FindTrial
Sign In

Comparative Performance of PureVision Lens Designs

A Study to Evaluate the Product Performance of the Redesigned Bausch & Lomb PureVision® Contact Lens (Test) Compared to the Currently Marketed Bausch & Lomb PureVision® Contact Lens (Control) When Worn on an Extended Wear Basis.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00661687
Enrollment
206
Registered
2008-04-18
Start date
2007-12-31
Completion date
2008-06-30
Last updated
2011-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief summary

The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis

Interventions

DEVICECurrently Marketed PureVision Contact Lens.

Contact lens for continuous wear

DEVICEAlternate Design of the PureVision Contact Lens.

Contact lens for continuous wear

Sponsors

Bausch & Lomb Incorporated
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* subject is myopic * VA correctable to 0.3 logMAR or better (driving vision) * Clear central cornea

Exclusion criteria

* Systemic disease affecting ocular health * using systemic or topical medications * wear monovision, multifocal or toric contact lenses * Any grade 2 or greater slit lamp findings

Design outcomes

Primary

MeasureTime frameDescription
Subjective Responses to Symptoms/ComplaintsMeasured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visitsSubjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.

Secondary

MeasureTime frameDescription
LogMAR Visual AcuityMean over all visits - 1 day, 1 week, 1 monthThe mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.
Lens CharacteristicsOver all scheduled visits day 1 - 1 monthInvestigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.

Countries

Malaysia, Philippines

Participant flow

Recruitment details

Recruitment began on 12/24/07 and lasted for 1 month. Participants were recruited from 10 Asian Sites.

Pre-assignment details

206 participants were enrolled. 204 participants were eligible and 189 completed the study. Study was a contralateral design with one eye of each patient randomly assigned to the experimental group and fellow eye to the control group.

Participants by arm

ArmCount
PureVision Contact Lens
PureVision Contact Lens Original Design and New Design.
204
Total204

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event2
Overall StudyInability to maintain wearing schedule3
Overall StudyPhysician Decision1
Overall StudyPositive slit lamp findings4
Overall StudyStudy related symptoms and complaints5

Baseline characteristics

CharacteristicPureVision Contact Lens
Age Continuous28.1 Years
STANDARD_DEVIATION 6.97
Race/Ethnicity, Customized
Asian
203 Participants
Race/Ethnicity, Customized
White
1 Participants
Sex: Female, Male
Female
130 Participants
Sex: Female, Male
Male
74 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 2040 / 204
serious
Total, serious adverse events
0 / 2040 / 204

Outcome results

Primary

Subjective Responses to Symptoms/Complaints

Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint.

Time frame: Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits

Population: All eligible participants

ArmMeasureValue (MEAN)Dispersion
PureVision Contact Lens Design #1Subjective Responses to Symptoms/Complaints80.0 Visual Analogue ScaleStandard Deviation 15.07
PureVision Contact Lens Design #2Subjective Responses to Symptoms/Complaints81.2 Visual Analogue ScaleStandard Deviation 14.52
Secondary

Lens Characteristics

Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement.

Time frame: Over all scheduled visits day 1 - 1 month

Population: Over All Scheduled Visits, All Eligible, Dispensed Eyes

ArmMeasureGroupValue (NUMBER)
PureVision Contact Lens Design #1Lens CharacteristicsLens discoloration - absent182 Eyes
PureVision Contact Lens Design #1Lens CharacteristicsLens centration - excellent171 Eyes
PureVision Contact Lens Design #1Lens CharacteristicsSuboptimal lens deposits (medium/heavy) - absent181 Eyes
PureVision Contact Lens Design #1Lens CharacteristicsLens movement - adequate138 Eyes
PureVision Contact Lens Design #1Lens CharacteristicsLens wettability - 100% of anterior surface75 Eyes
PureVision Contact Lens Design #2Lens CharacteristicsLens movement - adequate138 Eyes
PureVision Contact Lens Design #2Lens CharacteristicsLens wettability - 100% of anterior surface78 Eyes
PureVision Contact Lens Design #2Lens CharacteristicsLens discoloration - absent182 Eyes
PureVision Contact Lens Design #2Lens CharacteristicsSuboptimal lens deposits (medium/heavy) - absent179 Eyes
PureVision Contact Lens Design #2Lens CharacteristicsLens centration - excellent164 Eyes
Secondary

LogMAR Visual Acuity

The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart.

Time frame: Mean over all visits - 1 day, 1 week, 1 month

Population: All Eligible, Dispensed Eyes

ArmMeasureValue (MEAN)Dispersion
PureVision Contact Lens Design #1LogMAR Visual Acuity0.001 LogMARStandard Deviation 0.0678
PureVision Contact Lens Design #2LogMAR Visual Acuity0.003 LogMARStandard Deviation 0.0673

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026