Trial Outcomes & Findings for Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types (NCT NCT01120782)

Results Overview

Number of subjects whose prescription is the same for the two lenses tested.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

after 15 minutes of lens wear

Results posted on

2018-06-19

Participant Flow

Due to test article shipment error, one clinical site did not receive control test article in a required cylinder and all screened/enrolled subject were unable to be fitted according to the protocol and were discontinued.

Participant milestones

Participant milestones
Measure	All Subjects All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
Overall Study STARTED	45
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
Overall Study Test article shipping error	11

Baseline Characteristics

Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=45 Participants All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
Age, Continuous	29.2 years STANDARD_DEVIATION 5.10 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: after 15 minutes of lens wear

Population: All completed subjects.

Number of subjects whose prescription is the same for the two lenses tested.

Outcome measures

Outcome measures
Measure	All Subjects n=34 Participants All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
Prescription Equivalence	34 participants

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ross Franklin, OD

Johnson & Johnson Vision Care

Phone: 1-904-443-1379

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication requires agreement and written authorization from Sponsor.
Publication restrictions are in place

Restriction type: OTHER