Acquired BlepharophimosisPhase 3NCT06514612
LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis.
A Phase 3 study testing STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers in people with Acquired Blepharophimosis, run by Santen SAS at 36 sites in 9 countries.
Trial summary
A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acquired Blepharophimosis
- What is being tested?
- STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 36 sitesin 9 countries
- Study dates
- 30 Dec 2024to 1 Aug 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and sign an informed consent form prior to participation in any studyrelated procedures.
- Male or female subjects ≥ 18 years and ≤ 75 years.
- Presence of all the following at Screening:
- diagnosis of acquired ptosis in both eyes with MRD 1 ≥0 and ≤ 2 mm in the study eye
- Snellen VA of 20/80 or better in both eyes Note: MRD1 is defined as the distance between upper eye lid margin and centre of the pupil. MRD0 is defined as the upper eye lid margin at the centre of the pupil. Measurement of MRD1 will be done by a Central Reading Centre. If the centre of the pupil cannot be determined by the Central Reading Centre due to negative MRD1, the subject will be deemed ineligible.
- Females who are 1-year postmenopausal, surgically sterilised, or females of childbearing potential with a negative urine pregnancy test at screening (Visit 1). Females 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.
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- A male subject with a female partner of childbearing potential should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery at least 6 months prior to signing the study ICF and beginning screening), or other contraception deemed adequate by the investigator during the study.
- Able to self-administer study treatment or to have the study treatment administered by a caregiver throughout the study period.
- An answer of 'Yes' to the question 'Does the ptosis cause enough burden to the subject to want to receive treatment for it'.
- Loss of ≥ 8 points not seen at or above 10° from fixation in the superior visual field of a reliable HVF 36-point ptosis protocol test at screening visit in the same eye with MRD1 ≥0 and ≤ 2 mm. If both eyes have MRD1 ≥0 and ≤ 2 mm the more ptotic eye (the eye with the smaller MRD1 measurement) will be the study eye. If the MRD1 is the same in both eyes, the eye with the worse VF will be the study eye. If the MRD1 and VF is the same in both eyes, the right eye will be the study eye. The HVF Analyzer will determine if the visual field test is reliable. If the HVF Analyzer issues an "XX" for fixation losses, false positives, and/or false negatives, the test will be deemed unreliable. If deemed unreliable, the test must be retaken once per scheduled screening visit. If a reliable visual field cannot be obtained, the subject will be a screen failure.
Who cannot join
- In either eye:
- Congenital ptosis.
- Presence of either of the following:
- Pseudo ptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin); or
- Dermatochalasis that extends less than 3 mm above the upper eyelid margin.
- Neurogenic ptosis (e.g., Horner's syndrome, 3rd cranial nerve palsy).
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- Myogenic ptosis.
- Marcus Gunn jaw-winking syndrome.
- Previous ptosis surgery (previous blepharoplasty is allowed provided the surgery took place at least 3 months prior to screening [Visit 1]).
- Lid position affected by lid or conjunctival scarring.
- Visual field loss from any cause other than ptosis.
- History of herpes keratitis.
- Poor fixation or abnormal eye position which prevents from taking reliable pictures for MRD1 measurement.
- History of closed/narrow angle glaucoma (unless patent peripheral iridotomy has been performed at least 3 months prior to screening (Visit 1).
- Facial including periocular neurotoxin (e.g., Botox, Xeomin, Dysport, Myobloc) injections within 3 months prior to screening (Visit 1) and during the study.
- Topical application of bimatoprost (i.e., Latisse®) to the eyelashes within 8 days prior to screening (Visit 1) and during the study.
- Mechanical ptosis e.g., ptosis due to orbital, corneal or lid tumor, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
- Use of topical ophthalmic medications including anti-allergy [e.g., antihistamines], dry eye medications [e.g., IKERVIS®] (except artificial tears with anticipated stable usage during the study), antimicrobial drugs [e.g., antibiotics and antivirals], and anti-inflammatory drugs [including nonsteroidal anti-inflammatory drugs (NSAIDs) and steroids] within 8 days prior to screening (Visit 1) and during the study. Timolol maleate, or sympathetic alpha receptor agonists (e.g., brimonidine tartrate, or apraclonidine hydrochloride) for the treatment of elevated intraocular pressure. Please note that 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.
- Any intravitreal injections (e.g., antiVEGFs, steroids) within 8 days prior to screening (Visit
- 1) and during the study.
- Current punctal plugs or placement of punctal plugs during the study.
- Current use of OTC vasoconstrictor/decongestant eye medication (e.g., Visine® L.R.®) or any ophthalmic or non-ophthalmic α-adrenergic agonist including OTC products (e.g., Afrin®) at any time during the study, (artificial tears are allowed).
- Monoamine oxidase inhibitors (MAOI) (e.g., selegiline hydrochloride, rasagiline mesilate, safinamide mesilate).
Trial locations and contacts
36 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
36 sites in 9 countries
Spain7 sites, 7 recruiting
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, 18014
Dr Santiago Ortiz Pérez
- Recruiting
Virgen de las Nieves University Hospital
Granada, 18014
Dr Santiago Ortiz-Perez
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, 28034
Dr Marco Sales Sanz
- Recruiting
Hospital Universitario Ramón y Caja
Madrid, 28034
Dr Marco Sanz
- Recruiting
Complexo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706
Dr José Manuel Abalo Lojo
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Dr Laura Gil Arribas
- Recruiting
Miguel Servet University Hospital
Zaragoza, 50009
Dr Laura Gil Arribas
United Kingdom6 sites, 6 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds, LS9 7TF
Prof. Bernard Chang
- Recruiting
Moorfields Eye Hospital NHS Foundation Trust - Moorfields Eye Hospital
London, EC1V 2PD
Dr. Daniel Ezra
- Recruiting
FaceRestoration Ltd
London, W1G 8QL
Dr Rachna Murthy
- Recruiting
Opal Clinic London Ltd
London, W8 5JN
Dr Nikhil Cascone
- Recruiting
South tyneside & Sunderland NHS Trust, Sunderland Eye Infirmary
Sunderland, SR2 9HP
Mrs Adriana
- Recruiting
South Tyneside and Sunderland NHS Foundation Trust, Sunderland Eye Infirmary
Sunderland
Dr. Adriana Chilinska
Hungary5 sites, 5 recruiting
- Recruiting
Budapest Retina Associates
Budapest
Dr. Seres András
- Recruiting
Budapesti Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
Budapest
Dr. Czumbel Norbert
- Recruiting
Észak-Pesti Centrumkórház - Honvédkórház
Budapest
Dr Gábor Vogt
- Recruiting
Debreceni Egyetem Klinikai Központ
Debrecen
Dr. Vajas Attila
- Recruiting
Ganglion Orvosi Központ - Nozologen Kft.
Pécs
Dr. Varsányi Balázs
France4 sites, 4 recruiting
- Recruiting
Clinique Ophtalmologique Thiers
Bordeaux, 33100
Dr Olivier Galatoire
- Recruiting
CHU Rennes - PONTCHAILLOU Service ophtalmologie
Guillon, 35000
Prof. Frédéric Mouriaux
- Recruiting
Hôpital Fondation Adolphe de Rothschild
Paris, 75019
Dr Marie Callet
- Recruiting
CHU de Saint Etienne - Hôpital NORD Service d'Ophtalmologie
Saint-Etienne, 42055
Prof. Philippe Gain
Poland4 sites, 4 recruiting
- Recruiting
Profesorskie Centrum Okulistyki OKULISTYKA OPTIMUM
Gdansk
Dr Krystyna Raczynska
- Recruiting
Gabinet Okulistyczny Prof. Edward Wylegala
Katowice, 40-594
Dr Adam Wylegala
- Recruiting
Centralny Szpital Kliniczny MSWiA w Warszawie, Oddzial Okulistyki
Warsaw, 02-507
Dr Larysa Krajewska-Weglewicz
- Recruiting
Military Institute of Medecine - National Institute of Research
Warsaw, 04-141
Dr Izabela Nowak-Gospodarowicz
Czechia3 sites, 3 recruiting
- Recruiting
Oftex.s.r.o, oční klinika
Pardubice, 530 02
Dr Vladimir Korda
- Recruiting
Fakultni nemocnice Plzeň, Oční oddělení
Pilsen
Dr Štěpán Rusňák
- Recruiting
Fakultni Thomayerova nemocnice
Prague, 140 59
Dr Katerina Myslik Manethova
Italy3 sites, 3 recruiting
- Recruiting
AOU di Ferrara, Arcispedale Sant'Anna
Ferrara, 44124
Dr Mura Marco
- Recruiting
AOU Federico II
Naples, 80131
Dr Strianese Diego
- Recruiting
PU A. Gemelli, Università Cattolica del Sacro Cuore
Roma, 00168
Dr Savino Gustavo
Germany2 sites, 2 recruiting
- Recruiting
Unversitaetsmedizin Goettingen
Goettigen, 37075
Dr Michael Schittkowski
- Recruiting
Universitätsmedizin Göttingen; Georg-August-Universität
Göttingen, 37075
Prof. Dr. Michael Schittkowski
Netherlands2 sites, 2 recruiting
- Recruiting
Leiden University Center (LUMC)
Leiden, 2333 ZA
Dr Stijn Van der Meeren
- Recruiting
Oogziekenhuis Rotterdam
Rotterdam, 3011 BH
Dr Dion Paridaens
About this study
Official title: A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) Used Twice Daily (BID) in the Treatment of Acquired Blepharoptosis
A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis
Read the detailed description
This is a randomised, double-masked, placebo-controlled Phase 3 study of the safety and efficacy of STN1013800 in the treatment of acquired blepharoptosis.
Subjects diagnosed with acquired blepharoptosis who meet eligibility criteria at Visit 1 (Screening) will return within 8 days for Visit 2 (Baseline, Day 1). At Visit 2 (Baseline, Day 1) they will be randomised to receive double-masked treatment for 6 weeks, with study visits completed at Week 2 (Day 14) and Week 6 (Day 42), and a post-treatment visit completed 2 weeks (± 3 days) after last study drug administration. Approximately 234 adult subjects with blepharoptosis who meet all the eligibility criteria will be randomised in a 1:1 ratio to receive:
- STN1013800 BID
- Placebo BID
Note that:
- On study visits Day 1 and Day 42, the AM dose is administered at 08:00 (at site) and the PM dose is administered at 16:00 (self-administered at home)
- On study visit Day 14, the AM dose is administered at 06:00 (self-administered at home), the PM dose is administered at 14:00 (at site)
- Conditions
- Acquired Blepharophimosis
- Being tested
- STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers, Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containersDrug
STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers
Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containersOther
Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers
| Study group | Role | What they receive |
|---|---|---|
| STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers | Experimental | Not described Receives: Drug: STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers |
| Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers | Placebo comparator | Not described Receives: Other: Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Marginal Reflex Distance (MRD1) on Day 14 at 4 hours after PM dose.
Change from baseline in MRD1 (Marginal Reflex Distance, Distance from the centre of the pupil to central upper lid margin) on Day 14 at 4 hours after PM dose. This is to evaluate the efficacy of STN1013800 dosed twice daily in the treatment of acquired blepharoptosis on Day 14
Measured: Day 14 at 4 hours
Secondary outcomes (1)
PRO (Patient Reported Outcome): PGIC (Subject Global Impression of Change) on Day 14, 4 hours after PM dose
To assess the degree of improvement experienced by subjects since start of the trial (PRO)
Measured: Day 14 at 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start30 Dec 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired BlepharophimosisStudies 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
- Model description
- Subjects diagnosed with acquired blepharoptosis who meet eligibility criteria at Visit 1 (Screening) will return within 8 days for Visit 2 (Baseline, Day 1). At Visit 2 (Baseline, Day 1) they will be randomised to receive double-masked treatment for 6 weeks, with study visits completed at Week 2 (Day 14) and Week 6 (Day 42), and a post-treatment visit completed 2 weeks (± 3 days) after last study drug administration. This study will consist of a screening period of up to 8 days, a 6-week double-masked treatment period, and a post-treatment visit 2 weeks after the last administration of the study drug.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514612
- Sponsor's protocol ID
- 101380003SA
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2024
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) Used Twice Daily (BID) in the Treatment of Acquired Blepharoptosis
- ClinicalTrials.gov ID
- NCT06514612
- Acronym / sponsor ID
- 101380003SA
- Conditions
- Acquired Blepharophimosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Santen SASIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis
Detailed description
This is a randomised, double-masked, placebo-controlled Phase 3 study of the safety and efficacy of STN1013800 in the treatment of acquired blepharoptosis.
