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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02436759
Recruitment Status : Completed
First Posted : May 7, 2015
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
RVL Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acquired Blepharoptosis
Interventions Drug: RVL-1201
Drug: RVL-1201 Vehicle Placebo
Enrollment 140
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title RVL-1201 Vehicle
Hide Arm/Group Description RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
Period Title: Overall Study
Started 94 46
Subjects Randomized 94 46
Subjects Treated 94 46
Completed 90 45
Not Completed 4 1
Reason Not Completed
Adverse Event             3             0
Protocol Violation             1             0
Withdrawal by Subject             0             1
Arm/Group Title RVL-1201 Vehicle Total
Hide Arm/Group Description RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning Total of all reporting groups
Overall Number of Baseline Participants 94 46 140
Hide Baseline Analysis Population Description
Intent to Treat (ITT) Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 46 participants 140 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
  40.4%
22
  47.8%
60
  42.9%
>=65 years
56
  59.6%
24
  52.2%
80
  57.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 94 participants 46 participants 140 participants
64.7  (12.22) 63.2  (12.45) 64.2  (12.28)
Age, Customized  
Measure Type: Number
Unit of measure:  Years
Number Analyzed 94 participants 46 participants 140 participants
Median 68.0 65.5 67.0
Minimum 22 26 22
Maximum 83 85 85
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 46 participants 140 participants
Female
74
  78.7%
32
  69.6%
106
  75.7%
Male
20
  21.3%
14
  30.4%
34
  24.3%
[1]
Measure Description: Intent to Treat (ITT) Population
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 46 participants 140 participants
Hispanic or Latino
20
  21.3%
11
  23.9%
31
  22.1%
Not Hispanic or Latino
74
  78.7%
35
  76.1%
109
  77.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 46 participants 140 participants
American Indian or Alaska Native
2
   2.1%
0
   0.0%
2
   1.4%
Asian
2
   2.1%
1
   2.2%
3
   2.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
12
  12.8%
0
   0.0%
12
   8.6%
White
78
  83.0%
3
   6.5%
81
  57.9%
More than one race
0
   0.0%
42
  91.3%
42
  30.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 94 participants 46 participants 140 participants
94 46 140
Iris Color OD (right eye) and Iris Color OS (left eye)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 46 participants 140 participants
OD/OS Blue
23
  24.5%
14
  30.4%
37
  26.4%
OD/OS Brown
55
  58.5%
22
  47.8%
77
  55.0%
OD/OS Green
4
   4.3%
1
   2.2%
5
   3.6%
OD/OS Hazel
12
  12.8%
9
  19.6%
21
  15.0%
OD/OS Grey
0
   0.0%
0
   0.0%
0
   0.0%
OD/OS Other
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group
Hide Description 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).
Time Frame Mean change from Baseline (Day 1, Hour 0) compared with Day 1, Hour 6 and Day 14, Hour 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RVL-1201 Vehicle Ophthalmic Solution
Hide Arm/Group Description:
RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning
Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
Overall Number of Participants Analyzed 94 46
Mean (Standard Deviation)
Unit of Measure: Points seen
Mean LPFT-Day 1 Hour 6 5.2  (5.97) 1.5  (3.93)
Mean LPFT-Day 14 Hour 2 6.4  (5.04) 2.2  (5.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RVL-1201, Vehicle Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Two-sided t-test with treatment as a fixed factor and baseline score as a covariate
2.Secondary Outcome
Title Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye
Hide Description 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.
Time Frame Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title RVL-1201 Vehicle Ophthalmic Solution
Hide Arm/Group Description:
RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning
Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
Overall Number of Participants Analyzed 94 46
Mean (Standard Deviation)
Unit of Measure: Millimeters (mm)
Primary Efficacy - Day 1, Hour 6 0.94  (0.924) 0.67  (1.001)
Primary Efficacy - Day 14, Hour 2 1.09  (0.799) 0.58  (0.975)
Post Dose - Day 1, Hour 2 0.99  (0.776) 0.50  (0.803)
Post Dose - Day 1, Hour 8 0.93  (0.958) 0.70  (0.771)
Post Dose - Day 14, Hour 6 1.03  (0.856) 0.70  (0.985)
Post Dose - Day 14, Hour 8 0.88  (0.857) 0.68  (1.023)
Post Dose - Day 42 1.25  (1.036) 0.79  (1.020)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RVL-1201, Vehicle Ophthalmic Solution
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments Two-sided t-test
Time Frame Duration of treatment is 6 weeks (42 Days)
Adverse Event Reporting Description 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).
 
Arm/Group Title RVL-1201 Vehicle
Hide Arm/Group Description RVL-1201 (oxymetazoline hydrochloride) Ophthalmic Solution 0.1%, one drop each eye QD in the morning Vehicle Placebo Ophthalmic Solution, one drop each eye QD in the morning
All-Cause Mortality
RVL-1201 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)      0/46 (0.00%)    
Hide Serious Adverse Events
RVL-1201 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/94 (1.06%)      0/46 (0.00%)    
Endocrine disorders     
Hyperparathyroidism * 1  1/94 (1.06%)  1 0/46 (0.00%)  0
1
Term from vocabulary, Dictionary Version M
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
RVL-1201 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/94 (21.28%)      15/46 (32.61%)    
Cardiac disorders     
Atrial fibrilation * 1  0/94 (0.00%)  0 1/46 (2.17%)  1
Eye disorders     
Punctate keratitis * 1  7/94 (7.45%)  11 2/46 (4.35%)  2
Vision blurred * 1  5/94 (5.32%)  10 0/46 (0.00%)  0
Ocular hyperaemia * 1  3/94 (3.19%)  5 0/46 (0.00%)  0
Conjunctival haemorrhage * 1  1/94 (1.06%)  1 1/46 (2.17%)  1
Diabetic retinopathy * 1  0/94 (0.00%)  0 1/46 (2.17%)  2
Dry eye * 1  0/94 (0.00%)  0 1/46 (2.17%)  2
Erythema of eyelid * 1  0/94 (0.00%)  0 1/46 (2.17%)  2
Eye pruritus * 1  0/94 (0.00%)  0 1/46 (2.17%)  2
Foreign body sensation * 1  0/94 (0.00%)  0 1/46 (2.17%)  1
Iritis * 1  0/94 (0.00%)  0 1/46 (2.17%)  1
Vitreous detachment * 1  0/94 (0.00%)  0 2/46 (4.35%)  2
General disorders     
Instillation site pain * 1  4/94 (4.26%)  8 0/46 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection * 1  2/94 (2.13%)  2 1/46 (2.17%)  1
Bronchitis * 1  0/94 (0.00%)  0 1/46 (2.17%)  1
Nasopharyngitis * 1  0/94 (0.00%)  0 1/46 (2.17%)  1
Pneumonia * 1  0/94 (0.00%)  0 1/46 (2.17%)  1
Sinusitis * 1  0/94 (0.00%)  0 1/46 (2.17%)  1
Investigations     
Vital dye staining cornea present * 1  2/94 (2.13%)  4 0/46 (0.00%)  0
Metabolism and nutrition disorders     
Hypoglycaemia * 1  0/94 (0.00%)  0 1/46 (2.17%)  1
Nervous system disorders     
Headache * 1  2/94 (2.13%)  2 0/46 (0.00%)  0
Dysgeusia * 1  0/94 (0.00%)  0 1/46 (2.17%)  1
Psychiatric disorders     
Stress * 1  0/94 (0.00%)  0 1/46 (2.17%)  1
Vascular disorders     
Hypertension * 1  0/94 (0.00%)  0 1/46 (2.17%)  1
1
Term from vocabulary, MedDRA 21.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director of Clinical Operations
Organization: RVL Pharmaceuticals, Inc.
Phone: 9088091423
EMail: mvelasco@osmotica.com
Layout table for additonal information
Responsible Party: RVL Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02436759    
Other Study ID Numbers: RVL-1201-201
First Submitted: May 4, 2015
First Posted: May 7, 2015
Results First Submitted: September 25, 2020
Results First Posted: October 20, 2020
Last Update Posted: October 20, 2020