Trial Outcomes & Findings for Study of Safety of RVL-1201 in Treatment of Blepharoptosis (NCT NCT03536949)

Last Updated: 2020-09-16

Results Overview

Intraocular pressure will be measured in mmHg utilizing a tonometer and using the standard of care. If possible, the same calibrated instrument should be used for a given subject throughout the study.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

234 participants

Primary outcome timeframe

Screening/Day 1 to Day 84

Results posted on

2020-09-16

Participant Flow

Planned sample size approximately 225 subjects, 150 subjects in the RVL-1201 group and 75 subjects in the Vehicle group, to be enrolled at approximately 30 clinical sites in the U.S.

Participant milestones

Participant milestones
Measure	RVL-1201 Ophthalmic Solution, 0.1% RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD for 84 days	Vehicle Ophthalmic Solution Vehicle placebo ophthalmic solution One drop each eye QD for 84 days
Overall Study STARTED	157	77
Overall Study COMPLETED	143	75
Overall Study NOT COMPLETED	14	2

Reasons for withdrawal

Reasons for withdrawal
Measure	RVL-1201 Ophthalmic Solution, 0.1% RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD for 84 days	Vehicle Ophthalmic Solution Vehicle placebo ophthalmic solution One drop each eye QD for 84 days
Overall Study Adverse Event	4	0
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	6	0
Overall Study Non-compliance	2	1

Baseline Characteristics

Study of Safety of RVL-1201 in Treatment of Blepharoptosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RVL-1201 Ophthalmic Solution, 0.1% n=157 Participants RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD for 84 days	Vehicle Ophthalmic Solution n=77 Participants Vehicle placebo ophthalmic solution One drop each eye QD for 84 days	Total n=234 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	65 Participants n=5 Participants	38 Participants n=7 Participants	103 Participants n=5 Participants
Age, Categorical >=65 years	90 Participants n=5 Participants	38 Participants n=7 Participants	128 Participants n=5 Participants
Age, Continuous	63.7 years STANDARD_DEVIATION 14.64 • n=5 Participants	63.3 years STANDARD_DEVIATION 14.63 • n=7 Participants	63.6 years STANDARD_DEVIATION 14.60 • n=5 Participants
Age, Customized	66 years n=5 Participants	64 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	126 Participants n=5 Participants	53 Participants n=7 Participants	179 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	24 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	143 Participants n=5 Participants	72 Participants n=7 Participants	215 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	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	137 Participants n=5 Participants	66 Participants n=7 Participants	203 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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
Region of Enrollment United States	157 Participants n=5 Participants	77 Participants n=7 Participants	234 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening/Day 1 to Day 84

Population: The safety population includes all subjects who receive at least one dose of double-masked study treatment and have at least one post-dose visit.

Outcome measures

Outcome measures
Measure	RVL-1201 Ophthalmic Solution, 0.1% n=157 Participants Participants with Acquired Blepharoptosis administered 1 drop of RVL-1201 in each eye once daily	Vehicle Ophthalmic Solution n=77 Participants Participants with Acquired Blepharoptosis administered 1 drop of Vehicle in each eye once daily
Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84 Mean Change from Baseline IOP (OD)	-0.6 mmHg Standard Deviation 2.40	-0.2 mmHg Standard Deviation 2.52
Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84 Mean Change from Baseline IOP (OS)	-0.6 mmHg Standard Deviation 2.42	-0.2 mmHg Standard Deviation 0.41

PRIMARY outcome

Timeframe: Screening/Day 1 to Day 84

Population: The safety population includes all subjects who receive at least one dose of double-masked study treatment and have at least one post-dose visit.

Pupil diameter will be measured in millimeters (either horizontally or vertically if top of pupil is not visible in photograph) from the external photograph.

Outcome measures

Outcome measures
Measure	RVL-1201 Ophthalmic Solution, 0.1% n=157 Participants Participants with Acquired Blepharoptosis administered 1 drop of RVL-1201 in each eye once daily	Vehicle Ophthalmic Solution n=77 Participants Participants with Acquired Blepharoptosis administered 1 drop of Vehicle in each eye once daily
Mean Change From Baseline in Pupil Diameter (PD) at Day 84 Mean Change From Baseline PD (OD)	0.0 Millimeters (mm) Standard Deviation 0.77	-0.1 Millimeters (mm) Standard Deviation 0.66
Mean Change From Baseline in Pupil Diameter (PD) at Day 84 Mean Change from Baseline PD (OS)	0.0 Millimeters (mm) Standard Deviation 0.77	-0.1 Millimeters (mm) Standard Deviation 0.59

Adverse Events

RVL-1201 Ophthalmic Solution, 0.1%

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Vehicle Ophthalmic Solution

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RVL-1201 Ophthalmic Solution, 0.1% n=157 participants at risk RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD for 84 days	Vehicle Ophthalmic Solution n=77 participants at risk Vehicle placebo ophthalmic solution One drop each eye QD for 84 days
Musculoskeletal and connective tissue disorders Arthralgia	0.64% 1/157 • Number of events 1 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).	0.00% 0/77 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).
Renal and urinary disorders Nephrolithiasis	0.64% 1/157 • Number of events 1 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).	0.00% 0/77 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).

Other adverse events

Other adverse events
Measure	RVL-1201 Ophthalmic Solution, 0.1% n=157 participants at risk RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD for 84 days	Vehicle Ophthalmic Solution n=77 participants at risk Vehicle placebo ophthalmic solution One drop each eye QD for 84 days
Eye disorders Dry eye	4.5% 7/157 • Number of events 12 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).	1.3% 1/77 • Number of events 2 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).
Eye disorders Conjunctival hyperaemia	3.2% 5/157 • Number of events 9 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).	0.00% 0/77 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).
Infections and infestations Nasopharyngitis	1.3% 2/157 • Number of events 2 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).	2.6% 2/77 • Number of events 2 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).
Investigations Vital dye staining cornea present	3.2% 5/157 • Number of events 7 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).	1.3% 1/77 • Number of events 1 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).
Nervous system disorders Headache	3.2% 5/157 • Number of events 5 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).	1.3% 1/77 • Number of events 1 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 84 (end of study). AEs spontaneously reported by the subject and/or in response to an open questions from the study personnel or revealed by observation were recorded in the electronic Case Report Form (eCRF).

Additional Information

Senior Director of Clinical Operations

RVL Pharmaceuticals, Inc.

Phone: 908-809-1423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60