Trial Outcomes & Findings for Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions (NCT NCT01240122)

Results Overview

All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4

Results posted on

2025-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Biotrue/Investigational MPS Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
Overall Study STARTED	29
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Biotrue/Investigational MPS n=29 Participants Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
Age, Customized <18 years	0 participants n=5 Participants
Age, Customized 18 years of age or older	29 participants n=5 Participants
Sex/Gender, Customized Male	0 participants n=5 Participants
Sex/Gender, Customized Female	0 participants n=5 Participants
Sex/Gender, Customized Unknown	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4

Population: Corneal Staining Severity at Scheduled Visits (Safety Population)

All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.

Outcome measures

Outcome measures
Measure	Biotrue n=29 Participants Paired/parallel eye evaluation; each subject was treated with Biotrue, and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.	Investigational MPS n=29 Participants Paired/parallel eye evaluation; each subject used both used the Investigational MPS and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
Corneal Staining by Wear Time Staining at 1 Hour, Day 1	19 participants	15 participants
Corneal Staining by Wear Time Staining at 2 Hours, Day 2	19 participants	7 participants
Corneal Staining by Wear Time Staining at 4 Hours, Day 3	21 participants	5 participants
Corneal Staining by Wear Time Staining at End of Day, Day 4	18 participants	8 participants

SECONDARY outcome

Timeframe: Day 4

Population: All subjects who completed the study were included in the analysis per protocol.

All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference.

Outcome measures

Outcome measures
Measure	Biotrue n=28 Participants Paired/parallel eye evaluation; each subject was treated with Biotrue, and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.	Investigational MPS n=28 Participants Paired/parallel eye evaluation; each subject used both used the Investigational MPS and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
Subjective Solution Preference Subject preferred the solution	6 Participants	7 Participants
Subjective Solution Preference Subject did not prefer the solution	7 Participants	6 Participants
Subjective Solution Preference Subject reported solutions were about the same	15 Participants	15 Participants

SECONDARY outcome

Timeframe: Day 4

Population: All subjects who completed the study were included in the analysis per protocol.

All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt.

Outcome measures

Outcome measures
Measure	Biotrue n=29 Participants Paired/parallel eye evaluation; each subject was treated with Biotrue, and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.	Investigational MPS n=29 Participants Paired/parallel eye evaluation; each subject used both used the Investigational MPS and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
Overall Ocular Comfort	8.3 score on a scale Standard Deviation 1.74	8.4 score on a scale Standard Deviation 1.48

Adverse Events

Biotrue/Investigational MPS

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

Senior Manager, Clinical Research

Abbott Medical Optics

Phone: 714.247.8723

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place