Trial Outcomes & Findings for Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis (NCT NCT03565887)

Last Updated: 2020-09-16

Results Overview

LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

164 participants

Primary outcome timeframe

Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2)

Results posted on

2020-09-16

Participant Flow

Planned sample size was approximately 156 subjects, 104 subjects in the RVL-1201 group, and 52 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 once-daily in the morning	Vehicle Ophthalmic Solution Vehicle placebo ophthalmic Solution One drop each eye once-daily in the morning
Overall Study STARTED	109	55
Overall Study COMPLETED	108	53
Overall Study NOT COMPLETED	1	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 once-daily in the morning	Vehicle Ophthalmic Solution Vehicle placebo ophthalmic Solution One drop each eye once-daily in the morning
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RVL-1201 Ophthalmic Solution 0.1% n=109 Participants RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD in the morning	Vehicle Ophthalmic Solution n=55 Participants Vehicle placebo ophthalmic Solution One drop each eye QD in the morning	Total n=164 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=99 Participants	22 Participants n=107 Participants	68 Participants n=206 Participants
Age, Categorical >=65 years	63 Participants n=99 Participants	32 Participants n=107 Participants	95 Participants n=206 Participants
Age, Continuous	63.6 years STANDARD_DEVIATION 14.31 • n=99 Participants	63.3 years STANDARD_DEVIATION 16.51 • n=107 Participants	63.5 years STANDARD_DEVIATION 15.03 • n=206 Participants
Age, Customized	67.0 years n=99 Participants	67.0 years n=107 Participants	67.0 years n=206 Participants
Sex: Female, Male Female	77 Participants n=99 Participants	39 Participants n=107 Participants	116 Participants n=206 Participants
Sex: Female, Male Male	32 Participants n=99 Participants	16 Participants n=107 Participants	48 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=99 Participants	6 Participants n=107 Participants	19 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	96 Participants n=99 Participants	49 Participants n=107 Participants	145 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	6 Participants n=99 Participants	3 Participants n=107 Participants	9 Participants n=206 Participants
Race (NIH/OMB) White	99 Participants n=99 Participants	50 Participants n=107 Participants	149 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	109 participants n=99 Participants	55 participants n=107 Participants	164 participants n=206 Participants
Iris Color OD (right eye) OD-Blue	40 Participants n=99 Participants	18 Participants n=107 Participants	58 Participants n=206 Participants
Iris Color OD (right eye) OD-Brown	46 Participants n=99 Participants	18 Participants n=107 Participants	64 Participants n=206 Participants
Iris Color OD (right eye) OD-Green	7 Participants n=99 Participants	3 Participants n=107 Participants	10 Participants n=206 Participants
Iris Color OD (right eye) OD-Hazel	15 Participants n=99 Participants	15 Participants n=107 Participants	30 Participants n=206 Participants
Iris Color OD (right eye) OD-Grey	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Iris Color OS (left eye) OS-Blue	40 Participants n=99 Participants	18 Participants n=107 Participants	58 Participants n=206 Participants
Iris Color OS (left eye) OS-Brown	47 Participants n=99 Participants	18 Participants n=107 Participants	65 Participants n=206 Participants
Iris Color OS (left eye) OS-Green	6 Participants n=99 Participants	3 Participants n=107 Participants	9 Participants n=206 Participants
Iris Color OS (left eye) OS-Hazel	15 Participants n=99 Participants	15 Participants n=107 Participants	30 Participants n=206 Participants
Iris Color OS (left eye) OS-Grey	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants

PRIMARY outcome

Timeframe: Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2)

Population: Intent-to-Treat (ITT) population: randomized who received at least one dose. Per-Protocol Population (PPP): ITT population with no major protocol deviations (eleven subjects were excluded). ITT analysis was conducted for the primary endpoint, with Last Observation Carried Forward (LOCF) for missing data.

LPFT Total Score is the number of points seen in the top 4 rows on the LPFT. Possible scores range from 0 (no points seen) to 35 (all points seen).

Outcome measures

Outcome measures
Measure	RVL-1201 Ophthalmic Solution 0.1% n=109 Participants RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD in the morning	Vehicle Ophthalmic Solution n=55 Participants Vehicle placebo ophthalmic Solution One drop each eye QD in the morning
Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group Mean change from baseline LPFT-Day 1 Hour 6	6.3 Points seen Standard Deviation 6.72	2.1 Points seen Standard Deviation 4.28
Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group Mean change from baseline LPFT-Day 14 Hour 2	7.7 Points seen Standard Deviation 6.41	2.4 Points seen Standard Deviation 5.26

SECONDARY outcome

Timeframe: Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42

The Marginal Reflex Distance (MRD) is the distance from the center pupillary light reflex to the central margin of the upper eyelid. The MRD is measured from an external photograph using a handheld caliper and a millimeter ruler label placed on the subject's forehead as a measurement legend.

Outcome measures

Outcome measures
Measure	RVL-1201 Ophthalmic Solution 0.1% n=109 Participants RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% One drop each eye QD in the morning	Vehicle Ophthalmic Solution n=55 Participants Vehicle placebo ophthalmic Solution One drop each eye QD in the morning
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Day 1, Minute 5	0.59 Millimeters (mm) Standard Deviation 0.721	0.20 Millimeters (mm) Standard Deviation 0.571
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Day 1, Minute 15	0.93 Millimeters (mm) Standard Deviation 0.811	0.32 Millimeters (mm) Standard Deviation 0.641
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Day 1, Hour 2	1.05 Millimeters (mm) Standard Deviation 0.903	0.33 Millimeters (mm) Standard Deviation 0.555
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Day 1, Hour 6	0.98 Millimeters (mm) Standard Deviation 0.867	0.35 Millimeters (mm) Standard Deviation 0.567
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Day 14, Minute 5	0.77 Millimeters (mm) Standard Deviation 0.853	0.42 Millimeters (mm) Standard Deviation 0.775
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Day 14, Minute 15	1.11 Millimeters (mm) Standard Deviation 0.922	0.41 Millimeters (mm) Standard Deviation 0.833
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Day 14, Hour 2	1.22 Millimeters (mm) Standard Deviation 0.926	0.43 Millimeters (mm) Standard Deviation 0.734
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Day 14, Hour 6	1.06 Millimeters (mm) Standard Deviation 0.902	0.47 Millimeters (mm) Standard Deviation 0.737
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Day 42, Minute 5	0.86 Millimeters (mm) Standard Deviation 0.849	0.42 Millimeters (mm) Standard Deviation 0.799
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Day 42, Minute 15	1.04 Millimeters (mm) Standard Deviation 0.912	0.47 Millimeters (mm) Standard Deviation 0.926

Adverse Events

RVL-1201 Ophthalmic Solution, 0.1%

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Vehicle Ophthalmic Solution

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RVL-1201 Ophthalmic Solution, 0.1% n=109 participants at risk One drop each eye QD in the morning (n=109)	Vehicle Ophthalmic Solution n=55 participants at risk One drop each eye QD in the morning (n=55)
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/109 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.
Nervous system disorders Cerebrovascular accident	0.92% 1/109 • Number of events 1 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.	0.00% 0/55 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.

Other adverse events

Other adverse events
Measure	RVL-1201 Ophthalmic Solution, 0.1% n=109 participants at risk One drop each eye QD in the morning (n=109)	Vehicle Ophthalmic Solution n=55 participants at risk One drop each eye QD in the morning (n=55)
Eye disorders Conjunctival hyperaemia	5.5% 6/109 • Number of events 10 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.	1.8% 1/55 • Number of events 2 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.
Eye disorders Punctate keratitis	3.7% 4/109 • Number of events 8 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.	1.8% 1/55 • Number of events 1 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.
Eye disorders Eye pain	2.8% 3/109 • Number of events 4 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.	0.00% 0/55 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.
Eye disorders Eye pruritus	0.00% 0/109 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.	3.6% 2/55 • Number of events 4 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.
General disorders Instillation site complication	0.00% 0/109 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.	3.6% 2/55 • Number of events 4 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.
Investigations Vital dye straining cornea present	0.92% 1/109 • Number of events 2 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 eCRF.	5.5% 3/55 • Number of events 4 • Treatment-emergent adverse events (AEs) were assessed at Baseline through Day 42 (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 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