Trial Outcomes & Findings for Evaluation of Two Daily Disposable Contact Lenses. (NCT NCT01300065)

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

441 participants

Primary outcome timeframe

2 weeks

Results posted on

2020-10-06

Participant Flow

There were 441 participants (882 eyes) enrolled, 221 in the test group and 220 in the control group. There were 434 eligible participants (868 eyes) who participated in the study, 216 in the test group and 218 in the control group.

Participant milestones

Participant milestones
Measure	Experimental- Soflens Bausch \& Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study	Marketed - Soflens Bausch \& Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study.
Overall Study STARTED	221	220
Overall Study COMPLETED	215	217
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Two Daily Disposable Contact Lenses.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental- Soflens n=215 Participants Bausch \& Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study	Marketed - Soflens n=216 Participants Bausch \& Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study.	Total n=431 Participants Total of all reporting groups
Age, Continuous	27.1 years n=5 Participants	26.6 years n=7 Participants	26.8 years n=5 Participants
Sex: Female, Male Female	140 Participants n=5 Participants	153 Participants n=7 Participants	293 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants	63 Participants n=7 Participants	138 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: There were 438 eyes in the test group and 434 eyes in the control group that were assessed for this outcome measure.

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	Experimental- Soflens n=438 eyes Bausch \& Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study	Marketed - Soflens n=434 eyes Bausch \& Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study.
Percentage of Eyes With > Grade 2 Slit Lamp Findings	0 eyes	0 eyes

SECONDARY outcome

Timeframe: At dispensing

Population: There were 426 eyes in the test group and 424 eyes in the control group that were assessed for this outcome measure.

A lens performance survey was given to each participant at the Screening/Dispensing Visit, three minutes following insertion of the study lenses. Lens performance was assessed by eye for the following parameters: burning/stinging upon insertion, comfort upon insertion, ease of handling/insertion, vision upon insertion, and lens cleanness upon insertion. As with symptoms/complaints, responses were on a scale from 0 to 100, with 0 being the most unfavorable score.

Outcome measures

Outcome measures
Measure	Experimental- Soflens n=426 eyes Bausch \& Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study	Marketed - Soflens n=424 eyes Bausch \& Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study.
Initial Lens Performance Survey Burning/stinging upon insertion	91.6 score on a scale Standard Deviation 18.7	91.0 score on a scale Standard Deviation 18.7
Initial Lens Performance Survey Comfort Upon Insertion	83.8 score on a scale Standard Deviation 21.1	83.9 score on a scale Standard Deviation 21.2
Initial Lens Performance Survey Ease of Handling/Insertion	77.2 score on a scale Standard Deviation 26.2	79.4 score on a scale Standard Deviation 26.3
Initial Lens Performance Survey Vision Upon Insertion	89.3 score on a scale Standard Deviation 15.5	88.4 score on a scale Standard Deviation 15.6
Initial Lens Performance Survey Lens Cleanness Upon Insertion	95.4 score on a scale Standard Deviation 10.8	94.9 score on a scale Standard Deviation 10.9

Adverse Events

Experimental- Soflens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Marketed - Soflens

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: 908-300-9920

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