Safety and Efficacy Study of RVL-1201 in Acquired Blepharoptosis

NCT01848041 | Completed Phase 1 Results

• 1 other identifier: RVL-1201-001
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory, proof of concept study to evaluate the safety and efficacy of RVL-1201 dosed once or twice daily for 14 days compared to a placebo (vehicle) control in patients with ptosis.

Conditions

Blepharoptosis

Keywords

Blepharoptosis; Ptosis

Outcome Measures

Primary Outcomes (1)

• Humphrey Visual Field

  The mean change from baseline (Day 0, Hour 0) in number of points seen on the HVF 36-point ptosis protocol test according to a pre-planned hierarchical analysis as follows: 1. Hour 6 on Visit 4 (Day 13) for the BID regimen versus vehicle 2. Hour 6 on Visit 4 (Day 13) for the QD regimen versus vehicle 3. Hour 2 on Visit 4 (Day 13) for the BID regimen versus vehicle 4. Hour 2 on Visit 4 (Day 13) for the QD regimen versus vehicle Testing was performed using a Humphrey perimeter at a grid of 36 points confined to the superior hemifield extending 55° to either side of fixation and 45° superior to fixation. Testing was accomplished in the standard fashion using a varying 4-mm2 or 5-mm2 stimulus to determine the visual sensitivity for each grid point in the field (Riemann et al, 2000). A 4-mm2 stimulus was acceptable, but a 5-mm2 stimulus was preferred, if available.

  Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)

Secondary Outcomes (4)

• Marginal Reflex Distance

  Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)

• Palpebral Fissure Distance Measurement

  Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)

• Contrast Sensitivity

  Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)

• Corrected Snellen Visual Acuity

  Baseline (Day 0, Hour 0), Visit 4 (Day 13, Hour 2) and Visit 4 (Day 13, Hour 6)

Study Arms (3)

RVL-1201 once daily

EXPERIMENTAL

RVL-1201 0.1% ophthalmic solution dosed one full drop per eye in the morning; one full drop of vehicle (placebo) per eye approximately 8 hours after the morning dose

Drug: RVL-1201

RVL-1201 twice daily

EXPERIMENTAL

RVL-1201 0.1% ophthalmic solution dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose

Drug: RVL-1201

RVL-1201 vehicle (placebo)

PLACEBO COMPARATOR

RVL 1201 ophthalmic solution vehicle (placebo) dosed one full drop per eye BID; approximately 8 hours between the morning dose and the afternoon dose

Drug: RVL-1201 Vehicle Placebo

Interventions

RVL-1201 DRUG

RVL-1201 0.1% Ophthalmic Solution

Also known as: Oxymetazoline Hydrochloride Ophthalmic Solution 0.1%

RVL-1201 once daily; RVL-1201 twice daily

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:

• Adult male or female subjects 18 years of age and older.
• Presence of all of the following at Screening:
• Loss on HVF 36-point ptosis protocol test of ≥ 8 points in points not seen at or above 10° from fixation in the superior visual field; AND

You may not qualify if:

• 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.
• Provide informed consent prior to undergoing any study-related procedures.
• In either eye:
• Congenital ptosis
• Pseudoptosis
• 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
• Dermatochalasis as the sole cause of the signs of ptosis
• Previous ptosis surgery
• Lid position affected by lid or conjunctival scarring
• Current use of prescribed dry eye medication or punctal plugs; artificial tears are allowed
• Visual field loss from any cause other than ptosis
• Inability to fixate on the central fixation target of the HVF

Sponsors & Collaborators

• RVL Pharmaceuticals, Inc.: lead

Study Sites (1)

Unknown Facility

Morrow, Georgia, 30260, United States

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Results Point of Contact

• Title: Sr. Director, Clinical Development
• Organization: RVL Pharmaceuticals

mvelasco@osmotica.com

908-809-1423

Study Officials

• Chuck Slonim, MD

  Oculos Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• 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 3, 2013
• First Posted: May 7, 2013
• Study Start: May 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 26, 2021
• Results First Posted: July 22, 2021

Record last verified: 2021-11

Locations

US (1)