Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers
Studieöversikt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Studietyp
Studietyp
Inskrivning (Faktisk)
Inskrivning
Fas
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
Florida
-
Jacksonville, Florida, Förenta staterna, 32256
- VRC East
-
-
Deltagandekriterier
Urvalskriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- The subject 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 18 and 35 (inclusive) years of age at the time of screening
- The subject must be habitual contact lens wearers (defined as minimum 6 hours per day, 5 days a week over the last month)
The subject must meet all of the following three criteria:
- The eyes' spherical equivalent distance refraction must be in the range of -1.00 to -9.00 D (inclusive)
- The eyes' refractive cylinder must be less than or equal to -0.75 DC
- Each eye must have best corrected visual acuity of 20/25 or better.
- The subject must have normal eyes (i.e., no ocular medications or infections of any type)
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 disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), 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 or may impact the functioning of the tear film (e.g., Isotretinoin)
- 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 entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
- Any current use of ocular medication
- Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
- Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron scale
- Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that would contraindicate contact lens wear
- Any known hypersensitivity or allergic reaction to contact lens care products.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment
- Employee of clinical site (e.g., Investigator, Coordinator, Technician)
- Current wearers of Acuvue Oasys 1-Day brand contact lenses
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Antal vapen
Vapen och interventioner
Deltagargrupp / ArmDeltagargrupp / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Experimentell: TEST/SCR
Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (TEST/SCR) sequentially
|
Acuvue Oasys 1-Day
Trial Frame with best spherocylindrical refraction (SCR)
|
|
Experimentell: SCR/TEST
Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (SCR/TEST) sequentially
|
Acuvue Oasys 1-Day
Trial Frame with best spherocylindrical refraction (SCR)
|
Vad mäter studien?
Primära resultatmått
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Acuity (logMAR)
Tidsram: 15 Minutes post Treatment Administration
|
Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration.
The average visual acuity for each lens type and condition was reported.
|
15 Minutes post Treatment Administration
|
Sekundära resultatmått
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Area Under Contrast Sensitivity Function Curve
Tidsram: 15 minutes post treatment administration
|
Contrast sensitivity was assessed in both eyes at 1.5, 3.0, 6.0, 12.5 and 18.0 cycles per degrees (cpd) using AST Sentio vision Testing System.
During testing 25 triplets of test letters were displayed on a large stationary monitor (118 CM), the operator recorded the patients responses using the remote (Android Tablet).
After a testing session had been completed the software calculated the Area under the log contrast sensitivity function from 1.5 cpd to 18 cpd.
|
15 minutes post treatment administration
|
Samarbetspartners och utredare
Sponsor
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Studiestart
Primärt slutförande (Faktisk)
Primärt slutförande
Avslutad studie (Faktisk)
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Första postat
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste uppdatering publicerad
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
Andra studie-ID-nummer
- CR-5968
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