.04 • n=7 Participants	78.3 kilograms STANDARD_DEVIATION 22.46 • n=5 Participants	78.8 kilograms STANDARD_DEVIATION 21.74 • n=4 Participants

PRIMARY outcome

Timeframe: The efficacy assessment period was assessed at Week 8; baseline was Day 1.

Population: Modified intent-to-treat

Outcome measures

Outcome measures
Measure	NS2 Ophthalmic Drops (0.5%) n=15 Participants NS2 administered four times daily (QID) for approximately 6 weeks	NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops n=16 Participants NS2 QID for approximately 6 weeks and Pred Forte® twice daily (BID) tapered through Week 4	Pred Forte® (1%) Ophthalmic Drops n=13 Participants Pred Forte® QID tapered through Week 6
Anterior Chamber Cell Grade at Week 8	-0.7 units on a scale Standard Error 0.31	-0.9 units on a scale Standard Error 0.29	-0.5 units on a scale Standard Error 0.32

Adverse Events

NS2 Ophthalmic Drops (0.5%)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Pred Forte® (1%) Ophthalmic Drops

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Measure	NS2 Ophthalmic Drops (0.5%) n=15 participants at risk NS2 administered four times daily (QID) for approximately 6 weeks	NS2 (0.5%) and Pred Forte® (0.1%) Ophthalmic Drops n=16 participants at risk NS2 QID for approximately 6 weeks and Pred Forte® twice daily (BID) tapered through Week 4	Pred Forte® (1%) Ophthalmic Drops n=14 participants at risk Pred Forte® QID tapered through Week 6
Eye disorders Iridocyclitis	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	7.1% 1/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Eye disorders Conjunctival haemorrhage	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Eye disorders Cystoid macular oedema	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Eye disorders Eye inflammation	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Eye disorders Eye pruritus	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Eye disorders Lacrimation increased	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Eye disorders Macular oedema	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Eye disorders Ocular hyperaemia	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Nervous system disorders Headache	13.3% 2/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Nervous system disorders Dizziness	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Nervous system disorders Head discomfort	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Nervous system disorders Photophobia	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Nervous system disorders Visual acuity reduced	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Musculoskeletal and connective tissue disorders Ligament rupture	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	7.1% 1/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Musculoskeletal and connective tissue disorders Ligament sprain	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Infections and infestations Cystitis	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Infections and infestations Pneumonia	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	7.1% 1/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Injury, poisoning and procedural complications Joint injury	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Injury, poisoning and procedural complications Ligament sprain	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Cardiac disorders Syncope	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Ear and labyrinth disorders Vertigo	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Gastrointestinal disorders Mouth ulceration	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	7.1% 1/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
General disorders Asthenia	0.00% 0/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	6.2% 1/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
Skin and subcutaneous tissue disorders Rash	6.7% 1/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.
General disorders General disorders and administration site conditions	40.0% 6/15 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	25.0% 4/16 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.	0.00% 0/14 • The period of time over which adverse events were collected for each subject in the clinical trial was approximately nine weeks.