Trial Outcomes & Findings for Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses (NCT NCT01118338)

Last Updated: 2020-10-06

Results Overview

Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.

Recruitment status

COMPLETED

Study phase

Target enrollment

376 participants

Primary outcome timeframe

1 month

Results posted on

2020-10-06

Participant Flow

There were 188 participants enrolled into each group, for a total of 376 participants enrolled. There were 185 participants in the redesigned group and 183 participants in the control group who were eligible and dispensed lenses.

Participant milestones

Participant milestones
Measure	Redesigned Purevision Contact Lens Redesigned Bausch \& Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	PureVision Contact Lens Bausch \& Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Overall Study STARTED	185	183
Overall Study COMPLETED	182	174
Overall Study NOT COMPLETED	3	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Redesigned Purevision Contact Lens n=185 Participants Redesigned Bausch \& Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	PureVision Contact Lens n=183 Participants Bausch \& Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	Total n=368 Participants Total of all reporting groups
Age, Continuous	32.0 years n=5 Participants	30.6 years n=7 Participants	31.3 years n=5 Participants
Sex: Female, Male Female	136 Participants n=5 Participants	130 Participants n=7 Participants	266 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	53 Participants n=7 Participants	102 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month

Population: There were 185 participants (370 eyes) in the redesigned group and 183 participants (366 eyes) in the control group who were eligible and dispensed lenses. There were 368 dispensed eyes in the redesigned group and 360 dispensed eyes in the control group evaluable for the analysis population for the assessment of symptoms and complaints.

Outcome measures

Outcome measures
Measure	Redesigned Purevision Contact Lens n=368 eyes Redesigned Bausch \& Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	PureVision Contact Lens n=360 eyes Bausch \& Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Symptoms and Complaints Comfort upon insertion	78.1 score on a scale Standard Deviation 21.7	74.6 score on a scale Standard Deviation 21.7
Symptoms and Complaints Burning/stinging upon insertion	84.6 score on a scale Standard Deviation 19.0	83.2 score on a scale Standard Deviation 19.0
Symptoms and Complaints Comfort throughout the day	75.1 score on a scale Standard Deviation 22.2	73.0 score on a scale Standard Deviation 22.2
Symptoms and Complaints Lens cleanliness	84.5 score on a scale Standard Deviation 16.5	81.5 score on a scale Standard Deviation 16.5
Symptoms and Complaints Irritation	76.6 score on a scale Standard Deviation 22.4	73.4 score on a scale Standard Deviation 22.4
Symptoms and Complaints Itching	85.7 score on a scale Standard Deviation 18.5	85.2 score on a scale Standard Deviation 18.5
Symptoms and Complaints Dryness	75.1 score on a scale Standard Deviation 23.8	73.5 score on a scale Standard Deviation 23.9
Symptoms and Complaints Lens handling upon insertion	83.2 score on a scale Standard Deviation 17.7	83.6 score on a scale Standard Deviation 17.7
Symptoms and Complaints End of day comfort	67.6 score on a scale Standard Deviation 24.8	65.1 score on a scale Standard Deviation 24.9
Symptoms and Complaints Lens awareness	76.4 score on a scale Standard Deviation 22.6	72.1 score on a scale Standard Deviation 22.6
Symptoms and Complaints Redness	88.5 score on a scale Standard Deviation 17.6	86.6 score on a scale Standard Deviation 17.6
Symptoms and Complaints Vision	82.9 score on a scale Standard Deviation 19.7	82.0 score on a scale Standard Deviation 19.7
Symptoms and Complaints Lens handling upon removal	88.3 score on a scale Standard Deviation 15.5	86.6 score on a scale Standard Deviation 15.5
Symptoms and Complaints Overall impression	72.8 score on a scale Standard Deviation 24.7	67.7 score on a scale Standard Deviation 24.7

SECONDARY outcome

Timeframe: 1 month

Population: There were 185 participants (370 eyes) in the redesigned group and 183 participants (366 eyes) in the control group who were eligible and dispensed lenses.

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

Outcome measures

Outcome measures
Measure	Redesigned Purevision Contact Lens n=370 eyes Redesigned Bausch \& Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	PureVision Contact Lens n=366 eyes Bausch \& Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Visual Acuity	-0.028 logMAR Standard Deviation 0.068	-0.021 logMAR Standard Deviation 0.068

SECONDARY outcome

Timeframe: 1 month

Population: There were 188 participants (376 eyes) enrolled into each group, for a total of 376 participants enrolled (752 eyes). There were 372 eyes in the redesigned group and 374 eyes in the control group assessed for slit lamp findings during the study.

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	Redesigned Purevision Contact Lens n=372 eyes Redesigned Bausch \& Lomb PureVision contact lens Redesigned Purevision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.	PureVision Contact Lens n=374 eyes Bausch \& Lomb PureVision contact lens PureVision Contact Lens: Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
Percentage of Eyes With > Grade 2 Slit Lamp Findings	5 eyes	5 eyes

Adverse Events

Redesigned Purevision Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PureVision Contact Lens

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