Dispensing Study for the Phenacite Project
30 ottobre 2020 aggiornato da: CooperVision, Inc.
Dispensing Study for the Phenacite Project.
The investigational test lens was not the final optical design and the study was not used for design validation.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
25
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Indiana
-
Bloomington, Indiana, Stati Uniti, 47405
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 35 anni (Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Oculo-visual examination in the last two years
- Between 18 and 35 years of age and has full legal capacity to volunteer
- Has read and understood the informed consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
- Currently wears, or has previously successfully worn, soft contact lenses between -1.00D and -4.00D
- Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder ≤-0.75
- Has not worn lenses for at least 12 hours before the initial visit
- Has a subjective response at baseline, which indicates suitability for this study
- Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
- Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.
Exclusion Criteria:
- Has never worn contact lenses before
- Any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
- Has any ocular pathology or anomaly that would affect the wearing of the lenses
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
- Is aphakic
- Has anisometropia of >1.00
- Has undergone corneal refractive surgery
- Has strabismus
- Has any ocular amblyopia >= 1line of HC Visual Acuity
- Is participating in any other type of eye related clinical or research study
- Has participated in study CV-14-32.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Phenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
|
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
|
Comparatore attivo: comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Subjective Ratings of Lens Comfort
Lasso di tempo: Baseline (after 15 minutes of lens dispense)
|
Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings of Lens Comfort
Lasso di tempo: 2 Weeks
|
Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
|
2 Weeks
|
|
Over Refraction for Optimized Distance Acuity
Lasso di tempo: 2 weeks
|
Over Refraction for optimized distance acuity measured using logMAR
|
2 weeks
|
|
Binocular Distance Visual Acuity - High Illumination High Contrast
Lasso di tempo: Baseline (after 5 minutes of lens dispense)
|
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Distance Visual Acuity - High Illumination High Contrast
Lasso di tempo: 2 weeks
|
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Distance Visual Acuity - Low Illumination High Contrast
Lasso di tempo: Baseline (after 5 minutes of lens dispense)
|
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Distance Visual Acuity - Low Illumination High Contrast
Lasso di tempo: 2 weeks
|
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Near Visual Acuity - High Illumination High Contrast
Lasso di tempo: Baseline (after 5 minutes of lens dispense)
|
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Near Visual Acuity - High Illumination High Contrast
Lasso di tempo: 2 weeks
|
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Near Visual Acuity - Low Illumination High Contrast
Lasso di tempo: Baseline (after 5 minutes of lens dispense)
|
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Near Visual Acuity - Low Illumination High Contrast
Lasso di tempo: 2 weeks
|
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
2 weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Lens Fit - Post Blink Movement
Lasso di tempo: Baseline (after 15 minutes of lens dispense)
|
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
|
Baseline (after 15 minutes of lens dispense)
|
|
Lens Fit - Post Blink Movement
Lasso di tempo: 2 weeks
|
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
|
2 weeks
|
|
Push - Up Test for Lens Tightness
Lasso di tempo: Baseline (after 15 minutes of lens dispense)
|
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
|
Baseline (after 15 minutes of lens dispense)
|
|
Push - Up Test for Lens Tightness
Lasso di tempo: 2 weeks
|
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
|
2 weeks
|
|
Lens Mobility Rating
Lasso di tempo: Baseline (after 15 minutes of lens dispense)
|
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
|
Baseline (after 15 minutes of lens dispense)
|
|
Lens Mobility Rating
Lasso di tempo: 2 weeks
|
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
|
2 weeks
|
|
Overall Lens Fit Acceptance
Lasso di tempo: Baseline (after 15 minutes of lens dispense)
|
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
|
Baseline (after 15 minutes of lens dispense)
|
|
Overall Lens Fit Acceptance
Lasso di tempo: 2 weeks
|
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Distance Vision
Lasso di tempo: Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Distance Vision
Lasso di tempo: 2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Near Vision
Lasso di tempo: Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Near Vision
Lasso di tempo: 2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Computer Vision
Lasso di tempo: Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Computer Vision
Lasso di tempo: 2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Subjective Ratings for Vision Quality - Overall Vision
Lasso di tempo: Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Overall Vision
Lasso di tempo: 2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Corneal Staining Extent
Lasso di tempo: 2 weeks
|
Corneal staining extent was assessed on a scale of 0-4 (0-No Staining, 1 - 1-15% of area, 2- 16-30% of area, 3- 31-45% of area, 4- >45% of area
|
2 weeks
|
|
Conjunctival Staining
Lasso di tempo: 2 weeks
|
Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent
|
2 weeks
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Pete Kollbaun, OD PhD, CORL Indiana University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2015
Completamento primario (Effettivo)
1 luglio 2015
Completamento dello studio (Effettivo)
1 luglio 2015
Date di iscrizione allo studio
Primo inviato
1 maggio 2015
Primo inviato che soddisfa i criteri di controllo qualità
1 maggio 2015
Primo Inserito (Stima)
6 maggio 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 novembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 ottobre 2020
Ultimo verificato
1 ottobre 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CV-15-16
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Sì
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .