An interventional study of Phase A - olifilcon B with Tangible Coatings and Phase B - etafilcon A with Tangible Coatings in Refractive Errors, sponsored by Vision Service Plan. Completed at 6 sites in United States. Open to participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-06.
Sponsored by Vision Service Plan · Not applicable, Interventional, and Treatment
The study will compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .
The primary outcome variables for this study are subjective comfort and lens preference.
The objective of the study is to compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel olifilcon B with Tangible Coating daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel etafilcon A with Tangible Coating spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. .
The primary outcome variables for this study are subjective comfort and lens preference.
413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.
This study's enrollment of 144 is above the median of 82 across 296 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →Vision Service Plan is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
Device: Phase A - olifilcon B with Tangible Coatings
1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
Device: Phase A - olifilcon B with Tangible Coatings
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses.
Device: Phase A - olifilcon B with Tangible Coatings
1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
Device: Phase A - olifilcon B with Tangible Coatings
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses.
Device: Phase A - olifilcon B with Tangible Coatings
1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
Device: Phase A - olifilcon B with Tangible Coatings
1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
Device: Phase B - etafilcon A with Tangible Coatings
1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Device: Phase B - etafilcon A with Tangible Coatings
1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses.
Device: Phase B - etafilcon A with Tangible Coatings
1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Device: Phase B - etafilcon A with Tangible Coatings
1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses.
Device: Phase B - etafilcon A with Tangible Coatings
1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Device: Phase B - etafilcon A with Tangible Coatings
Daily disposable silicone hydrogel contact lens
Daily disposable hydrogel contact lens
Subjective Lens Preference
Subjective preference for either lens intervention or no preference. Likert question with forced preference for Test or Benchmark lens or no preference.
Time frame: Visit 3 - Approximately 2 weeks
8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score
Difference in CLDEQ-8 score with treatments relative to score with habitual lenses. The scale on the 8-item CLDEQ-8 instrument is from 1 to 33, with each item having a possible 4 or 5 points.
Time frame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Plan to share: No
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This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Vision Service Plan