Trial Outcomes & Findings for A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution (NCT NCT02701556)

Results Overview

A non-inferiority upper bound of 0.05 (5%) was used to assess the difference (Test - Control) in proportions of slit lamp outcomes. Graded slit lamp findings for each eye were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

396 participants

Primary outcome timeframe

3 months

Results posted on

2022-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Bausch & Lomb Investigational NNR06 Multi-Purpose Solution B \& L investigational NNR06 used as a rub care regimen (Test) NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.	COMPLETE Multi-Purpose Solution B\&L Multi-Purpose Solution as a rub care regimen (Control) Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
Overall Study STARTED	198	198
Overall Study COMPLETED	175	178
Overall Study NOT COMPLETED	23	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Safety and Effectiveness Study of a New Contact Lens Cleaning and Disinfecting Solution

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bausch & Lomb Investigational NNR06 Multi-Purpose Solution n=197 Participants B \& L investigational NNR06 used as a rub care regimen (Test) NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.	COMPLETE Multi-Purpose Solution n=198 Participants B\&L Multi-Purpose Solution as a rub care regimen (Control) Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.	Total n=395 Participants Total of all reporting groups
Age, Continuous	33.2 years STANDARD_DEVIATION 10 • n=5 Participants	33.7 years STANDARD_DEVIATION 8.9 • n=7 Participants	33.5 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	143 Participants n=5 Participants	142 Participants n=7 Participants	285 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	56 Participants n=7 Participants	110 Participants n=5 Participants
Region of Enrollment United States	197 Participants n=5 Participants	198 Participants n=7 Participants	395 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

A non-inferiority upper bound of 0.05 (5%) was used to assess the difference (Test - Control) in proportions of slit lamp outcomes. Graded slit lamp findings for each eye were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding).

Outcome measures

Outcome measures
Measure	Bausch & Lomb Investigational NNR06 Multi-Purpose Solution n=135 Participants B \& L investigational NNR06 used as a rub care regimen (Test) NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.	COMPLETE Multi-Purpose Solution n=116 Participants B\&L Multi-Purpose Solution as a rub care regimen (Control) Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
The Primary Safety Endpoint Was Statistical Non-inferiority With Respect to the Proportion of Eyes With Any Slit Lamp Findings Greater Than Grade 2 at Any Visit Between the Test and Control Solutions.	2 Participants	4 Participants

Adverse Events

Bausch & Lomb Investigational NNR06 Multi-Purpose Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

COMPLETE Multi-Purpose 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

Johnson Varughese

Valeant Pharmaceuticals

Phone: 908 927-1162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60