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Study of SHP639 Eye Drops in Adults With High Eye Pressure or Primary Open-angle Glaucoma

A Randomized, Double-masked, Placebo-controlled Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Daily and Multiple Daily Ascending Doses of SHP639 Topical Ophthalmic Solution in Subjects With Ocular Hypertension or Primary Open-angle Glaucoma (POAG)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03131167
Enrollment
63
Registered
2017-04-27
Start date
2017-05-10
Completion date
2018-05-30
Last updated
2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ocular Hypertension, Primary Open-angle Glaucoma (POAG)

Brief summary

Safety and tolerability of three different concentrations (0.1%, 03%, 0.6%) of the investigational SHP639 eye drops will be evaluated in participants with high eye pressure or primary open-angle glaucoma.

Interventions

DRUGSHP639 (n=60)

Drug SHP639 is a 9-amino acid, synthetic, C-type natriuretic peptide (CNP) analog.

DRUGPlacebo Comparator (n=24)

Drug: Vehicle Ophthalmic placebo solution of the same composition as the test product.

Sponsors

Shire
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Participants must provide written, signed and dated informed consent to participate in the study in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6(R1) and applicable regulations, before completing any study-related procedures. 2. Participants must be aged from 18 through 90 at the time of consent. This inclusion criterion will only be assessed at the screening visit. 3. Participants must have ocular hypertension (OHT) or stable early primary open-angle glaucoma (POAG) in both eyes with acceptable Humphrey visual fields (HVF). Early POAG for this protocol is defined as healthy appearing anterior chamber angles (Shaffer classification system grade 3 or 4) and focal and/or generalized thinning of the optic disc rim characteristic of glaucomatous disease. An acceptable HVF must have been performed within approximately one year of screening, have a false-positive rate of 25 percent (%) maximum, false-negative rate of 25% maximum, and fixation loss rate of 33% maximum, and mean deviation of no worse than -6.00 decibels (dB). 4. On Day -1, participants must have a mean IOP of greater than or equal to (\>=) 24 millimeter of mercury (mmHg) at 8:00 AM and a mean IOP of \>= 22 mmHg at 10:00 AM in at least 1 eye, with an IOP difference of less than (\<) 4 mmHg between eyes at both of these time points. If only 1 eye meets this criterion, then it will be the designated study eye for pharmacodynamic analysis; this eye will also be used for dosing in Cohort A single-dose treatment period (SDTP). 5. Participants must have a best-corrected visual acuity (BCVA) in both eyes of 65 letters on the Early Treatment Diabetic Retinopathy Study chart (Snellen equivalent approximately \[∼\] 20/60) or better at the screening and baseline assessments. 6. Participants must be males or females who are non-pregnant and non-lactating at screening (negative serum beta-human chorionic gonadotropin \[beta-hCG\]); if sexually active during the study, they must agree to comply with the applicable contraceptive requirements throughout the study period and for 60 days following the last dose of investigational product. 7. Participants must have a satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, and clinical and laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the investigator. 8. Participants must understand and be able, willing, and likely to fully comply with study procedures and restrictions. 9. Participants must be non-smokers or have had stable use of tobacco or nicotine-containing products for a 3-month period before signing the informed consent form (ICF). 10. Participants who drink alcohol must have had stable use of alcohol for a 3-month period before signing the ICF.

Exclusion criteria

1. Participant has an anatomically narrow angle, synechiae or evidence of prior inflammation, angle closure glaucoma, normal tension glaucoma, pseudoexfoliation syndrome or pigmentary dispersion syndrome with or without glaucoma, or secondary glaucoma. 2. Participant has corneal endothelial cell counts of less than 2000 cells per millimeter\^2 (measured by noncontact specular microscopy) at the screening or baseline assessments. 3. Participant has central corneal thickness less than 500 micrometer (mcm) or greater than 620 mcm at the screening or baseline assessments. 4. Participant has IOP greater than 32 mmHg in either eye before randomization. 5. Participant has used topical ocular hypotensive medications as follows: prostaglandin analogs, beta-adrenoceptor antagonists, alpha-adrenergic agonists, or epinephrine-related medications within 4 weeks before the first dose of investigational product; or pilocarpine or carbonic anhydrase inhibitors within 7 days before the first dose of investigational product. 6. Participant has a history of angle closure, ocular surgery, microinvasive glaucoma surgery device insertion, or laser surgery, except for the following procedures, which are allowed: uncomplicated cataract surgery, laser peripheral iridotomy with resultant angle of Shaffer grade 3 or 4, and postcataract neodymium-doped yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy. Cataract surgery and other procedures must have occurred a minimum of 3 months before randomization. 7. Participant has a history of significant ocular trauma or ocular disease including but not limited to moderate to severe dry eye disease that requires chronic treatment or punctal plugs. 8. Participant has evidence of ocular infection, inflammation, degeneration, or dystrophy at the screening or baseline assessments, including but not limited to moderate to severe blepharitis (mild blepharitis is allowed), conjunctivitis (allergic or infectious), corneal dystrophy (epithelial, stromal, or endothelial), corneal haze of grade 1 or greater based on the Hwang Grading Scale of Corneal Haze, corneal opacities, keratitis, uveitis, or vitritis. 9. Participant has retinal disease including but not limited to: moderate or severe non-proliferative diabetic retinopathy (NPDR) (early NPDR is allowed), proliferative diabetic retinopathy, intermediate or advanced dry age-related macular degeneration (AMD) (early dry AMD is allowed), all geographic atrophy, or all wet AMD. 10. Participant has any non-glaucomatous optic neuropathy or other significant non-glaucomatous ocular disease that is likely to affect visual function. 11. Participant has any corneal or ocular surface pathology in either eye that prevents proper IOP measurement, pachymetry, or other study data collection procedures. 12. Participant has had changes to their existing prescription medication regimen for chronic disease, including those medicines that affect IOP, within 14 days or 5 half-lives before screening, whichever is longer. 13. Participant has started any new prescription drug medication for chronic disease, including those medicines that affect IOP, within 14 days or 5 half-lives before screening, whichever is longer. 14. Participant has a history of corticosteroid use within 3 months before randomization, except for non-periocular dermatologic use, which is allowed. 15. Participant has used belladonna alkaloids (scopolamine, hyoscamine, atropine) within 7 days prior to randomization, cannabinoids or opioids within 28 days before randomization, or B-type natriuretic peptides within the past year before randomization; or a participant has an anticipated need for any of the aforementioned drugs/drug categories during the study. 16. Participant has used amantadine within 28 days before randomization. 17. Participant is unable to discontinue contact lens use during and for 60 minutes following instillation of study medication, during ophthalmologic examinations, and during study visits. 18. Participant has a current or relevant history of any physical, medical, mental, or psychiatric illness, disorder, or condition that may require treatment during the study and/or that may interfere with the participant complying with the study rules and procedures or completing the study. 19. Participant has any condition that presents undue risk from use of the investigational product, assessment tools, or procedures. 20. Participant is a woman who is pregnant (positive serum beta-hCG pregnancy test at the time of screening), lactating, or less than 90 days post-partum at randomization. 21. Participant has donated blood within 60 days before first dose of investigational product. 22. Participant has donated plasma within 28 days before first dose of investigational product. 23. Participant has used another investigational product within 30 days before the first dose of investigational product or is actively enrolled in a drug or vaccine clinical study. 24. Participant has a positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies screen. 25. Participant has a positive drugs of abuse screen or alcohol breathalyzer test. 26. Participant has been previously enrolled in this study. 27. Participant has known hypersensitivity or allergy to any of the ingredients of the investigational product. 28. Participant consumes more than 21 units of alcohol per week or is unable to refrain from alcohol consumption within 48 hours before a scheduled visit. (1 alcohol unit=1 beer or 1 wine \[5 ounce per 150 milliliter\] or 1 liquor \[1.5 ounce per 40 milliliter\] or 0.75 ounce alcohol.) 29. Participant is unable to refrain from tobacco or any products containing nicotine within 8 hours before a scheduled visit.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Treatment Emergent Adverse Event (TEAE)From start of study drug administration up to follow-up (Day 88)An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose.

Secondary

MeasureTime frameDescription
Change From Baseline in Intra Ocular Pressure (IOP) at Day 29Baseline, Day 29IOP was measured using Goldmann applanation tonometry and reported data from baseline at day 29 for both study eye and non study eye.

Countries

United States

Participant flow

Recruitment details

The study was conducted at 4 study centers in the United States between 10 May 2017 (first participant first visit) and 30 May 2018 (last participant last visit).

Pre-assignment details

Totally, 63 participants enrolled, randomized and received treatment in two parts of the study with one cohort for one dose level (Part 1: Cohort A1, A2, A3, with single dose and QD multiple dose, followed by Cohort B1, B2, B3 with BID multiple dose. Part 2: Cohort C1, C2, C3 with TID multiple dose, followed by D1, D2, D3 with QID multiple dose).

Participants by arm

ArmCount
Placebo QD
Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye once daily (QD) during the once daily dose regimen.
6
SHP639 0.1% QD
Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
5
SHP639 0.3% QD
Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
5
SHP639 0.6% QD
Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye once daily (QD) during the once daily dose regimen.
5
Placebo BID
Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
6
SHP639 0.1% BID
Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
5
SHP639 0.3% BID
Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
5
SHP639 0.6% BID
Participants received one drop of SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the twice daily dose regimen.
5
Placebo Repeated BID
Participants received one drop of placebo matched to SHP639 at a dose of 0.6% applied topically in the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.
2
SHP639 0.6% Repeated BID
Participants received one drop of SHP639 at a dose of 0.6% applied topically in both the designated eye and non study eye twice daily (BID) during the repeated twice daily dose regimen.
5
Placebo TID
Participants received one drop of placebo matched to SHP639 at a dose of 0.1%, 0.3%, 0.6% respectively applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
4
SHP639 0.1% TID
Participants received one drop of SHP639 at a dose of 0.1% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
5
SHP639 0.3% TID
Participants received one drop of SHP639 at a dose of 0.3% applied topically in the designated eye and non study eye thrice daily (TID) during the thrice daily dose regimen.
5
Total63

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012
Overall StudyOther (Unspecified)0000010000000

Baseline characteristics

CharacteristicPlacebo QDSHP639 0.1% QDSHP639 0.3% QDSHP639 0.6% QDPlacebo BIDSHP639 0.1% BIDSHP639 0.3% BIDSHP639 0.6% BIDPlacebo Repeated BIDSHP639 0.6% Repeated BIDPlacebo TIDSHP639 0.1% TIDSHP639 0.3% TIDTotal
Age, Continuous64.0 Years
STANDARD_DEVIATION 7.77
63.8 Years
STANDARD_DEVIATION 7.46
67.6 Years
STANDARD_DEVIATION 6.39
59.0 Years
STANDARD_DEVIATION 2.74
68.7 Years
STANDARD_DEVIATION 8.19
72.8 Years
STANDARD_DEVIATION 8.58
69.0 Years
STANDARD_DEVIATION 7.31
68.2 Years
STANDARD_DEVIATION 6.69
70.0 Years
STANDARD_DEVIATION 4.24
74.6 Years
STANDARD_DEVIATION 5.18
67.5 Years
STANDARD_DEVIATION 18.38
70.8 Years
STANDARD_DEVIATION 14.04
69.4 Years
STANDARD_DEVIATION 4.93
68.4 Years
STANDARD_DEVIATION 8.81
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants4 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants5 Participants5 Participants5 Participants5 Participants5 Participants4 Participants5 Participants2 Participants5 Participants3 Participants5 Participants1 Participants56 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
4 Participants5 Participants1 Participants5 Participants2 Participants0 Participants5 Participants2 Participants0 Participants0 Participants0 Participants0 Participants0 Participants24 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
2 Participants0 Participants3 Participants0 Participants4 Participants4 Participants0 Participants3 Participants2 Participants5 Participants4 Participants5 Participants5 Participants37 Participants
Sex: Female, Male
Female
4 Participants4 Participants2 Participants4 Participants5 Participants5 Participants2 Participants4 Participants0 Participants4 Participants2 Participants3 Participants4 Participants43 Participants
Sex: Female, Male
Male
2 Participants1 Participants3 Participants1 Participants1 Participants0 Participants3 Participants1 Participants2 Participants1 Participants2 Participants2 Participants1 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 50 / 50 / 50 / 60 / 50 / 50 / 50 / 20 / 50 / 40 / 50 / 5
other
Total, other adverse events
2 / 60 / 52 / 50 / 52 / 62 / 50 / 55 / 51 / 25 / 52 / 41 / 53 / 5
serious
Total, serious adverse events
0 / 60 / 50 / 50 / 50 / 60 / 50 / 50 / 50 / 20 / 50 / 40 / 50 / 5

Outcome results

Primary

Number of Participants With Treatment Emergent Adverse Event (TEAE)

An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose.

Time frame: From start of study drug administration up to follow-up (Day 88)

Population: Safety set consisted of all participants who were randomized and who received at least 1 dose of investigational product.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Placebo QDNumber of Participants With Treatment Emergent Adverse Event (TEAE)2 Participants
SHP639 0.1% QDNumber of Participants With Treatment Emergent Adverse Event (TEAE)0 Participants
SHP639 0.3% QDNumber of Participants With Treatment Emergent Adverse Event (TEAE)2 Participants
SHP639 0.6% QDNumber of Participants With Treatment Emergent Adverse Event (TEAE)0 Participants
Placebo BIDNumber of Participants With Treatment Emergent Adverse Event (TEAE)2 Participants
SHP639 0.1% BIDNumber of Participants With Treatment Emergent Adverse Event (TEAE)2 Participants
SHP639 0.3% BIDNumber of Participants With Treatment Emergent Adverse Event (TEAE)0 Participants
SHP639 0.6% BIDNumber of Participants With Treatment Emergent Adverse Event (TEAE)5 Participants
Placebo Repeated BIDNumber of Participants With Treatment Emergent Adverse Event (TEAE)1 Participants
SHP639 0.6% Repeated BIDNumber of Participants With Treatment Emergent Adverse Event (TEAE)5 Participants
Placebo TIDNumber of Participants With Treatment Emergent Adverse Event (TEAE)2 Participants
SHP639 0.1% TIDNumber of Participants With Treatment Emergent Adverse Event (TEAE)1 Participants
SHP639 0.3% TIDNumber of Participants With Treatment Emergent Adverse Event (TEAE)3 Participants
Secondary

Change From Baseline in Intra Ocular Pressure (IOP) at Day 29

IOP was measured using Goldmann applanation tonometry and reported data from baseline at day 29 for both study eye and non study eye.

Time frame: Baseline, Day 29

Population: Pharmacodynamic (PD) set consisted of all participants in the safety set for whom the primary PD data were evaluable.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo QDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye0.00 millimeter of mercury (mmHg)Standard Deviation 1.294
Placebo QDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye-0.38 millimeter of mercury (mmHg)Standard Deviation 1.43
SHP639 0.1% QDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye-1.20 millimeter of mercury (mmHg)Standard Deviation 1.605
SHP639 0.1% QDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye-1.50 millimeter of mercury (mmHg)Standard Deviation 0.354
SHP639 0.3% QDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye0.45 millimeter of mercury (mmHg)Standard Deviation 1.515
SHP639 0.3% QDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye1.20 millimeter of mercury (mmHg)Standard Deviation 2.087
SHP639 0.6% QDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye0.40 millimeter of mercury (mmHg)Standard Deviation 1.084
SHP639 0.6% QDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye0.70 millimeter of mercury (mmHg)Standard Deviation 0.908
Placebo BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye0.83 millimeter of mercury (mmHg)Standard Deviation 1.393
Placebo BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye0.38 millimeter of mercury (mmHg)Standard Deviation 1.539
SHP639 0.1% BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye0.50 millimeter of mercury (mmHg)Standard Deviation 1.061
SHP639 0.1% BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye0.44 millimeter of mercury (mmHg)Standard Deviation 1.972
SHP639 0.3% BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye-0.20 millimeter of mercury (mmHg)Standard Deviation 0.837
SHP639 0.3% BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye-0.20 millimeter of mercury (mmHg)Standard Deviation 0.758
SHP639 0.6% BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye-0.40 millimeter of mercury (mmHg)Standard Deviation 2.826
SHP639 0.6% BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye-0.25 millimeter of mercury (mmHg)Standard Deviation 2.61
Placebo Repeated BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye-0.13 millimeter of mercury (mmHg)Standard Deviation 2.652
Placebo Repeated BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye-1.00 millimeter of mercury (mmHg)Standard Deviation 4.243
SHP639 0.6% Repeated BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye-1.80 millimeter of mercury (mmHg)Standard Deviation 2.26
SHP639 0.6% Repeated BIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye-2.00 millimeter of mercury (mmHg)Standard Deviation 1.49
Placebo TIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye0.00 millimeter of mercury (mmHg)Standard Deviation 3.889
Placebo TIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye-1.13 millimeter of mercury (mmHg)Standard Deviation 4.539
SHP639 0.1% TIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye0.10 millimeter of mercury (mmHg)Standard Deviation 0.929
SHP639 0.1% TIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye-0.10 millimeter of mercury (mmHg)Standard Deviation 1.421
SHP639 0.3% TIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Non-Study Eye-3.85 millimeter of mercury (mmHg)Standard Deviation 2.389
SHP639 0.3% TIDChange From Baseline in Intra Ocular Pressure (IOP) at Day 29Study Eye-4.65 millimeter of mercury (mmHg)Standard Deviation 3.17

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026