Acquired BlepharoptosisPhase 3NCT02436759
Study of the Safety and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
A Phase 3 study testing RVL-1201 in people with Acquired Blepharoptosis, run by RVL Pharmaceuticals, Inc. at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Blepharoptosis
- What is being tested?
- RVL-1201
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 14 sitesUnited States
- Study dates
- May 2015to Nov 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 years of age and older.
- Presence of all of the following at Screening :
- 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).
- This criteria must be met at both the Visit 1 Hour 0 (V1H0) and Visit 1 Hour 6 (V1H6) LPFT assessments
- There must be ≤ 4 points of variance between the V1H0 and the V1H6 LPFT Eligibility Score;; AND
- The MRD, the distance from the central pupillary light reflex to the central margin of the upper lid, must be ≤ 2 mm (no visible central pupillary light reflex defaults to 0) in the same eye as Inclusion Criterion #2a
Show all 18Show fewer
- AND
- Snellen visual acuity (VA) of 20/80 or better in the same eye as Inclusion Criteria #2a and #2b.
- Presence of all of the following at Baseline:
- Loss on a reliable LPFT of ≥ 8 points in the top 2 rows (LPFT Eligibility Score) in the same eye as Inclusion Criterion #2a; subjects must see at least 9 total points in the top 4 rows (LPFT Total Score).
- 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
- Marginal Reflex Distance (MRD), the distance from the central pupillary light reflex to the central margin of the upper lid, must be ≤ 2 mm (no visible central pupillary light reflex defaults to 0) in the same eye as Inclusion Criterion #2a;
- AND
- Snellen VA of 20/80 or better in the same eye as Inclusion Criteria #2a and #2b.
- 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.
Who cannot join
- 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.
Show all 30Show fewer
- 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.
- Topical application of bimatoprost (ie, Latisse®) to the eyelashes within 7 days prior to Visit 1 and during the study.
- Use of topical ophthalmic medications (including anti-allergy [eg, antihistamines], dry eye [ie, Restasis®] and anti-inflammatory drugs [including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids] other than the assigned study medication within 7 days prior to Visit 1 and during the study. Topical ophthalmic prostaglandin analogues for the treatment of elevated intraocular pressure are permitted if dosed in the evening in accordance with the approved prescribing information. All other topical antiglaucoma medications are prohibited
- Intravitreal injections (eg, Lucentis®, Eylea®, Avastin®, Triesence®) within 7 days prior to Visit 1 and during the study.
- Current punctal plugs or placement of punctal plugs during the study.
- Use of over the counter (OTC) vasoconstrictor/decongestant eye medication (eg, Visine® L.R.®) or any ophthalmic or non-ophthalmic α adrenergic agonist including OTC products (eg, Afrin®) at any time during the study; nonpreserved artificial tears are allowed.
- General
- Resting heart rate (HR) outside the normal range (60-100 beats per minute).
- Hypertension with resting diastolic blood pressure (BP) > 105 mm Hg.
- Use of monoamine oxidase inhibitors (MAOIs; eg, isocarboxazid, phenelzine, tranylcypromine) within 14 days prior to Visit 1 and during the study.
- Advanced arteriosclerotic disease or history of cerebrovascular accident (CVA).
- History of hyperthyroidism or thyroid eye disease (ie, exophthalmos, upper eyelid retraction, diplopia secondary to extraocular muscle involvement). Hypothyroidism that is controlled on medication is allowed.
- Patients with diabetic retinopathy may not be enrolled. However, patients with insulin dependent diabetes, diabetes requiring oral hypoglycemic drugs, or diet controlled diabetes are allowed.
- Pregnancy or lactation.
- Diagnosed benign prostatic hypertrophy requiring medicinal therapy; previous prostatectomy is allowed.
- History of contact or systemic allergic reaction to oxymetazoline or other sympathomimetic drugs (eg, phenylephrine, pseudoephedrine, ephedrine, phenylpropanolamine, fepradinol, or methoxamine).
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Study site
Artesia, California, 90701
Study site
Fort Myers, Florida, 33901
Study site
Kingston, Pennsylvania, 18704
Study site
Largo, Florida, 33773
Study site
Mason, Ohio, 45040
Study site
Nashville, Tennessee, 37215
Study site
Newport Beach, California, 92663
Study site
Pittsburg, Kansas, 66762
Study site
Plantation, Florida, 33324
Study site
Rancho Cordova, California, 95670
Study site
Roswell, Georgia, 30076
Study site
Santa Maria, California, 93454
Study site
Sarasota, Florida, 34239
Study site
Shawnee Mission, Kansas, 66204
About this study
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
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.
Read the detailed description
Ptosis is experienced by approximately 12% of adults over the age of 50 . It is a unilateral or bilateral abnormal drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscle(s) that elevate the upper eyelid: the levator palpebrae superioris and/or Müller's muscle.
Treatment for acquired ptosis usually involves surgery, with risks of infection, bleeding, over or undercorrection, reduced vision, and lagophthalmos (inability to close the eyelids completely) or mechanical treatment e.g scleral contact lenses with a bar to lift the eyelid, eyelid ptosis crutches attached to glasses, or adhesive tape or putty to affix the upper eyelid to the supraorbital structures.
RVL-201 ophthalmic solution is being developed to provide a reversible pharmacologic option for patients with acquired ptosis who are not candidates for surgery or do not wish to undergo surgery.
The objective of this study is to evaluate the safety and efficacy of RVL-1201 ophthalmic solution in the treatment of acquired blepharoptosis and to assess the safety and comfort of RVL-1201 ophthalmic solution for an extended dosing period of 6 weeks. Subjects will be randomized (2:1) to one of 2 treatment arms and treated for 42 days:
- RVL-1201 0.1% one full drop in each eye QD in the morning (N = 100)
- RVL-1201 vehicle (placebo) 1 full drop per eye QD in the morning (N = 50)
Efficacy will be assessed with the LPFT, a validated visual field test using the HVF Analyzer and photographic measurement of MRD (the distance from the pupillary light reflex to the central margin of the upper lid) and PFD (the distance from the upper lid margin to the lower lid margin through the central visual axis). Safety assessment will include bilateral SLE/CFS, measurement of PD from external photographs, dilated ophthalmoscopy/fundus examination, tonometry, Snellen VA using recent correction, vital signs (BP/HR), and collection of adverse events (AEs).
- Conditions
- Acquired Blepharoptosis
- Being tested
- RVL-1201, RVL-1201 Vehicle Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVL-1201Drug
Also called Oxymetazoline Hydrochloride Ophthalmic Solution 0.1%
RVL-1201 Ophthalmic Solution 0.1%
RVL-1201 Vehicle PlaceboDrug
Also called RVL-1201 Ophthalmic Solution 0.1% Placebo
RVL-1201 Vehicle Placebo
| Study group | Role | What they receive |
|---|---|---|
| RVL-1201 | Experimental | RVL-1201 Ophthalmic Solution 0.1% 1 drop per eye QD for 6 weeks Receives: Drug: RVL-1201 |
| RVL-1201 Vehicle Placebo | Placebo comparator | RVL-1201 Ophthalmic Solution vehicle (placebo) 1 drop per eye QD for 6 weeks Receives: Drug: RVL-1201 Vehicle Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: Baseline Day 1 (Hour 0) and Day 1, Day 14, and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016
- Study completionNov 2016
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 Acquired 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- RVL Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chuck Slonim, MD, Principal investigator, Oculos Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436759
- Sponsor's protocol ID
- RVL-1201-201
- Status last verified
- Oct 2021
- First submitted
- 4 May 2015
- Last updated
- 28 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. 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 and Efficacy of RVL-1201 in the Treatment of Acquired Blepharoptosis
- ClinicalTrials.gov ID
- NCT02436759
- Acronym / sponsor ID
- RVL-1201-201
- Conditions
- Acquired Blepharoptosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- RVL Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ptosis is experienced by approximately 12% of adults over the age of 50 . It is a unilateral or bilateral abnormal drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscle(s) that elevate the upper eyelid: the levator palpebrae superioris and/or Müller's muscle.
Treatment for acquired ptosis usually involves surgery, with risks of infection, bleeding, over or undercorrection, reduced vision, and lagophthalmos (inability to close the eyelids completely) or mechanical treatment e.g scleral contact lenses with a bar to lift the eyelid, eyelid ptosis crutches attached to glasses, or adhesive tape or putty to affix the upper eyelid to the supraorbital structures.
RVL-201 ophthalmic solution is being developed to provide a reversible pharmacologic option for patients with acquired ptosis who are not candidates for surgery or do not wish to undergo surgery.
The objective of this study is to evaluate the safety and efficacy of RVL-1201 ophthalmic solution in the treatment of acquired blepharoptosis and to assess the safety and comfort of RVL-1201 ophthalmic solution for an extended dosing period of 6 weeks. Subjects will be randomized (2:1) to one of 2 treatment arms and treated for 42 days:
- RVL-1201 0.1% one full drop in each eye QD in the morning (N = 100)
- RVL-1201 vehicle (placebo) 1 full drop per eye QD in the morning (N = 50)
Efficacy will be assessed with the LPFT, a validated visual field test using the HVF Analyzer and photographic measurement of MRD (the distance from the pupillary light reflex to the central margin of the upper lid) and PFD (the distance from the upper lid margin to the lower lid margin through the central visual axis). Safety assessment will include bilateral SLE/CFS, measurement of PD from external photographs, dilated ophthalmoscopy/fundus examination, tonometry, Snellen VA using recent correction, vital signs (BP/HR), and collection of adverse events (AEs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RVL-1201 | Experimental | Drug: RVL-1201RVL-1201 Ophthalmic Solution 0.1% 1 drop per eye QD for 6 weeks |
| RVL-1201 Vehicle Placebo | Placebo comparator | Drug: RVL-1201 Vehicle PlaceboRVL-1201 Ophthalmic Solution vehicle (placebo) 1 drop per eye QD for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female subjects 18 years of age and older.
- Presence of all of the following at Screening :
- AND
- Presence of all of the following at Baseline:
- AND
Key exclusion criteria (30 listed)
- In either eye
- Congenital ptosis.
- Presence of either of the following:
- Horner syndrome.
- Marcus Gunn jaw winking syndrome.
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-1201Also: Oxymetazoline Hydrochloride Ophthalmic Solution 0.1%RVL-1201 Ophthalmic Solution 0.1% | Drug | RVL-1201 |
| RVL-1201 Vehicle PlaceboAlso: RVL-1201 Ophthalmic Solution 0.1% PlaceboRVL-1201 Vehicle Placebo | Drug | RVL-1201 Vehicle Placebo |
Primary outcome
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).
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- 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.
Chuck Slonim, MD principal investigator
Oculos Clinical Research
14 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 Acquired Blepharoptosis, run by RVL Pharmaceuticals, Inc. at 14 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 18 inclusion and 30 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 20 Oct 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 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). 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 28 Oct 2021.