Trial Outcomes & Findings for Corneal Staining and Physiological Compromise After Eight Hours of Soft Contact Lens Wear (NCT NCT01015768)

Results Overview

The fluorescein dye diffusion rate in nanometers per second, is a diffusion rate into the corneal tissue. The fluorescein dye diffuses from the tears, where it is in high concentration, into the cornea, where it is in low concentration. It's diffusion is limited (or not) by the barrier properties and health of the epithelium.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

After eight hours of wear

Results posted on

2020-09-18

Participant Flow

Eyes were randomized to one of two conditions.

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Test Eye A new PureVision contact lens is soaked in ReNu Multiplus disinfecting solution and worn for 8 hours	Control A new PureVision contact lens is soaked in non-preserved saline and worn for 8 hours
Overall Study STARTED	30 30	30 30
Overall Study COMPLETED	26 26	26 26
Overall Study NOT COMPLETED	4 4	4 4

Reasons for withdrawal

Reasons for withdrawal
Measure	Test Eye A new PureVision contact lens is soaked in ReNu Multiplus disinfecting solution and worn for 8 hours	Control A new PureVision contact lens is soaked in non-preserved saline and worn for 8 hours
Overall Study Some subject data unuseable	4	4

Baseline Characteristics

Corneal Staining and Physiological Compromise After Eight Hours of Soft Contact Lens Wear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=30 Participants A new lens (PureVision) is soaked in ReNu Multiplus multipurpose soaking solution A new lens (PureVision) is soaked for 2 hours in non-preserved saline
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	25.2 years STANDARD_DEVIATION 2.1 • n=93 Participants
Sex: Female, Male Female	19 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Region of Enrollment United States	30 participants n=93 Participants
Permeability Rate, Pdc	0.05749 nanometers per second STANDARD_DEVIATION 0.038 • n=93 Participants

PRIMARY outcome

Timeframe: After eight hours of wear

Population: Analysis was per protocol.

The fluorescein dye diffusion rate in nanometers per second, is a diffusion rate into the corneal tissue. The fluorescein dye diffuses from the tears, where it is in high concentration, into the cornea, where it is in low concentration. It's diffusion is limited (or not) by the barrier properties and health of the epithelium.

Outcome measures

Outcome measures
Measure	PHMB-containing Disinfectant n=26 eyes New lens soaked in B\&L ReNu Multiplus disinfecting solution.	Non-preserved Saline n=26 eyes New lens soaked for two hours in non-preserved saline
The Primary Outcome Measure Will be Corneal Epithelial Dye Diffusion Rate in Nanometers Per Second, for the Test and Control Eyes.	0.0567 nanometers per second Standard Deviation 0.039	0.0583 nanometers per second Standard Deviation 0.038

PRIMARY outcome

Timeframe: After eight hours of wear

A penetration rate, in nm/sec

Outcome measures

Outcome measures
Measure	PHMB-containing Disinfectant n=30 eyes New lens soaked in B\&L ReNu Multiplus disinfecting solution.	Non-preserved Saline n=30 eyes New lens soaked for two hours in non-preserved saline
Permeability Rate, nm/Sec	0.057 nm/sec Standard Deviation 0.04	0.058 nm/sec Standard Deviation 0.04

SECONDARY outcome

Timeframe: After eight hours of wear

Corneal staining represents corneal abrasion or damage. It is graded by us on a 0 - 4 scale (4 being worst) in five corneal sectors. The total score per cornea or eye is thus graded on a 0 - 20 total scale.

Outcome measures

Outcome measures
Measure	PHMB-containing Disinfectant n=30 eyes New lens soaked in B\&L ReNu Multiplus disinfecting solution.	Non-preserved Saline n=30 eyes New lens soaked for two hours in non-preserved saline
The Secondary Outcome Measure Will be the Corneal Staining Grade, Compared Between the Test and Control Eye, as Well as Between the Baseline and Final Staining for Each Eye.	4.95 score on a scale Standard Deviation 2.4	4.52 score on a scale Standard Deviation 2.2

Adverse Events

Test Eye

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Jerry R. Paugh, OD, PhD

Southern California College of Optometry

Phone: 714-449-7487

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place