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

Primary Purpose

Blepharoptosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
RVL-1201
Vehicle ophthalmic solution
Sponsored by
RVL Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blepharoptosis

Eligibility Criteria

9 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or Female 9 years of age or older
  2. Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception
  3. Must be able to self-administer study medication
  4. Must be able to understand and sign an informed consent form. For minor subjects, the subject's parent or legal guardian must provide permission by signing an ICF on behalf of the subject and the subject should provide assent.

Exclusion Criteria:

  1. Congenital ptosis
  2. Horner syndrome
  3. Myasthenia gravis
  4. Mechanical ptosis
  5. Previous ptosis surgery
  6. Resting heart rate outside the normal range
  7. Hypertension with resting diastolic blood pressure
  8. Pregnancy or lactation

Sites / Locations

  • Barnet, Dulany Perkins
  • Orange County Ophthalmology
  • North Valley Eye
  • Eye Research Foundation
  • Pendelton Eye Center
  • North Bay Eye Associates
  • Michael Tran
  • Danbury Eye Physicians
  • Hernando Eye Institute
  • Shettle Eye Research
  • West Coast Eye
  • Sabal Eye Care
  • Maitland Vision Center
  • Sarasota Retina Institute
  • East Florida Eye
  • Coastal Research Associates
  • Kennar Eye Care
  • Heart of America Eye
  • Seidenberg Protzko Eye
  • Mississippi Eye
  • Silverstein Eye
  • Comprehensive Eye Care
  • Rochester Ophthalmological
  • South Shore Eye
  • CEENTA
  • Cornerstone Eye
  • Quinn, Foster & Assoc.
  • Apex Eye
  • Apex Eye
  • Abrams Eye Center
  • Nashville vision Associates
  • Round Rock Eye
  • Texan Eye / Keystone
  • Lake Travis Eye
  • R&R Research
  • Medical Center Ophthalmology Assocs - Keystone Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RVL-1201 ophthalmic solution 0.1%

Vehicle ophthalmic solution

Arm Description

RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%

Vehicle placebo ophthalmic solution

Outcomes

Primary Outcome Measures

Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group
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).

Secondary Outcome Measures

Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye
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.

Full Information

First Posted
April 11, 2018
Last Updated
September 15, 2020
Sponsor
RVL Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03565887
Brief Title
Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis
Official Title
A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
April 11, 2019 (Actual)
Study Completion Date
April 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RVL Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Phase 3 study to evaluate the safety and efficacy of treatment with RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharoptosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RVL-1201 ophthalmic solution 0.1%
Arm Type
Experimental
Arm Description
RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%
Arm Title
Vehicle ophthalmic solution
Arm Type
Placebo Comparator
Arm Description
Vehicle placebo ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
RVL-1201
Intervention Description
RVL-1201 ophthalmic solution 0.1%
Intervention Type
Other
Intervention Name(s)
Vehicle ophthalmic solution
Intervention Description
Vehicle placebo ophthalmic solution
Primary Outcome Measure Information:
Title
Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group
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)
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye
Description
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.
Time Frame
Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female 9 years of age or older Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception Must be able to self-administer study medication Must be able to understand and sign an informed consent form. For minor subjects, the subject's parent or legal guardian must provide permission by signing an ICF on behalf of the subject and the subject should provide assent. Exclusion Criteria: Congenital ptosis Horner syndrome Myasthenia gravis Mechanical ptosis Previous ptosis surgery Resting heart rate outside the normal range Hypertension with resting diastolic blood pressure Pregnancy or lactation
Facility Information:
Facility Name
Barnet, Dulany Perkins
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Orange County Ophthalmology
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
North Valley Eye
City
Mission Hills
State/Province
California
ZIP/Postal Code
941345
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Pendelton Eye Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
North Bay Eye Associates
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Michael Tran
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Danbury Eye Physicians
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Hernando Eye Institute
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34615
Country
United States
Facility Name
Shettle Eye Research
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
West Coast Eye
City
Lecanto
State/Province
Florida
ZIP/Postal Code
34461
Country
United States
Facility Name
Sabal Eye Care
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Maitland Vision Center
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
East Florida Eye
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Facility Name
Coastal Research Associates
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Kennar Eye Care
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Heart of America Eye
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
Facility Name
Seidenberg Protzko Eye
City
Havre De Grace
State/Province
Maryland
ZIP/Postal Code
21078
Country
United States
Facility Name
Mississippi Eye
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
Facility Name
Silverstein Eye
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
Facility Name
Comprehensive Eye Care
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Rochester Ophthalmological
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
South Shore Eye
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
CEENTA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cornerstone Eye
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Quinn, Foster & Assoc.
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States
Facility Name
Apex Eye
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45243
Country
United States
Facility Name
Apex Eye
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45247
Country
United States
Facility Name
Abrams Eye Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Nashville vision Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Round Rock Eye
City
Austin
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Texan Eye / Keystone
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Lake Travis Eye
City
Lakeway
State/Province
Texas
ZIP/Postal Code
78734
Country
United States
Facility Name
R&R Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Medical Center Ophthalmology Assocs - Keystone Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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