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

NCT02436759 | Completed Phase 3 Results

• 1 other identifier: RVL-1201-201
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 14

Brief Summary

This is a Phase 3 study is to evaluate the safety and efficacy of RVL-1201 Ophthalmic Solution in the treatment of acquired blepharoptosis (ptosis) and to assess the safety and comfort of RVL-1201 Ophthalmic Solution for an extended dosing period of 6 weeks.

Conditions

Acquired Blepharoptosis

Outcome Measures

Primary Outcomes (1)

• 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).

  Mean change from Baseline (Day 1, Hour 0) compared with Day 1, Hour 6 and Day 14, Hour 2

Secondary Outcomes (1)

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

  Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42

Study Arms (2)

RVL-1201

EXPERIMENTAL

RVL-1201 Ophthalmic Solution 0.1% 1 drop per eye QD for 6 weeks

Drug: RVL-1201

RVL-1201 Vehicle Placebo

PLACEBO COMPARATOR

RVL-1201 Ophthalmic Solution vehicle (placebo) 1 drop per eye QD for 6 weeks

Drug: RVL-1201 Vehicle Placebo

Interventions

RVL-1201 DRUG

RVL-1201 Ophthalmic Solution 0.1%

Also known as: Oxymetazoline Hydrochloride Ophthalmic Solution 0.1%

RVL-1201

RVL-1201 Vehicle Placebo DRUG

RVL-1201 Vehicle Placebo

Also known as: RVL-1201 Ophthalmic Solution 0.1% Placebo

RVL-1201 Vehicle Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 18 years of age and older.
• Presence of all of the following at Screening :
• a. Loss on a reliable LPFT of ≥ 8 points in the top 2 rows (LPFT Eligibility Score); subjects must see at least 9 total points in the top 4 rows (LPFT Total Score).
• i. This criteria must be met at both the Visit 1 Hour 0 (V1H0) and Visit 1 Hour 6 (V1H6) LPFT assessments
• ii. There must be ≤ 4 points of variance between the V1H0 and the V1H6 LPFT Eligibility Score;; AND
• AND
• Presence of all of the following at Baseline:
• i. This criteria must be met at the Visit 2 Hour 0 (V2H0) LPFT assessment. ii. There must be ≤ 4 points of variance between the V1H6 and the V2H0 LPFT Eligibility Score;
• AND
• AND
• Female subjects must be 1 year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
• Able to self-administer study medication or to have the study medication administered by a caregiver throughout the study period.
• Subjects must be able to understand and sign an IRB approved informed consent form prior to participation in any study-related procedures.

You may not qualify if:

• In either eye
• Congenital ptosis.
• Presence of either of the following:
• Pseudoptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin) or
• Dermatochalasis that extends less than 3 mm above the upper eyelid margin.
• Horner syndrome.
• Marcus Gunn jaw winking syndrome.
• Myasthenia gravis.
• Mechanical ptosis, including ptosis due to orbital or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
• Previous ptosis surgery (previous blepharoplasty \[only\] is allowed provided the surgery took place \> 3 months prior to Visit 1).
• Lid position affected by lid or conjunctival scarring.
• Visual field loss from any cause other than ptosis.
• History of herpes keratitis.
• History of closed/narrow angle glaucoma (unless patent peripheral iridotomy has been performed \> 3 months prior to Visit 1).
• Periocular neurotoxin (eg, Botox, Xeomin, Dysport, Myobloc) injections within 3 months prior to Visit 1 and during the study.

Sponsors & Collaborators

• RVL Pharmaceuticals, Inc.: lead

Study Sites (14)

Unknown Facility

Artesia, California, 90701, United States

Location

Unknown Facility

Newport Beach, California, 92663, United States

Location

Unknown Facility

Rancho Cordova, California, 95670, United States

Location

Unknown Facility

Santa Maria, California, 93454, United States

Location

Unknown Facility

Fort Myers, Florida, 33901, United States

Location

Unknown Facility

Largo, Florida, 33773, United States

Location

Unknown Facility

Plantation, Florida, 33324, United States

Location

Unknown Facility

Sarasota, Florida, 34239, United States

Location

Unknown Facility

Roswell, Georgia, 30076, United States

Location

Unknown Facility

Pittsburg, Kansas, 66762, United States

Location

Unknown Facility

Shawnee Mission, Kansas, 66204, United States

Location

Unknown Facility

Mason, Ohio, 45040, United States

Location

Unknown Facility

Kingston, Pennsylvania, 18704, United States

Location

Unknown Facility

Nashville, Tennessee, 37215, United States

Location

Results Point of Contact

• Title: Senior Director of Clinical Operations
• Organization: RVL Pharmaceuticals, Inc.

mvelasco@osmotica.com

9088091423

Study Officials

• Chuck Slonim, MD

  Oculos Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 7, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 28, 2021
• Results First Posted: October 20, 2020

Record last verified: 2021-10

Locations

US (14)