Trial Outcomes & Findings for Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis (NCT NCT02436759)

Last Updated: 2021-10-28

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

140 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

2021-10-28

Participant Flow

Planned sample size approx 150 subjects, 100 subjects in the RVL-1201 group, and 50 in the Vehicle group, to be enrolled at approx 20 clinical sites in the US.

Participant milestones

Participant milestones
Measure	RVL-1201 RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning	Vehicle Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
Overall Study STARTED	94	46
Overall Study Subjects Randomized	94	46
Overall Study Subjects Treated	94	46
Overall Study COMPLETED	90	45
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	RVL-1201 RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning	Vehicle Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
Overall Study Adverse Event	3	0
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RVL-1201 n=94 Participants RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning	Vehicle n=46 Participants Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning	Total n=140 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	38 Participants n=5 Participants	22 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	56 Participants n=5 Participants	24 Participants n=7 Participants	80 Participants n=5 Participants
Age, Continuous	64.7 years STANDARD_DEVIATION 12.22 • n=5 Participants	63.2 years STANDARD_DEVIATION 12.45 • n=7 Participants	64.2 years STANDARD_DEVIATION 12.28 • n=5 Participants
Age, Customized Median	68.0 years n=5 Participants	65.5 years n=7 Participants	67.0 years n=5 Participants
Age, Customized Minimum	22 years n=5 Participants	26 years n=7 Participants	22 years n=5 Participants
Age, Customized Maximum	83 years n=5 Participants	85 years n=7 Participants	85 years n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	32 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	11 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants	35 Participants n=7 Participants	109 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 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	12 Participants n=5 Participants	0 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	78 Participants n=5 Participants	3 Participants n=7 Participants	81 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	42 Participants n=7 Participants	42 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	94 participants n=5 Participants	46 participants n=7 Participants	140 participants n=5 Participants
Iris Color OD (right eye) and Iris Color OS (left eye) OD/OS Blue	23 Participants n=5 Participants	14 Participants n=7 Participants	37 Participants n=5 Participants
Iris Color OD (right eye) and Iris Color OS (left eye) OD/OS Brown	55 Participants n=5 Participants	22 Participants n=7 Participants	77 Participants n=5 Participants
Iris Color OD (right eye) and Iris Color OS (left eye) OD/OS Green	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Iris Color OD (right eye) and Iris Color OS (left eye) OD/OS Hazel	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Iris Color OD (right eye) and Iris Color OS (left eye) OD/OS Grey	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Iris Color OD (right eye) and Iris Color OS (left eye) OD/OS Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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 (total of 140 subjects). Per-Protocol Population (PPP): ITT population with no major protocol deviations (total of 139 subjects). 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 n=94 Participants RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning	Vehicle Ophthalmic Solution n=46 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 LPFT-Day 1 Hour 6	5.2 Points seen Standard Deviation 5.97	1.5 Points seen Standard Deviation 3.93
Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group Mean LPFT-Day 14 Hour 2	6.4 Points seen Standard Deviation 5.04	2.2 Points seen Standard Deviation 5.80

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	RVL-1201 n=94 Participants RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning	Vehicle Ophthalmic Solution n=46 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 Primary Efficacy - Day 1, Hour 6	0.94 Millimeters (mm) Standard Deviation 0.924	0.67 Millimeters (mm) Standard Deviation 1.001
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Primary Efficacy - Day 14, Hour 2	1.09 Millimeters (mm) Standard Deviation 0.799	0.58 Millimeters (mm) Standard Deviation 0.975
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Post Dose - Day 1, Hour 2	0.99 Millimeters (mm) Standard Deviation 0.776	0.50 Millimeters (mm) Standard Deviation 0.803
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Post Dose - Day 1, Hour 8	0.93 Millimeters (mm) Standard Deviation 0.958	0.70 Millimeters (mm) Standard Deviation 0.771
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Post Dose - Day 14, Hour 6	1.03 Millimeters (mm) Standard Deviation 0.856	0.70 Millimeters (mm) Standard Deviation 0.985
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Post Dose - Day 14, Hour 8	0.88 Millimeters (mm) Standard Deviation 0.857	0.68 Millimeters (mm) Standard Deviation 1.023
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye Post Dose - Day 42	1.25 Millimeters (mm) Standard Deviation 1.036	0.79 Millimeters (mm) Standard Deviation 1.020

Adverse Events

RVL-1201

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	RVL-1201 n=94 participants at risk RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning	Vehicle n=46 participants at risk Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
Endocrine disorders Hyperparathyroidism	1.1% 1/94 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	0.00% 0/46 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).

Other adverse events

Additional Information

Senior Director of Clinical Operations

RVL Pharmaceuticals, Inc.

Phone: 9088091423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	RVL-1201 n=94 participants at risk RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning	Vehicle n=46 participants at risk Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
Cardiac disorders Atrial fibrilation	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Eye disorders Punctate keratitis	7.4% 7/94 • Number of events 11 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	4.3% 2/46 • Number of events 2 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Eye disorders Vision blurred	5.3% 5/94 • Number of events 10 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	0.00% 0/46 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Eye disorders Ocular hyperaemia	3.2% 3/94 • Number of events 5 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	0.00% 0/46 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Eye disorders Conjunctival haemorrhage	1.1% 1/94 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Eye disorders Diabetic retinopathy	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 2 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Eye disorders Dry eye	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 2 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Eye disorders Erythema of eyelid	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 2 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Eye disorders Eye pruritus	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 2 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Eye disorders Foreign body sensation	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Eye disorders Iritis	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Eye disorders Vitreous detachment	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	4.3% 2/46 • Number of events 2 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
General disorders Instillation site pain	4.3% 4/94 • Number of events 8 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	0.00% 0/46 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Infections and infestations Upper respiratory tract infection	2.1% 2/94 • Number of events 2 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Infections and infestations Bronchitis	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Infections and infestations Nasopharyngitis	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Infections and infestations Pneumonia	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Infections and infestations Sinusitis	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Investigations Vital dye staining cornea present	2.1% 2/94 • Number of events 4 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	0.00% 0/46 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Nervous system disorders Headache	2.1% 2/94 • Number of events 2 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	0.00% 0/46 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Nervous system disorders Dysgeusia	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Psychiatric disorders Stress	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).
Vascular disorders Hypertension	0.00% 0/94 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).	2.2% 1/46 • Number of events 1 • Duration of treatment is 6 weeks (42 Days) Adverse Events (AEs) spontaneously reported by the subject and/or in response to open-ended questions from study personnel or revealed by observation and are recorded in the Case Report Form (CRF).