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Study of Safety and Efficacy of RVL-1201 in the Treatment of 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: NCT03565887
Recruitment Status : Completed
First Posted : June 21, 2018
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
RVL Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE June 21, 2018
Results First Submitted Date  ICMJE August 4, 2020
Results First Posted Date  ICMJE September 16, 2020
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE June 28, 2018
Actual Primary Completion Date April 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2020)
Mean Change in Number of Points Seen on the Leicester Peripheral Field Test (LPFT) in RVL-1201 Group vs. Vehicle Group [ Time Frame: Mean change from Baseline (Day 1, Hour 0) compared with Day 1, (Hour 6), and Day 14 (Hour 2) ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
Mean change in number of points seen on the LPFT in RVL group vs. Vehicle group [ Time Frame: 1 day and 14 days ]
Mean change from Baseline in LPFT test at Visit 2 and Visit 3
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2020)
Mean Change From Baseline in Marginal Reflex Distance (MRD) in the Study Eye [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
Change in Marginal Reflex Distance (MRD) [ Time Frame: 42 days ]
Mean observed values and change from baseline values for MRD
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: June 20, 2018)
  • Pupil diameter comparisons of RVL-1201 with vehicle [ Time Frame: 42 days ]
    Comparison of RVL-1201 to vehicle for ophthalmic safety assessment pupil diameter.
  • Change in tonometry comparisons of RVL-1201 with vehicle [ Time Frame: 42 days ]
    Comparison of RVL-1201 to vehicle for ophthalmic safety assessment tonometry.
  • Change in blood pressure comparisons of RVL-1201 with vehicle [ Time Frame: 42 days ]
    Comparison of RVL-1201 to vehicle for blood pressures.
 
Descriptive Information
Brief Title  ICMJE Study of Safety and Efficacy of RVL-1201 in the Treatment of Blepharoptosis
Official Title  ICMJE A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Blepharoptosis
Intervention  ICMJE
  • Drug: RVL-1201
    RVL-1201 ophthalmic solution 0.1%
  • Other: Vehicle ophthalmic solution
    Vehicle placebo ophthalmic solution
Study Arms  ICMJE
  • Experimental: RVL-1201 ophthalmic solution 0.1%
    RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%
    Intervention: Drug: RVL-1201
  • Placebo Comparator: Vehicle ophthalmic solution
    Vehicle placebo ophthalmic solution
    Intervention: Other: Vehicle ophthalmic solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2019)
164
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2018)
156
Actual Study Completion Date  ICMJE April 22, 2019
Actual Primary Completion Date April 11, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03565887
Other Study ID Numbers  ICMJE RVL-1201-202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RVL Pharmaceuticals, Inc.
Study Sponsor  ICMJE RVL Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account RVL Pharmaceuticals, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP