Trial Outcomes & Findings for Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens (NCT NCT01294917)

Results Overview

Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

4 weeks

Results posted on

2017-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
Overall Study STARTED	42
Overall Study Received Investigational MPS	36
Overall Study Received Clear Care	36
Overall Study Received OptiFree RepleniSH MPS	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
Overall Study Relocation	5
Overall Study Inconvenience	1

Baseline Characteristics

Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=42 Participants All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.1 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment Canada	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Only subjects that completed all three arms were included in analysis.

Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.

Outcome measures

Outcome measures
Measure	AMO Investigational MPS n=36 Participants All subjects received the AMO Investigational MPS for one month for the care of their soft contact lenses.	Clear Care n=36 Participants All subjects received the Clear Care for one month for the care of their soft contact lenses.	OptiFree RepleniSH MPS n=36 Participants All subjects received the OptiFree RepleniSH MPS for one month for the care of their soft contact lenses.
Corneal Staining	184 units on a scale Standard Deviation 381.6	46.6 units on a scale Standard Deviation 91.3	77.8 units on a scale Standard Deviation 131.7

SECONDARY outcome

Timeframe: 4 weeks

This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 weeks

This will be assessed by the tear break-up time on the lens surface, measured in seconds.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

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

Clinical Scientist

Centre for Contact Lens Research

Phone: 519-888-4567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place