Subjects diagnosed with acquired blepharoptosis who meet eligibility criteria at Visit 1 (Screening) will return within 8 days for Visit 2 (Baseline, Day 1). At Visit 2 (Baseline, Day 1) they will be randomised to receive double-masked treatment for 6 weeks, with study visits completed at Week 2 (Day 14) and Week 6 (Day 42), and a post-treatment visit completed 2 weeks (± 3 days) after last study drug administration. Approximately 234 adult subjects with blepharoptosis who meet all the eligibility criteria will be randomised in a 1:1 ratio to receive:
- STN1013800 BID
- Placebo BID
Note that:
- On study visits Day 1 and Day 42, the AM dose is administered at 08:00 (at site) and the PM dose is administered at 16:00 (self-administered at home)
- On study visit Day 14, the AM dose is administered at 06:00 (self-administered at home), the PM dose is administered at 14:00 (at site)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Subjects diagnosed with acquired blepharoptosis who meet eligibility criteria at Visit 1 (Screening) will return within 8 days for Visit 2 (Baseline, Day 1). At Visit 2 (Baseline, Day 1) they will be randomised to receive double-masked treatment for 6 weeks, with study visits completed at Week 2 (Day 14) and Week 6 (Day 42), and a post-treatment visit completed 2 weeks (± 3 days) after last study drug administration. This study will consist of a screening period of up to 8 days, a 6-week double-masked treatment period, and a post-treatment visit 2 weeks after the last administration of the study drug.
| Arm | Type | Receives |
|---|---|---|
| STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers | Experimental | Drug: STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers |
| Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers | Placebo comparator | Other: Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to understand and sign an informed consent form prior to participation in any studyrelated procedures.
- Male or female subjects ≥ 18 years and ≤ 75 years.
- Presence of all the following at Screening:
- Females who are 1-year postmenopausal, surgically sterilised, or females of childbearing potential with a negative urine pregnancy test at screening (Visit 1). Females 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.
- A male subject with a female partner of childbearing potential should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery at least 6 months prior to signing the study ICF and beginning screening), or other contraception deemed adequate by the investigator during the study.
Key exclusion criteria (23 listed)
- In either eye:
- Congenital ptosis.
- Presence of either of the following:
- Neurogenic ptosis (e.g., Horner's syndrome, 3rd cranial nerve palsy).
- Myogenic ptosis.
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 |
|---|---|---|
| STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containersSTN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers | Drug | STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers |
| Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containersPlacebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers | Other | Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers |
Primary outcome
Change from baseline in Marginal Reflex Distance (MRD1) on Day 14 at 4 hours after PM dose.
Time frame: Day 14 at 4 hours
Change from baseline in MRD1 (Marginal Reflex Distance, Distance from the centre of the pupil to central upper lid margin) on Day 14 at 4 hours after PM dose. This is to evaluate the efficacy of STN1013800 dosed twice daily in the treatment of acquired blepharoptosis on Day 14
1 secondary outcome
PRO (Patient Reported Outcome): PGIC (Subject Global Impression of Change) on Day 14, 4 hours after PM dose
Time frame: Day 14 at 4 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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.
36 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers in people with Acquired Blepharophimosis, run by Santen SAS at 36 sites in 9 countries.
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 10 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Spain, United Kingdom, Hungary, France, Poland and 4 more countries. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Santen SAS Clinical Operations (+31 683 667 357, edith.vandijkman@santen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Marginal Reflex Distance (MRD1) on Day 14 at 4 hours after PM dose. (time frame: Day 14 at 4 hours). 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 4 May 2026.