- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03670277
Evaluation of On-eye Optical Performances of the RMY-100 Lens
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Ontario
-
Waterloo, Ontario, Canada
- Centre for Ocular Research & Education
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- Pediatric subjects (<18 years old) must read (or be read to), understand, and sign the Statement of Information and Assent and receive a fully executed copy of the form.
- Adult subjects (≥18 years old) and parent(s) or legal guardian(s) of pediatric subjects must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Between 7 and 25 years of age (inclusive).
- Have normal eyes (i.e., no ocular medications or infections of any type).
- Vertex-corrected distance subjective best-sphere refraction must be between -1.00D and -5.00D (inclusive) in each eye.
- Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.
Have sphero-cylindrical best-corrected visual acuity of 20/25 or better in each eye.
Below inclusion criterion is for subjects to be enrolled to the Control group only:
Are existing orthokeratology patients whose current treatment has been stabilized for at least 1 months and with complete pre-treatment record, e.g., spherocylindrical refraction and corneal topography. Pre-treatment wavefront aberration measures are preferred by not required.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating.
- Any systemic allergies, infectious disease (e.g., hepatitis, tuberculosis), autoimmune disease (e.g., rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
- Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear and/or participation in the study.
- Any current use of ocular topical medication (occasional use of re-wetting drops is allowed).
- Any previous or planned ocular or intraocular surgery, including refractive surgery.
- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- Employee or their children/relatives of investigational clinic (e.g., Investigator, Coordinator, Technician). 8 . Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to, aphakia, uveitis, ocular hypertension, glaucoma, severe keratoconjunctivitis sicca, history of recurrent corneal erosions, keratoconus, keratoconus suspect, pellucid marginal degeneration, entropion, ectropion, extrusions, chalazia, and recurrent styes.
9 . Any Grade 3 or greater slit lamp findings (eg, edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) on the FDA scale.
10 . Any ocular abnormality that is contraindicated contact lens wear. 11 . Any corneal scar within central 5mm 12 . Binocular vision abnormality, intermittent strabismus or strabismus. Below exclusion criteria are for subjects to be enrolled to the Test group only 13 . Current or recent (within 30 days from enrollment) rigid lens wearers. 14 . History of orthokeratology treatment. 15. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas permeable contact lens wear.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: TEST arm
For subjects enrolled in the Test arm, the Test Soft Contact Lens will be bilaterally fitted to the subject's eyes.
Endpoint measures will be collected over one eye only - Test Arm: OD only.
|
Test Soft Contact Lens
|
Sperimentale: CONTROL arm
Subjects enrolled in the Control Arm will be established orthokeratology lens wearers.
Endpoint measures will be collected over one eye only - Control Arm: Better OK fitted eyes based on investigator's judgement.
|
CONTROL
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Distance Spherical Aberration (Z4, 0)
Lasso di tempo: Up to Post Lens Fitting Evaluation
|
Spherical aberration (Z4, 0) for a 5-mm pupil was measured by an aberrometer (COAS by AMO) with a distant viewing target at 4 m at the Baseline and post lens fitting.
The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye.
The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
|
Up to Post Lens Fitting Evaluation
|
Near Spherical Aberration (Z4, 0)
Lasso di tempo: Up to Post Lens Fitting Evaluation
|
Spherical aberration (Z4, 0) for a 5 mm pupil was measured by an aberrometer (COAS by AMO) with a near view target at 25 cm.
at the Baseline and post lens fitting.
The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye.
The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
|
Up to Post Lens Fitting Evaluation
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Distance Off-axis Refraction at ±10°, ±20°, and ±30° Retinal Eccentricities.
Lasso di tempo: Up to Post Lens Fitting Evaluation
|
Distance off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with distant viewing targets at 4 m and ±10°, ±20°, and ±30° off axis. at the Baseline and post lens fitting.
The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye.
The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
|
Up to Post Lens Fitting Evaluation
|
Near Off-axis Refraction at ±30° Retinal Eccentricities.
Lasso di tempo: Up to Post Lens Fitting Evaluation
|
Near off-axis refractions were measured by an open-field autorefractor (WAM-5500 by Grand Seiko) with near viewing targets at 25 cm and ±30° off-axis.
at the Baseline and post lens fitting.
The Control Group only had 1 study Visit that record Baseline measurements, no intervention from the sponsor was implemented for this group, therefore data was collected on a bare eye.
The Test group was fitted with the study lens at Visit 2 and data was collected with the Test lens on eye.
|
Up to Post Lens Fitting Evaluation
|
Collaboratori e investigatori
Investigatori
- Cattedra di studio: Xu Cheng, Johnson & Johnson Vision Care, Inc.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- CR-6000
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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 .
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