Patient Satisfaction With Timolol in Subjects With Open-Angle Glaucoma or Ocular Hypertension
18. februar 2015 oppdatert av: Vistakon Pharmaceuticals
Patient Satisfaction With Timolol Maleate in Sorbate, Generic Timolol Gel Forming Solution or Timolol Hemihydrate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
This study compares patient symptoms and anterior segment safety in patients treated with timolol hemihydrate, generic timolol gel forming solution or timolol maleate.
Studieoversikt
Status
Fullført
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Illinois
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Bourbonnais, Illinois, Forente stater
-
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North Carolina
-
Charlotte, North Carolina, Forente stater
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- willing to comply with investigator's and protocol's instructions
- patients signature on the informed consent document
- primary open-angle glaucoma, pigment dispersion or exfoliation glaucoma, or ocular hypertension in at least one eye
- at screening intraocular pressure must be considered to be safe, in both eyes
- in non-qualifying eyes the intraocular pressure should be able to be controlled safely on no pharmacologic therapy or on study medicine alone
- currently treated with one glaucoma medication, untreated intraocular pressure of less than or equal to 28 mm Hg at visit 2 in both eyes
Exclusion Criteria:
- any abnormality preventing reliable applanation tonometry in either eye
- any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber in either eye
- any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye
- any history of allergic hypersensitivity or poor tolerance to any components of the preparations used in this trial
- females of childbearing potential not using reliable means of birth control
- pregnant or lactating females
- any clinically significant, serious, or severe medical or psychiatric condition
- participation (or current participation) in any investigational drug or device trial within 30 days prior to Visit 1
- severe prior visual acuity or field loss from any cause
- inability to understand the trial procedures, and thus inability to give informed consent
- progressive retinal or optic nerve disease apart from glaucoma
- serious systemic or ocular disease
- intraocular laser surgery within the past three months or corneal or intraocular conventional surgery within the past 6 months
- concurrent use of systemic corticosteroids, by IV, oral, dermal or topical ophthalmic route.
- subjects requiring tear replacement drops or allergy medications with sympathomimetics 24 hours prior to a scheduled study visit
- contraindication to beta-blocker usage including: reactive airway disease, uncontrolled heart failure, or second as well as third degree cardiac block, myasthenia gravis
- any subject the investigator believes will be at risk for glaucomatous progression by their participation in this trial
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: hemihydrate/maleate/maleate gel
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
|
0.5%
0.5%
0.5%
|
|
Aktiv komparator: maleate/maleate gel/hemihydrate
Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
|
0.5%
0.5%
0.5%
|
|
Aktiv komparator: maleate gel/hemihydrate/maleate
Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
|
0.5%
0.5%
0.5%
|
|
Aktiv komparator: hemihydrate/maleate gel/maleate
Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
|
0.5%
0.5%
0.5%
|
|
Aktiv komparator: maleate/hemihydrate/maleate gel
Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
|
0.5%
0.5%
0.5%
|
|
Aktiv komparator: maleate gel, maleate, hemihydrate
Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
|
0.5%
0.5%
0.5%
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Stinging on Instillation
Tidsramme: following 3 days of treatment
|
Assessed from subject response to survey question asking about tolerability of medicine upon instillation, using a 0 through 7 scale, with 0=complete comfort and 7=worst pain imaginable.
|
following 3 days of treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Conjunctival Hyperemia
Tidsramme: following 3 days of treatment
|
Assessed by investigator using a slit lamp and a photographic grading scale.
Photographs were graded: grade 0, grade 1, grade 2, grade 3. The higher the graded the worse the hyperemia.
|
following 3 days of treatment
|
|
Tear Film Break-up Time
Tidsramme: following 3 days of treatment
|
following 3 days of treatment
|
|
|
Corneal Staining Grade
Tidsramme: following 3 days of treatment
|
Assessed by the investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5.
The higher the grade the worse the staining.
|
following 3 days of treatment
|
|
Corneal Staining Count
Tidsramme: following 3 days of treatment
|
Assessed by the investigator using a slit lamp, counting the number of spots.
|
following 3 days of treatment
|
|
Intraoclular Pressure
Tidsramme: following 3 days of treatment
|
following 3 days of treatment
|
|
|
Basic Schirmer's
Tidsramme: following 3 days of treatment
|
Schirmer's measures basic tear function.
The higher the number, the less dry the eye.
|
following 3 days of treatment
|
|
Conjunctival Staining - Nasal Grade
Tidsramme: following 3 days of treatment
|
Assessed by investigator using a slit lamp and the Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided.
The higher the grade the worse the staining.
|
following 3 days of treatment
|
|
Conjunctival Staining - Nasal Count
Tidsramme: following 3 days of treatment
|
Assessed by investigator using slit lamp and counting number of spots.
|
following 3 days of treatment
|
|
Conjunctival Staining - Temporal Grade
Tidsramme: following 3 days of treatment
|
Assessed by investigator using a slit lamp and Oxford Scheme, grading 0,1,2,3,4,5 according to pictures provided.
The higher the grade the worse the staining.
|
following 3 days of treatment
|
|
Conjunctival Staining - Temporal Count
Tidsramme: following 3 days of treatment
|
Assessed by investigator using a slit lamp and counting number of spots.
|
following 3 days of treatment
|
|
Visual Acuity
Tidsramme: following 3 days of treatment
|
The visual acuity score is a count of the number of letters the subject successfully read from the eye chart.
The higher the score, the better the vision.
|
following 3 days of treatment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: William C. Stewart, MD, PRN Pharmacuetical Research Network, LLC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2008
Primær fullføring (Faktiske)
1. desember 2008
Studiet fullført (Faktiske)
1. desember 2008
Datoer for studieregistrering
Først innsendt
5. desember 2008
Først innsendt som oppfylte QC-kriteriene
5. desember 2008
Først lagt ut (Anslag)
9. desember 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. mars 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. februar 2015
Sist bekreftet
1. februar 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Øyesykdommer
- Grønn stær
- Glaukom, åpen vinkel
- Okulær hypertensjon
- Hypertensjon
- Fysiologiske effekter av legemidler
- Adrenerge beta-antagonister
- Adrenerge antagonister
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Antihypertensive midler
- Enzymhemmere
- Timolol
- Maleinsyre
Andre studie-ID-numre
- VPH0111
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