Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses evaluated in this study, For treatment- emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed in the corresponding lens sequence.
Appears in 3 contracts
Samples: Investigator Agreement, Investigator Agreement, Investigator Agreement
Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses evaluated in this study, . For treatment- treatment-emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed in the corresponding lens sequenceexposed.
Appears in 3 contracts
Samples: Investigator Agreement, Investigator Agreement, classic.clinicaltrials.gov
Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses evaluated in this study, For treatment- treatment-emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed in the corresponding lens sequenceexposed.
Appears in 2 contracts
Samples: Investigator Agreement, Investigator Agreement
Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses evaluated in this study, except for the lenses used with the purpose of power optimization. For treatment- treatment-emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed in the corresponding lens sequenceexposed.
Appears in 1 contract
Samples: Investigator Agreement
Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses evaluated in this study, . For treatment- treatment-emergent safety analyses, subjects/eyes will be categorized under the actual study lenses lens exposed in the corresponding lens sequence.
Appears in 1 contract
Samples: clinicaltrials.gov
Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses evaluated in this study, . For treatment- treatment-emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed in the corresponding lens sequence.
Appears in 1 contract
Samples: clinicaltrials.gov
Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses product evaluated in this study, except for the lenses used at Visit 2 for the purpose of parameter optimization and fitting as they are not intended for the assessment of safety. For treatment- emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed in the corresponding lens sequenceproduct exposed.
Appears in 1 contract
Samples: Investigator Agreement
Safety Analysis Set. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. As such, the safety analysis set will include all subjects/eyes exposed to any study lenses evaluated in this study, . For treatment- emergent safety analyses, subjects/eyes will be categorized under the actual study lenses exposed in the corresponding lens sequence.
Appears in 1 contract
Samples: Investigator Agreement