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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003361-25 | EudraCT Number |
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The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHP640 | Experimental | Participants will instill 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) for 7 days. |
|
| PVP-I 0.6% | Active Comparator | Participants will instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID for 7 days |
|
| Placebo | Placebo Comparator | Participants will instill 1 drop of placebo ophthalmic solution in each eye 4 times QID for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHP640 | Drug | Instill 1 drop of SHP640 (povidone-iodine [PVPI] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5 | Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%. | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5 | Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%. |
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Inclusion Criteria:
An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
Ability to voluntarily provide written, signed, and dated (personally or via a parent(s), guardian, or legally authorized representative(s) informed consent (and assent, if applicable) to participate in the study.
Participants of any age at Visit 1 (Note: participants less than (<) 3 months of age at Visit 1 must have been full-term, that is (ie,) greater than or equal to (>=) 37 weeks gestational age at birth).
Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.
Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye confirmed by the presence of the following minimal clinical signs and symptoms in that same eye:
Be willing to discontinue contact lens wear for the duration of the study.
Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will be assessed by an age appropriate method in accordance with the AAP Policy Statement for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians (Donahue and Baker, 2016; American Academy of Pediatrics, 2016). The policy statement recommends formal vision screening can begin at 3 years of age. VA measurements for children under the age of 3 will be done at the discretion of the investigator. If not done, child should be able to fixate on and follow a moving object, except participants < 2 months of age who have not yet developed this ability. Participants < 2 months will be enrolled at the discretion of investigator.
Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
Exclusion Criteria:
Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigator's discretion.
Current or relevant history of physical or psychiatric illness, any medical disorder that may make the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.
Prior enrollment in a FST-100 or SHP640 clinical study.
Participants who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or planned for the period of the study.
Have a preplanned overnight hospitalization during the period of the study.
Have presence of any intraocular, corneal, or conjunctival ocular inflammation (example [eg,] uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than bacterial conjunctivitis.
Have active or a history of ocular herpes.
Have at enrollment or within <= 30 days of Visit 1, a clinical presentation more consistent with the diagnosis of non-infectious conjunctivitis (except presumed seasonal/perennial allergic conjunctivitis) or non-bacterial ocular infection (eg, viral, fungal, acanthamoebal, or other parasitic). Note: history or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary.
Neonates or infants (ie, participants less than 12 months of age) who have suspected or confirmed (based on the result of any test conducted prior to screening) conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.
Neonates or infants (ie, participants less than 12 months of age) whose birth mothers had any sexually transmitted disease within 1 month of delivery or any history of genital herpes.
Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity, congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic involvement that could affect study variables.
Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma or be a glaucoma suspect.
Have any known clinically significant optic nerve defects.
Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect or any significant corneal opacity at Visit 1.
Presence of significant, active condition in the posterior segment that requires invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor inhibitors or corticosteroids) and may progress during the study participation period.
Have used any topical ocular or systemic antibiotics within <= 7 days of enrollment.
Have used any topical ocular non-steroidal anti-inflammatory drugs within <= 1 day of enrollment.
Have used any topical ophthalmic steroids in the last <= 14 days.
Have used any systemic corticosteroid agents within <= 14 days of Day 1. Stable (initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no anticipated change in dose for the duration of the study. Topical dermal steroids are allowed except in the periocular area.
Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1.
Have used any topical ophthalmic products, including tear substitutes, and over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be unable to discontinue all topical ophthalmic products for the duration of the study. Use of hot or cold compresses is also not permitted during the study.
Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled systemic disease or debilitating disease (eg, cardiovascular disease, hypertension, sexually transmitted diseases/infections, diabetes, or cystic fibrosis) that may affect the study parameters, per investigator's discretion.
Any known history of immunodeficiency disorder or known active conditions predisposing to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence of active hepatitis A (anti-hepatitis A virus immunoglobulin M), or organ or bone marrow transplantation.
Within 30 days prior to the first dose of investigational product:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85225 | United States | ||
| Cornea and Cataract Consultants of Arizona |
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
A total of 1080 participants were screened, of them 753 enrolled and randomized to treatment. One participant was randomized in error and therefore captured only in the intent-to-treat (ITT) population.
Study was conducted at 121 centers in 14 countries between 29 Mar 2017 (first participant first visit) and 01 Oct 2018 (last participant last visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | SHP640 | Participants administered 1 drop of SHP640 (povidone-iodine [PVP-I] 0.6 percent [%] and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times a day (QID) for 7 days. |
| FG001 | PVP-I 0.6% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Protocol | Sep 27, 2016 | Sep 23, 2019 |
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| PVP-I 0.6% | Drug | Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days. |
|
| Placebo | Drug | Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days. |
|
| Baseline, Day 5 |
| Number of Participants With Clinical Resolution | Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. | Day 3, 8 and 12 |
| Number of Participants With Bacterial Eradication | Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. | Day 3, 8 and 12 |
| Bulbar Conjunctival Injection Score | Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. | Day 3, 5, 8 and 12 |
| Change From Baseline in the Bulbar Conjunctival Injection Score | Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. | Baseline, Day 3, 5, 8 and 12 |
| Ocular Conjunctival Discharge Score | Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. | Day 3, 5, 8 and 12 |
| Change From Baseline in the Ocular Conjunctival Discharge Score | Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. | Baseline, Day 3, 5, 8 and 12 |
| Global Clinical Score | Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. | Day 3, 5, 8 and 12 |
| Change From Baseline in the Global Clinical Score | Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. | Baseline, Day 3, 5, 8 and 12 |
| Number of Participants With Modified Clinical Resolution | Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. | Day 3, 5, 8 and 12 |
| Number of Participants With Expanded Clinical Resolution | Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. | Day 3, 5, 8 and 12 |
| Time to Clinical Resolution | Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1. | Baseline to Day 12 |
| Number of Participants Who Used Rescue Medication | Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons. | Baseline to Day 12 |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was 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. Any AE that occured after the first dose of investigational product instillation was considered a TEAE. | From start of study drug administration up to 14 days |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| M&M Eye Institute | Prescott | Arizona | 86301 | United States |
| Schwartz Laser Eye Center | Scottsdale | Arizona | 85260 | United States |
| Walman Eye Center | Sun City | Arizona | 85351 | United States |
| Milton M. Hom, OD, FAAO | Azusa | California | 91702 | United States |
| Clark S Tsai Eye Center | Concord | California | 94520 | United States |
| Lugene Eye Institute Inc | Glendale | California | 91204 | United States |
| Mark B. Kislinger, MD, Inc. | Glendora | California | 91741 | United States |
| Inland Eye Specialists | Hemet | California | 92545 | United States |
| Lakeside Vision Center | Irvine | California | 92604 | United States |
| Hull Eye Center | Lancaster | California | 93534 | United States |
| Eye Physicians of Long Beach | Long Beach | California | 90808 | United States |
| Oxford Optical | Los Angeles | California | 90020 | United States |
| Sok H. Nam, M.D. Inc. | Los Angeles | California | 90020 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| Macy Eye Center | Los Angeles | California | 90048 | United States |
| North Valley Eye Medical Group Inc | Mission Hills | California | 91345 | United States |
| North Bay Eye Associates, Inc. | Petaluma | California | 94954 | United States |
| Arch Health Partners | Poway | California | 92064 | United States |
| Martel Eye Medical Group | Rancho Cordova | California | 95670 | United States |
| Shasta Eye Medical Group, Inc. | Redding | California | 96001 | United States |
| Clinical Trials Research | Roseville | California | 95661 | United States |
| Sacramento Eye Consultants | Sacramento | California | 95815 | United States |
| WCCT Global (PH 1 Unit) | Santa Ana | California | 92705 | United States |
