- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00721695
Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification.
16. juli 2014 opdateret af: Omeros Corporation
Randomized, Controlled, Double-Masked, Multicenter, Exploratory Study of the Clinical Benefit and Safety of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR) Using a Coaxial Phacoemulsification Process
This is an exploratory study to determine the safety and clinical benefit of OMS302 Injection in subjects undergoing Cataract Extraction with Lens Replacement (CELR) using a coaxial phacoemulsification process.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OMS302 Injection is a mydriatic/anti-inflammatory combination investigational drug product being developed as an irrigation solution during intracameral lens replacement surgical procedures of the eye.
OMS302 irrigation solution may induce and maintain an adequately dilated pupil and reduce postoperative symptoms of discomfort such as eye pain and irritation.
The use of OMS302 irrigation solution may eliminate the need for pre-operative dilation of the eye and could reduce the postoperative use of an anti-inflammatory and pain medications following surgery.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Redding, California, Forenede Stater, 96002
- Shasta Eye Medical Group
-
-
Minnesota
-
Bloomington, Minnesota, Forenede Stater, 55420
- Chu Vision Institute
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64133
- Silverstein Eye Centers
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53715
- Davis Duehr Dean
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Subject is 50 years of age or older.
- Subject is to undergo unilateral primary CELR for an age-related cataract under topical anesthesia and using a clear cornea incision.
- Subject's history and physical examination are within normal limits or the examination is clinically non-significant for purposes of the study as determined by the Investigator, and subject is in good general health.
- Subject has best corrected visual acuity (BCVA) of 20/400 or better in the non-study eye.
- Subject has intraocular pressure (IOP) between 5 mmHg and 22 mmHg, inclusive, in the study eye.
Exclusion Criteria:
- Subject is allergic to any of the individual ingredients in OMS302
- Subject who is taking medications with the same activities as that of the active ingredients in OMS302 for defined time intervals prior to and after surgery.
- Female subject of childbearing potential (i.e., not surgically sterilized nor post-menopausal longer than one year) who is not using an effective method of birth control within at least 14 days prior to surgery or has a positive pregnancy test.
- Subject who has a present condition or history of any clinically significant uncontrolled gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, connective tissue, respiratory, or medical disorder as determined by the Investigator.
- Subject who is taking anticoagulants.
- Subject who is taking or needs to take for the duration of the study any of the prohibited medications.
- Subject with pseudo-capsular exfoliation, or evidence of prior iritis or of ocular trauma with iris damage, or who has used pilocarpine within six months of screening.
- Subject that has uncontrolled chronic ocular disease.
- Subject that has active corneal pathology or scarring noted in either eye (except superficial punctate keratopathy in the non-study eye).
- Subject that has extraocular/intraocular inflammation in either eye.
- Subject has an active bacterial and/or viral infection in either eye.
- Subject that has narrow-angle glaucoma, unstable glaucoma, or glaucoma being treated with prostaglandins or prostaglandin analogues.
- Subject taking, or has taken within the past year, an alpha adrenergic antagonist.
- Subject that has participated in or is currently participating in any investigational drug or device trial within the previous 30 days prior to the day of surgery.
- Subject that has had intraocular conventional surgery within the past three months or intraocular laser surgery within one month of the planned surgery in the study eye.
- Subject that requires the use of other topical medications during the trial except prophylactic antibiotics, topical lid care or glaucoma medications or tear replacement solutions.
- Subject that needs other ocular surgery at the time of the cataract extraction.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 1
OMS302 Irrigation Solution
|
OMS302 Irrigation Solution
Andre navne:
|
|
Aktiv komparator: 2
OMS302-PE HCl Irrigation Solution
|
OMS302-PE HCI Irrigation Solution
Andre navne:
|
|
Placebo komparator: 3
Standard topical mydriatics and BSS Irrigation Solution
|
Standard topical mydriatics and Balanced Salt Solution Irrigation Solution
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pupil diameter
Tidsramme: Day of Surgery
|
Day of Surgery
|
|
Pain and other measures of ocular discomfort
Tidsramme: 14 days
|
14 days
|
|
Degree of inflammation in the anterior chamber
Tidsramme: 14 days
|
14 days
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Ocular safety and changes in visual activity and intraocular pressure
Tidsramme: 28 days
|
28 days
|
|
General measures of safety
Tidsramme: 28 days
|
28 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Scott Houston, Omeros Corporation
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Behndig A, Eriksson A. Evaluation of surgical performance with intracameral mydriatics in phacoemulsification surgery. Acta Ophthalmol Scand. 2004 Apr;82(2):144-7. doi: 10.1111/j.1600-0420.2004.00241.x.
- Lundberg B, Behndig A. Intracameral mydriatics in phacoemulsification cataract surgery. J Cataract Refract Surg. 2003 Dec;29(12):2366-71. doi: 10.1016/s0886-3350(03)00522-4.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2008
Primær færdiggørelse (Faktiske)
1. februar 2009
Studieafslutning (Faktiske)
1. februar 2009
Datoer for studieregistrering
Først indsendt
22. juli 2008
Først indsendt, der opfyldte QC-kriterier
22. juli 2008
Først opslået (Skøn)
24. juli 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juli 2014
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C07-005
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .