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Study of Safety of RVL-1201 in 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: NCT03536949
Recruitment Status : Completed
First Posted : May 25, 2018
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
RVL Pharmaceuticals, Inc.

Study Description
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Brief Summary:
Phase 3 study to evaluate the extended safety of RVL-1201 compared to placebo for treatment of blepharoptosis. Eligible subjects will be randomized to one of 2 treatment arms.

Condition or disease Intervention/treatment Phase
Blepharoptosis Drug: RVL-1201 Other: Vehicle ophthalmic solution Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Safety of RVL-1201 in the Treatment of Acquired Blepharoptosis (Study RVL-1201-203)
Actual Study Start Date : June 20, 2018
Actual Primary Completion Date : March 14, 2019
Actual Study Completion Date : March 27, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: RVL-1201 Ophthalmic Solution, 0.1%
RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1%
 Drug: RVL-1201
RVL-1201 ophthalmic solution, 0.1%
Placebo Comparator: Vehicle ophthalmic solution
Vehicle placebo ophthalmic solution
 Other: Vehicle ophthalmic solution
Vehicle placebo ophthalmic solution


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84 [ Time Frame: Screening/Day 1 to Day 84 ]
    Intraocular pressure will be measured in mmHg utilizing a tonometer and using the standard of care. If possible, the same calibrated instrument should be used for a given subject throughout the study.

  2. Mean Change From Baseline in Pupil Diameter (PD) at Day 84 [ Time Frame: Screening/Day 1 to Day 84 ]
    Pupil diameter will be measured in millimeters (either horizontally or vertically if top of pupil is not visible in photograph) from the external photograph.


Eligibility Criteria
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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (ICF). 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536949


Locations
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Sponsors and Collaborators
RVL Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by RVL Pharmaceuticals, Inc.:
Study Protocol  [PDF] October 24, 2018
Statistical Analysis Plan  [PDF] November 20, 2018

More Information
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Responsible Party: RVL Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03536949    
Other Study ID Numbers: RVL-1201-203
First Posted: May 25, 2018    Key Record Dates
Results First Posted: September 16, 2020
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Blepharoptosis
Eyelid Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions