Trial Outcomes & Findings for Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan (NCT NCT02251561)

Results Overview

The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Day 1, after 2 hours of wear

Results posted on

2015-06-10

Participant Flow

Subjects were enrolled from one study site located in Japan.

Of the 36 subjects enrolled in the study, 8 were exited prior to product exposure \[did not meet eligibility criteria (5), and subject withdrawal (3)\]. This reporting group includes all subjects who used the study products (28).

Participant milestones

Participant milestones
Measure	FID 109182/Opti-Free Plus Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FID 109182/Opti-Free Plus n=28 Participants Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
Age, Continuous	28.0 years STANDARD_DEVIATION 7.5 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment Japan	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1, after 2 hours of wear

Population: This analysis population includes all subjects who used the study products and had examination/observation data after use.

The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.

Outcome measures

Outcome measures
Measure	FID 109182 n=27 Participants Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours	Opti-Free Plus n=27 Participants Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein	92.6 percentage of participants	22.2 percentage of participants

SECONDARY outcome

Timeframe: Day 1, after 2 hours of wear

Population: This analysis population includes all subjects who used the study products and had examination/observation data after use.

The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining area was evaluated for each eye individually against representative pictures and scored on a 0-3 scale \[0=No staining; 1=Staining with small area (1 to 25% of corneal surface); 2=Staining with medium area (26 to 50% of corneal surface); 3=Staining with large area (51% of corneal surface or greater)\]. Proportion of participants is reported as a percentage.

Outcome measures

Outcome measures
Measure	FID 109182 n=27 Participants Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours	Opti-Free Plus n=27 Participants Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein	92.6 percentage of participants	44.4 percentage of participants

Adverse Events

FID 109182

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Opti-Free Plus

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

Director, Clinical & Regulatory Affairs, Division of Medical Affairs

Alcon Japan, Ltd.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER