Trial Outcomes & Findings for Study of A New Contact Lens Cleaning and Disinfecting Solution (NCT NCT01318577)

Results Overview

Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

444 participants

Primary outcome timeframe

3 months

Results posted on

2020-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational Solution Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses. Investigational Cleaning \& Disinfecting Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution	Clear Care Solution Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses Clear Care Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
Overall Study STARTED	224	220
Overall Study COMPLETED	211	212
Overall Study NOT COMPLETED	13	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of A New Contact Lens Cleaning and Disinfecting Solution

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational Solution n=222 Participants Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses. Investigational Cleaning \& Disinfecting Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution	Clear Care Solution n=218 Participants Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses Clear Care Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution	Total n=440 Participants Total of all reporting groups
Age, Continuous	35.4 years n=5 Participants	35.3 years n=7 Participants	35.4 years n=5 Participants
Sex: Female, Male Female	160 Participants n=5 Participants	163 Participants n=7 Participants	323 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	55 Participants n=7 Participants	117 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: There were 442 dispensed eyes with nonmissing scores in the investigational group and 438 dispensed eyes with nonmissing scores in the Clear Care group.

Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities.

Outcome measures

Outcome measures
Measure	Investigational Solution n=442 eyes Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses. Investigational Cleaning \& Disinfecting Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution	Clear Care Solution n=436 eyes Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses Clear Care Solution: Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
Percentage of Eyes With > Grade 2 Slit Lamp Findings	4 eyes	0 eyes

Adverse Events

Investigational Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Clear Care Solution

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

Study Director

Bausch Health

Phone: 585-338-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER