NCT04032457.
Methods | RCT, parallel‐group, cross‐over design |
Participants |
Inclusion criteria: 18 to 42 years of age; currently wearing spherical daily disposable contact lenses at least 5 days/week; vision correctable to 20/30 with spherical lenses in powers from +3.00 to +1.00 DS and from −1.00 to −7.00 DS; VA corrected to at least 20/30 with spherical contact lens Exclusion criteria: ocular or systemic disease that contraindicates SCL wear; sensitivity to diagnostic pharmaceuticals; pregnant, lactating, or planning pregnancy; aphakic; undergone refractive error surgery |
Interventions |
Phase 1 Olifilcon B with tangible coatings
Etafilcon A
Senofilcon A
Delefilcon A
Phase 2 Etafilcon A with tangible coatings
Etafilcon A
Nesofilcon A
Nelfilcon A
Notes: 2 phases, only 6 parallel groups in phase A compared silicone hydrogel SCL to daily SCL in 12 cross‐over interventions (12 participants in each intervention period); the other 6 groups in phase B compared a new‐to‐market hydrogel SCL to daily SCL |
Outcomes |
Primary outcome:
Secondary outcomes:
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Notes | Sponsorship source: Vision Service Plan Authors' names: Robin L Chalmers, OD (investigator), Alex Dreu, Plexus Optix (results) Institution: Vision Service Plan, Foresight Regulatory Strategies Inc. Comments: quality control review of results not completed; whether the analysis accounted for cross‐over design was unclear |