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One Month Daily Wear Clinical Evaluation of New Prototype Contact Lenses in Habitual and Neophyte Contact Lens Wearers

18 giugno 2018 aggiornato da: Johnson & Johnson Vision Care, Inc.

One Month Daily Wear Clinical Evaluation of Three Prototype Soft Contact Lenses in a Population of Habitual and Neophyte Contact Lens Wearers

There will be four study lenses tested; one marketed lens, and three prototype study lenses. Subjects will be randomized to one of the four study lenses which will be worn in a daily wear modality, with a two week replacement.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

80

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

  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 006

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 39 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. The subject must be between 18 and 39 years of age.
  2. The subject must be able to read and understand English.
  3. The subject read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
  4. The subject must not have been a participant in a contact lens or contact lens solution study/investigation in the previous seven days.
  5. The subject must be willing to wearthe study lenses for at least 6 hours per day, 7 days per week (e.g. does not regularly swim).
  6. The subject must appear able and willing and able to the adhere to the instructions set forth in this clinical protocol.
  7. The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -4.00D in each eye.
  8. The subject's refractive astigamatism must be less than or equal to -1.00D in both eyes.
  9. The subjet must have best corrected visual acuity of 20/30 (6/9 or +0.20 logMAR) or better in each eye.
  10. The subject must require a visual correction in both eyes (no monofit or monovision allowed).

  11. The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

    • No amblyopia
    • No evidence of lid abnormality or infection (including blepharitis/meibomitis)
    • No conjunctival abnormality or infection.
    • No clinically significant slit lamp findings (i.e. stromal edema, vascularization, corneal scaring, infiltrates or abnormal opacities).
    • No other active ocular diseases.

Exclusion Criteria:

  1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  2. Any systemic diseases, autoimmune disease, or use of medication, which may interfere with contact lens wear.
  3. Clinically significant (Grade 3 or 4) corneal edeam, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  4. Any ocular infection.
  5. Any corneal distortion resulting from previous hard or rigid permeable contact lens wear.
  6. Pregnancy or lactation (subjects who become pregnant during the study will be discontinued).
  7. No extended wear in the last 3 months.
  8. Diabetes.
  9. Infectious diseases (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
  10. Has had refractive surgery.
  11. Employee of VRF with direct involvement in the study or a family member of the clinic.

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 parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: etafilcon A
Marketed control soft contact lens
Dispositivo: ACUVUE 2
worn in a daily wear modality; lenses will be replaced after 2 weeks
Sperimentale: Prototype E1
Investigational soft contact lens
Dispositivo: Prototype E1
worn in a daily wear modality; lenses will be replaced after 2 weeks
Altri nomi:
  • Investigational soft contact lens
Sperimentale: Prototype E2
Investigational soft contact lens
Dispositivo: Prototype E2
worn in a daily wear modality; lenses will be replaced after 2 weeks
Altri nomi:
  • Investigational soft contact lens
Sperimentale: Prototype E3
Investigational soft contact lens
Dispositivo: Prototype E3
worn in a daily wear modality; lenses will be replaced after 2 weeks
Altri nomi:
  • Investigational soft contact lens

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Corneal Staining (Area)
Lasso di tempo: Baseline and 4-Week Follow-up
Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e. Grade 0= 0% of region covered, Grade 1 =10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4= 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered,Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered and Grade 10 = 100% of region covered). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.
Baseline and 4-Week Follow-up
Corneal Staining (Depth)
Lasso di tempo: Baseline and 4-Week Follow-up
Corneal Staining Depth was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 4-point scale (i.e. Grade 0= None, Grade 1 =Superficial epithelial, Grade 2 = Full epithelial, Grade 3 =stromal glow). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.
Baseline and 4-Week Follow-up
Corneal Staining (Type)
Lasso di tempo: Baseline and 4-Week Follow-up
Corneal Staining was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 =Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate and Grade 4 = Patch (greater or equal to 1mm). Central, interior, nasal, temporal and superior locations were evaluated. The average grade for each lens and time point was reported.
Baseline and 4-Week Follow-up
Limbal Conjunctival Redness
Lasso di tempo: Baseline and 2-Week Follow-up
Limbal Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Limbal Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for limbal redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.
Baseline and 2-Week Follow-up
Bulbar Conjunctival Redness
Lasso di tempo: Baseline and 2-Week Follow-up
Bulbar Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations. Bulbar Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for bulbar redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance. The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.
Baseline and 2-Week Follow-up
Visual Acuity (LogMAR)
Lasso di tempo: 4-Week Follow-up
Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations. The average visual acuity (LogMAR) for each lens was reported.
4-Week Follow-up
Lens Fitting Characteristics
Lasso di tempo: Post Lens Fitting and 4-Week Follow-up
Lens fit was assessed for each subject eye at post lens fitting and 4- week follow-up evaluations. Lens fit is a binary response as acceptable or unacceptable lens fit. The percentage of eyes with acceptable lens fit was reported.
Post Lens Fitting and 4-Week Follow-up
Percentage of Reported Ocular Symptoms (Burning/Stinging)
Lasso di tempo: Baseline and 4-Week Follow-up
The Ocular symptom Burning/Stinging was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Baseline and 4-Week Follow-up
Corneal Edema
Lasso di tempo: Baseline and 4-Week Follow-up
Corneal Edema was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Baseline and 4-Week Follow-up
Conjunctival Injection
Lasso di tempo: Baseline and 4-Week Follow-up
Conjunctival Injection was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Baseline and 4-Week Follow-up
Corneal Neovascularization
Lasso di tempo: Baseline and 4-Week Follow-up
Corneal Neovascularization was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Baseline and 4-Week Follow-up
Corneal Staining
Lasso di tempo: Baseline and 4-Week Follow-up
Corneal Staining was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The Percentage of eyes with Grade 3 or higher was reported.
Baseline and 4-Week Follow-up
Tarsal Abnormalities
Lasso di tempo: 1-, 2- and 4-Week Follow-up
Tarsal abnormalities were assessed using a biomicroscope at baseline, post lens fitting, 1-, 2- and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0, 1, 2, 3 and 4) with grade 0 represents the absence of abnormalities and 1 to 4 representing successively worse abnormalities (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). The percentage of eyes with Grade 3 or higher was reported.
1-, 2- and 4-Week Follow-up
Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy)
Lasso di tempo: Baseline and 4-Week Follow-up
The Ocular symptom Cloudy/Blurry/Hazy was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Baseline and 4-Week Follow-up
Percentage of Reported Ocular Symptoms (Dryness)
Lasso di tempo: Baseline and 4-Week Follow-up
The Ocular symptom Dryness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Baseline and 4-Week Follow-up
Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation)
Lasso di tempo: Baseline and 4-Week Follow-up
The Ocular symptom Grittiness/Foreign Body Sensation was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Baseline and 4-Week Follow-up
Percentage of Reported Ocular Symptoms (Irritation/Discomfort)
Lasso di tempo: Baseline and 4-Week Follow-up
The Ocular symptom Irritation/Discomfort was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Baseline and 4-Week Follow-up
Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness)
Lasso di tempo: Baseline and 4-Week Follow-up
The Ocular symptom Itchiness/Scratchiness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Baseline and 4-Week Follow-up
Percentage of Reported Ocular Symptoms (Lens Awareness)
Lasso di tempo: Baseline and 4-Week Follow-up
The Ocular symptom Lens awareness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Baseline and 4-Week Follow-up
Percentage of Reported Ocular Symptoms (Redness)
Lasso di tempo: Baseline and 4-Week Follow-up
The Ocular symptom Redness wasassessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Baseline and 4-Week Follow-up
Percentage of Reported Ocular Symptoms (Variable Vision)
Lasso di tempo: Baseline and 4-Week Follow-up
The Ocular symptom Variable Vision was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear. The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
Baseline and 4-Week Follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Johnson & Johnson Vision Care, Inc.

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 (Effettivo)

6 febbraio 2014

Completamento primario (Effettivo)

25 giugno 2014

Completamento dello studio (Effettivo)

25 giugno 2014

Date di iscrizione allo studio

Primo inviato

5 marzo 2014

Primo inviato che soddisfa i criteri di controllo qualità

6 marzo 2014

Primo Inserito (Stima)

7 marzo 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 giugno 2018

Ultimo verificato

1 luglio 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • CR-5146

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

prodotto fabbricato ed esportato dagli 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 .

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