Trial Outcomes & Findings for A Study to Evaluate a Modified Contact Lens (NCT NCT01391364)

Last Updated: 2020-09-30

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

Target enrollment

438 participants

Primary outcome timeframe

At 2 weeks follow up

Results posted on

2020-09-30

Participant Flow

There were 438 eligible participants (876 eyes) enrolled.

Participant milestones

Participant milestones
Measure	SofLens in Investigational Solution Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days.	SofLens in Currently Marketed Solution SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.
Overall Study STARTED	222	216
Overall Study COMPLETED	217	214
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate a Modified Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SofLens in Investigational Solution n=222 Participants Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days.	SofLens in Currently Marketed Solution n=215 Participants SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.	Total n=437 Participants Total of all reporting groups
Age, Continuous	27.9 years n=99 Participants	27.2 years n=107 Participants	27.6 years n=206 Participants
Sex: Female, Male Female	164 Participants n=99 Participants	146 Participants n=107 Participants	310 Participants n=206 Participants
Sex: Female, Male Male	58 Participants n=99 Participants	69 Participants n=107 Participants	127 Participants n=206 Participants

PRIMARY outcome

Timeframe: At 2 weeks follow up

Population: Dispensed eyes with nonmissing scores in each treatment group are included in the analysis population.

Outcome measures

Outcome measures
Measure	SofLens in Investigational Solution n=436 eyes Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days.	SofLens in Currently Marketed Solution n=430 eyes SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.
Percentage of Eyes With > Grade 2 Slit Lamp Findings	0 eyes	0 eyes

PRIMARY outcome

Timeframe: At 2 weeks follow up

Population: Eyes assessed for visual acuity at the 2 week follow up visit are included in the analysis population.

Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Outcome measures

Outcome measures
Measure	SofLens in Investigational Solution n=406 eyes Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days.	SofLens in Currently Marketed Solution n=400 eyes SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.
Visual Acuity	-0.051 logMAR Standard Deviation 0.062	-0.046 logMAR Standard Deviation 0.061

SECONDARY outcome

Timeframe: At 2 weeks follow up

Population: Eyes assessed for symptoms/complaints at the 2 week follow up visit are included in the analysis population.

Symptoms and complaints were assessed on a scale from 0 to 100, with 0 denoting the most unfavorable symptoms/complaints. Symptoms/complaints were collected by eye from each participant and based on the participant's experience with the study lenses. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, and Overall impression.

Outcome measures

Adverse Events

SofLens in Investigational Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

SofLens in Currently Marketed 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

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

Measure	SofLens in Investigational Solution n=434 eyes Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days.	SofLens in Currently Marketed Solution n=426 eyes SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.
Symptoms and Complaints Burning/stinging upon insertion	83.2 score on a scale Standard Deviation 20.5	86.8 score on a scale Standard Deviation 20.5
Symptoms and Complaints Comfort upon insertion	78.2 score on a scale Standard Deviation 20.4	82.7 score on a scale Standard Deviation 20.4
Symptoms and Complaints Overall comfort	77.6 score on a scale Standard Deviation 21.0	79.9 score on a scale Standard Deviation 20.9
Symptoms and Complaints Comfort at end of day	70.3 score on a scale Standard Deviation 23.8	70.5 score on a scale Standard Deviation 23.7
Symptoms and Complaints Ease of handling/insertion	73.1 score on a scale Standard Deviation 24.1	76.3 score on a scale Standard Deviation 24.1
Symptoms and Complaints Ease of handling/removal	87.1 score on a scale Standard Deviation 16.2	87.9 score on a scale Standard Deviation 16.2
Symptoms and Complaints Dryness	74.2 score on a scale Standard Deviation 24.2	74.5 score on a scale Standard Deviation 24.2
Symptoms and Complaints Itchiness	84.5 score on a scale Standard Deviation 19.1	87.7 score on a scale Standard Deviation 19.1
Symptoms and Complaints Redness	86.3 score on a scale Standard Deviation 17.4	89.2 score on a scale Standard Deviation 17.4
Symptoms and Complaints Vision upon insertion	86.7 score on a scale Standard Deviation 14.4	89.2 score on a scale Standard Deviation 14.4
Symptoms and Complaints Vision	87.7 score on a scale Standard Deviation 14.2	88.7 score on a scale Standard Deviation 14.2
Symptoms and Complaints Vision in low light	85.4 score on a scale Standard Deviation 14.6	86.7 score on a scale Standard Deviation 14.6
Symptoms and Complaints Lens cleanness upon insertion	90.2 score on a scale Standard Deviation 14.2	91.3 score on a scale Standard Deviation 14.2
Symptoms and Complaints Lens cleanness upon removal	84.6 score on a scale Standard Deviation 15.5	84.1 score on a scale Standard Deviation 15.5
Symptoms and Complaints Overall impression	73.7 score on a scale Standard Deviation 21.2	75.9 score on a scale Standard Deviation 21.1