| East West Eye Institute | Torrance | California | 90505 | United States |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Specialty Eye Care | Parker | Colorado | 80134 | United States |
| Danbury Eye Physicians and Surgeons | Danbury | Connecticut | 06810 | United States |
| Ophthalmic Consultants of Connecticut | Meriden | Connecticut | 06824 | United States |
| Windham Eye Group | Willimantic | Connecticut | 06226 | United States |
| The Eye Associates of Manatee, LLP | Bradenton | Florida | 34209 | United States |
| Bruce A. Segal, MD, PA | Delray Beach | Florida | 33484 | United States |
| South Florida Vision | Fort Lauderdale | Florida | 33309 | United States |
| Bowden Eye & Associates | Jacksonville | Florida | 32256 | United States |
| Shettle Eye Research, Inc. | Largo | Florida | 33773 | United States |
| Millenium Clinical Research | Miami | Florida | 33125 | United States |
| Millennium Clinical Research, Inc. | Miami | Florida | 33125 | United States |
| South Florida Research Center Inc. | Miami | Florida | 33135 | United States |
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| Lorites Medical Group | Miami | Florida | 33166 | United States |
| Pediatric & Adult Research Center, LLC | Orlando | Florida | 32825 | United States |
| Medsol Clinical Research Center | Port Charlotte | Florida | 33948 | United States |
| Score Physician Alliance, LLC | St. Petersburg | Florida | 33710 | United States |
| East Florida Eye Institute | Stuart | Florida | 34494 | United States |
| Andrew Gardner Logan, MD / dba Logan Ophthalmic Research, LLC | Tamarac | Florida | 33321 | United States |
| Logan Ophthalmic Research, LLC | Tamarac | Florida | 33321 | United States |
| International Research Center | Tampa | Florida | 33603 | United States |
| Eye Care Centers Management, Inc. | Morrow | Georgia | 30260 | United States |
| Jenkins Eye Care | Honolulu | Hawaii | 96814 | United States |
| Saltzer Medical Group | Nampa | Idaho | 83686 | United States |
| Wohl Eye Center | Bloomingdale | Illinois | 60108 | United States |
| Jackson Eye | Lake Villa | Illinois | 60046 | United States |
| Illinois Eye Center | Peoria | Illinois | 61615 | United States |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | United States |
| Midwest Cornea Associates, LLC | Indianapolis | Indiana | 46290 | United States |
| Sabates Eye Centers | Leawood | Kansas | 66211 | United States |
| Kannarr Eye Care | Pittsburg | Kansas | 66762 | United States |
| Cincinnati Eye Institute | Edgewood | Kentucky | 41017 | United States |
| Koffler Vision Group | Lexington | Kentucky | 40509 | United States |
| Kentucky Eye Institute | Lexington | Kentucky | 40517 | United States |
| The Eye Care Institute | Louisville | Kentucky | 40206 | United States |
| Dr. Haider Eye Care | Louisville | Kentucky | 40220 | United States |
| Senior Health Services | Louisville | Kentucky | 40220 | United States |
| Baker, Carl W | Paducah | Kentucky | 42001 | United States |
| Lakeview Vision | Gretna | Louisiana | 70056 | United States |
| Eye Associates of Northeast Louisiana dba Haik Humble Eye Center | West Monroe | Louisiana | 71291 | United States |
| Eye Center Northeast | Bangor | Maine | 04401 | United States |
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
| NECCR PrimaCare Research | Fall River | Massachusetts | 02721 | United States |
| Shire Call Center | Lexington | Massachusetts | 02421 | United States |
| Clinical Eye Research of Boston | Winchester | Massachusetts | 02114 | United States |
| Minnesota Eye Consultants, P.A | Bloomington | Minnesota | 55431 | United States |
| Lifelong Vision Foundation | Chesterfield | Missouri | 63017 | United States |
| Silverstein Eye Centers | Kansas City | Missouri | 64133 | United States |
| Moyes Eye Center | Kansas City | Missouri | 64154 | United States |
| Mercy Research | Springfield | Missouri | 65806 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Opthalmology Consultants Ltd. | St Louis | Missouri | 63131 | United States |
| NV Eye Physicians | Henderson | Nevada | 89074 | United States |
| Wellish Vision Institute | Las Vegas | Nevada | 89119 | United States |
| Emil A. Stein, M.D., Ltd. | Las Vegas | Nevada | 89129 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Northern New Jersey Eye Institute | South Orange | New Jersey | 07079 | United States |
| Farkas, Kassalow, Resnick &Associates | New York | New York | 10022 | United States |
| Fichte, Endl& Elmer Eyecare | Niagara Falls | New York | 14304 | United States |
| South Shore Eye Care | Wantagh | New York | 11793 | United States |
| Oculus Research at Garner EyeCareCenter | Raleigh | North Carolina | 27603 | United States |
| James Branch, M.D. | Winston-Salem | North Carolina | 27101 | United States |
| Apex Eye Kenwood | Cincinnati | Ohio | 45236 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Apex Eye | Cincinnati | Ohio | 45247 | United States |
| Cleveland Eye Clinic | Cleveland | Ohio | 44141 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| The Columbus Eye Center | Columbus | Ohio | 43215 | United States |
| SkyVision Centers | Westlake | Ohio | 44145 | United States |
| IPS Research Company* | Oklahoma City | Oklahoma | 73120 | United States |
| Pacific Clear Vision Institute | Eugene | Oregon | 97401 | United States |
| Matossian Eye Associates | Doylestown | Pennsylvania | 18902 | United States |
| Philadelphia Eye Associates | Philadelphia | Pennsylvania | 19148 | United States |
| UPMC Eye Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Wyomissing Optometric Center | Wyomissing | Pennsylvania | 19610 | United States |
| Bluestein Custom Vision | Charleston | South Carolina | 29414 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 59101 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Eye Specialty Group | Memphis | Tennessee | 38120 | United States |
| Nashville Vision Associates | Nashville | Tennessee | 37205 | United States |
| Toyos Clinic | Nashville | Tennessee | 37215 | United States |
| Eyeland Vision | El Paso | Texas | 79934 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| Advanced Laser Vision & Surgical Institute | Houston | Texas | 77034 | United States |
| Lake Travis Eye & Laser Center | Lakeway | Texas | 78734 | United States |
| DCT- Shah Research, LLC dba Discovery Clinical Trials | Mission | Texas | 78572 | United States |
| Sun Research Institute, LLC | San Antonio | Texas | 78215 | United States |
| R and R Eye Research, LLC. | San Antonio | Texas | 78229 | United States |
| Lone Star Eye Care, P.A. | Sugar Land | Texas | 77479 | United States |
| Ericksen Research & Development, LLC | Clinton | Utah | 84015 | United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84117 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
| Emerson Clinical Research Institute | Falls Church | Virginia | 22046 | United States |
| Piedmont Eye Center, Inc. | Lynchburg | Virginia | 24502 | United States |
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| University of the Sunshine Coast Clinical Trials Centre | Sippy Downs | Queensland | 4556 | Australia |
| Augenklinik, Studienzentrum, Kepler-Universitätsklinikum GmbH | Linz | 4020 | Austria |
| AKH - Medizinische Universitaet Wien | Vienna | 1090 | Austria |
| Vienna Institute for Research in Ocular Surgery | Vienna | 1140 | Austria |
| The Ottawa Hospital - General Campus, University of Ottawa Eye Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| University of Waterloo School of Optometry and Vision Science | Waterloo | Ontario | N2L 3G1 | Canada |
| Eye Clinic Dr Kirsta Turman (Kreutzwaldi Silmakeskus) | Tallinn | 10120 | Estonia |
| East Tallinn Central Hospital Eye Clinic | Tallinn | 10138 | Estonia |
| Tartu University Hospital | Tartu | 51010 | Estonia |
| CHU Limoges - Hopital Dupuytren | Limoges | Haute Vienne | 87042 | France |
| SZTE Szemeszeti Klinika | Szeged | Csongrád megye | 6720 | Hungary |
| Bugat Pal Hospital Clinexpert Gyongyos | Gyöngyös | Heves County | 3200 | Hungary |
| Debreceni Egyetem | Debrecen | 4032 | Hungary |
| Kaposi Mór Hospital | Kaposvár | 7400 | Hungary |
| Csolnoky Ferenc Korhaz | Veszprém | 8200 | Hungary |
| HaEmek Medical Center | Afula | 18341 | Israel |
| Soroka University Medical Center | Beersheba | 84101 | Israel |
| Rambam MC | Haifa | 3109601 | Israel |
| Sharey Zedek MC | Jerusalem | 9103102 | Israel |
| Rabin Medical Center-Beilinson Campus. | Petah Tikva | 49100 | Israel |
| Kaplan Medical Center | Rehovot | 76100 | Israel |
| Tel Aviv Medical Center | Tel Aviv | 64239 | Israel |
| A.O.U. Policlinico San'Orsola-Malpighi | Bologna | 40138 | Italy |
| Centrum Medyczne Uno-Med | Krakow | Malopolska | 31-070 | Poland |
| Szpital Specjalistyczny nr 1 | Bytom | 41-902 | Poland |
| Centrum Diagnostyki i Mikrochirurgii Oka LENS | Olsztyn | 10-424 | Poland |
| Centrum Medyczne Uno-Med | Tarnów | 33-100 | Poland |
| Retina Sp. z o.o. | Warsaw | 01 -364 | Poland |
| Emanuelli Research & Development Center, LLC | Arecibo | 00613 | Puerto Rico |
| Centro Dotal de Investigaciones de Servicios de Salud | Carolina | 00984 | Puerto Rico |
| Berrocal and Associates | San Juan | 00907 | Puerto Rico |
| Newtown Clinical Research Centre | Johannesburg | Gauteng | 2001 | South Africa |
| Pretoria Eye Institute | Pretoria | Gauteng | 0082 | South Africa |
| Into Research | Pretoria | Gauteng | 0181 | South Africa |
| Instituto Oftalmológico Fernández-Vega | Oviedo | Principality of Asturias | 33012 | Spain |
| Clinica Oftalmologia Gil Piña | Huelva | 21002 | Spain |
| Clinica Rementeria | Madrid | 28010 | Spain |
| Cartujavision | Seville | 41092 | Spain |
Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days.
| FG002 | Placebo | Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
ITT population included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SHP640 | Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days. |
| BG001 | PVP-I 0.6% | Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days. |
| BG002 | Placebo | Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Clinical Resolution Among Who Received SHP640 or Placebo on Day 5 | Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from validated bulbar redness (VBR) scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%. | Modified intent-to-treat (mITT) population included participants who received at least one dose of investigational product (IP) and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Analysis was done in SHP640 and placebo reporting groups only. | Posted | Count of Participants | Participants | Day 5 |
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| Secondary | Number of Participants With Bacterial Eradication Among Who Received SHP640 or Placebo on Day 5 | Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on colony-forming unit (CFU)/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. Data analysis was performed in SHP640 and placebo reporting groups only but not in PVP-I 0.6%. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Posted | Count of Participants | Participants | Baseline, Day 5 |
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| Secondary | Number of Participants With Clinical Resolution | Clinical resolution was defined as absence (score=0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with score of atleast 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Posted | Count of Participants | Participants | Day 3, 8 and 12 |
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| Secondary | Number of Participants With Bacterial Eradication | Bacterial eradication was defined as absence of all bacterial species present at or above pathological threshold at baseline in the study eye. Bacterial species were identified by Matrix Assisted Laser Desorption/Ionization-Time of Flight Mass Spectrometry, using their unique protein patterns. Pathological threshold for individual bacterial species was based on CFU/mL threshold levels established by Cagle and modified by Leibowitz for different ocular bacterial species found in the specimens collected from each participant. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. | Posted | Count of Participants | Participants | Day 3, 8 and 12 |
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| Secondary | Bulbar Conjunctival Injection Score | Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | Score on a scale | Day 3, 5, 8 and 12 |
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| Secondary | Change From Baseline in the Bulbar Conjunctival Injection Score | Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Day 3, 5, 8 and 12 |
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| Secondary | Ocular Conjunctival Discharge Score | Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | Score on a scale | Day 3, 5, 8 and 12 |
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| Secondary | Change From Baseline in the Ocular Conjunctival Discharge Score | Ocular conjunctival discharge was assessed based on a 0 (No evidence of discharge in the conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Day 3, 5, 8 and 12 |
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| Secondary | Global Clinical Score | Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | Score on a scale | Day 3, 5, 8 and 12 |
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| Secondary | Change From Baseline in the Global Clinical Score | Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. The study eye was defined as an eye with a score of at least 1 for both ocular conjunctival discharge and bulbar conjunctival redness at baseline. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Day 3, 5, 8 and 12 |
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| Secondary | Number of Participants With Modified Clinical Resolution | Modified clinical resolution was defined as a global clinical score of 0 or 1. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Posted | Count of Participants | Participants | Day 3, 5, 8 and 12 |
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| Secondary | Number of Participants With Expanded Clinical Resolution | Expanded clinical resolution was defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2. Global clinical score was defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge scores. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Posted | Count of Participants | Participants | Day 3, 5, 8 and 12 |
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| Secondary | Time to Clinical Resolution | Clinical resolution was defined as absence (score of 0) of bulbar conjunctival injection and ocular conjunctival discharge in the study eye. Bulbar conjunctival injection was assessed based on 0 (Normal conjunctival vascular pattern) - 4 (Markedly prominent, intense diffuse hyperemia) scale which used pictures from VBR scale. Ocular conjunctival discharge was assessed based on 0 (No evidence of discharge in conjunctiva) - 3 (Abundant quantity of mucopurulent or purulent discharge) scale. Time to clinical resolution defined as the date on which a participant first reached clinical resolution minus the date of first dose of investigational product, plus 1. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. | Posted | Median | 95% Confidence Interval | Days | Baseline to Day 12 |
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| Secondary | Number of Participants Who Used Rescue Medication | Rescue treatment with a licensed antibiotic according to the local standard of care was provided to participants if, in the judgment of the investigator, there was no clinical improvement or worsening of their condition to an extent that it would be in the best interest of the participant treated with an alternate therapy for safety reasons. | mITT population included participants who received at least one dose of IP and had a positive bacterial culture (presence of one or more bacterial species at or above pathological threshold) at baseline in the study. Here, the number of participants analyzed refer to the participants evaluable for this outcome at specified time point. | Posted | Count of Participants | Participants | Baseline to Day 12 |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | An adverse event (AE) was 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. Any AE that occured after the first dose of investigational product instillation was considered a TEAE. | Safety population included all participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | From start of study drug administration up to 14 days |
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From start of study drug administration up to 14 days.
One participant was randomized in error and therefore captured in the ITT population, but not in the Safety Population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | SHP640 | Participants administered 1 drop of SHP640 ophthalmic suspension in each eye QID for 7 days. | 0 | 323 | 0 | 323 | 67 | 323 |
| EG001 | PVP-I 0.6% | Participants administered 1 drop of PVP-I 0.6% ophthalmic solution in each eye QID for 7 days. | 0 | 108 | 0 | 108 | 26 | 108 |
| EG002 | Placebo | Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days. | 0 | 321 | 0 | 321 | 7 | 321 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Instillation site pain | General disorders | MedDRA 19.1 | Non-systematic Assessment |
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If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Nov 28, 2016 | Sep 23, 2019 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Feb 15, 2017 | Sep 23, 2019 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 3 | Dec 13, 2017 | Sep 23, 2019 | Prot_003.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 4 | Jul 31, 2018 | Sep 23, 2019 | Prot_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2018 | Sep 23, 2019 | SAP_005.pdf |
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Not reported |
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| Other |
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| Asian |
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| Black or African American |
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| White |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Multiple |
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| OG002 | Placebo | Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days. |
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| Placebo |
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days. |
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Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days. |
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Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days. |
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| OG002 |
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Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days. |
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| Placebo |
Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days. |
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Participants administered 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
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