BlepharoptosisPhase 3NCT03536949
Study of Safety of RVL-1201 in Treatment of Blepharoptosis
A Phase 3 study testing RVL-1201 in people with Blepharoptosis, run by RVL Pharmaceuticals, Inc. at 35 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Blepharoptosis
- What is being tested?
- RVL-1201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 35 sitesUnited States
- Study dates
- 20 Jun 2018to 27 Mar 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or Female 9 years of age or older
- Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception
- Must be able to self-administer study medication
- 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.
Who cannot join
- Congenital ptosis
- Horner syndrome
- Myasthenia gravis
- Mechanical ptosis
- Previous ptosis surgery
- Resting heart rate outside the normal range
- Hypertension with resting diastolic blood pressure
- Pregnancy or lactation
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Drs. Quinn, Foster & Associates
Athens, Ohio, 45701
Round Rock Eye Consultants
Austin, Texas, 78681
Texan Eye / Keystone Research, Ltd.
Austin, Texas, 78731
Hernando Eye Institute
Brooksville, Florida, 34615
CEENTA
Charlotte, North Carolina, 28210
Apex Eye
Cincinnati, Ohio, 45243
Apex Eye
Cincinnati, Ohio, 45247
Abrams Eye Center
Cleveland, Ohio, 44115
Danbury Eye Physicians and Surgeons
Danbury, Connecticut, 06810
Orange County Ophthalmology Medical Group
Garden Grove, California, 92843
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078
Cornerstone Eye Care
High Point, North Carolina, 27262
Silverstein Eye Centers
Kansas City, Missouri, 64133
Lake Travis Eye and Laser Center
Lakeway, Texas, 78734-5304
Shettle Eye Research
Largo, Florida, 33773
West Coast Eye Institute
Lecanto, Florida, 34461
Sabal Eye Care
Longwood, Florida, 32779
Maitland Vision Center
Maitland, Florida, 32751
North Valley Eye Medical
Mission Hills, California, 91345
Nashville Vision Associates
Nashville, Tennessee, 37205
Eye Research Foundation
Newport Beach, California, 92663
Mississippi Eye Associates
Ocean Springs, Mississippi, 39564
Pendelton Eye Center
Oceanside, California, 92056
North Bay Eye Associates
Petaluma, California, 94954
Barnet, Dulany Perkins
Phoenix, Arizona, 85016
Kennar Eye Care
Pittsburg, Kansas, 66762
Rochester Ophthalmological Group
Rochester, New York, 14618
Coastal Research Associates
Roswell, Georgia, 30076
R & R Research
San Antonio, Texas, 78229
Sarasota Retina Institute
Sarasota, Florida, 34239
Heart of America Eye Care
Shawnee Mission, Kansas, 66204
East Florida Eye Institute
Stuart, Florida, 34994
South Shore Eye Care
Wantagh, New York, 11793
Comprehensive Eye Care
Washington, Missouri, 63090
Michael K. Tran, MD Inc.
Westminster, California, 92683
About this study
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)
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.
- Conditions
- Blepharoptosis
- Being tested
- RVL-1201, Vehicle ophthalmic solution
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVL-1201Drug
RVL-1201 ophthalmic solution, 0.1%
Vehicle ophthalmic solutionOther
Vehicle placebo ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| RVL-1201 Ophthalmic Solution, 0.1% | Experimental | RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% Receives: Drug: RVL-1201 |
| Vehicle ophthalmic solution | Placebo comparator | Vehicle placebo ophthalmic solution Receives: Other: Vehicle ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Intraocular Pressure (IOP) at 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.
Measured: Screening/Day 1 to Day 84
Mean Change From Baseline in Pupil Diameter (PD) at 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.
Measured: Screening/Day 1 to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start20 Jun 2018
- Primary completion14 Mar 2019
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BlepharoptosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- RVL Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536949
- Sponsor's protocol ID
- RVL-1201-203
- Status last verified
- Sep 2020
- First submitted
- 11 Apr 2018
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03536949
- Acronym / sponsor ID
- RVL-1201-203
- Conditions
- Blepharoptosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- RVL Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 25 May 2018 (actual)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RVL-1201 Ophthalmic Solution, 0.1% | Experimental | Drug: RVL-1201RVL-1201 (oxymetazoline hydrochloride) ophthalmic solution 0.1% |
| Vehicle ophthalmic solution | Placebo comparator | Other: Vehicle ophthalmic solutionVehicle placebo ophthalmic solution |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female 9 years of age or older
- Females must not be pregnant or planning to get pregnant and must use acceptable form of contraception
- Must be able to self-administer study medication
- 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.
Key exclusion criteria (8 listed)
- Congenital ptosis
- Horner syndrome
- Myasthenia gravis
- Mechanical ptosis
- Previous ptosis surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RVL-1201RVL-1201 ophthalmic solution, 0.1% | Drug | RVL-1201 Ophthalmic Solution, 0.1% |
| Vehicle ophthalmic solutionVehicle placebo ophthalmic solution | Other | Vehicle ophthalmic solution |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RVL-1201 in people with Blepharoptosis, run by RVL Pharmaceuticals, Inc. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Intraocular Pressure (IOP) at Day 84 (time frame: Screening/Day 1 to Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.