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

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ClinicalTrials.gov Identifier: NCT03565887
Recruitment Status : Completed
First Posted : June 21, 2018
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
Information provided by (Responsible Party):
RVL Pharmaceuticals, Inc.

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 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 and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
Actual Study Start Date : June 28, 2018
Actual Primary Completion Date : April 11, 2019
Actual Study Completion Date : April 22, 2019

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

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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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

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

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): NCT03565887

Show Show 36 study locations
Sponsors and Collaborators
RVL Pharmaceuticals, Inc.
  Study Documents (Full-Text)

Documents provided by RVL Pharmaceuticals, Inc.:
Study Protocol  [PDF] October 9, 2018
Statistical Analysis Plan  [PDF] April 15, 2019

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Responsible Party: RVL Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03565887    
Other Study ID Numbers: RVL-1201-202
First Posted: June 21, 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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Eyelid Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions