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CompletedNCT03603600Updated Dec 24, 2024Results posted

Evaluate the Safety and Effectiveness of the enVista® One-Piece Hydrophobic Acrylic Trifocal Intraocular Lens

An interventional study of enVista MX60E and enVista MX60EF in Cataract, sponsored by Bausch & Lomb Incorporated. Completed at 23 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-24.

Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
501
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study summary

The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.

Read the detailed description

Cataracts are a common condition in adults over 40 years of age, and surgical replacement of the cataractous lens with an intraocular lens (IOL) remains an effective way to restore vision to cataract patients.The objective of the study is to evaluate the safety and effectiveness of the enVista trifocal intraocular lens when implanted in the capsular bag.

02

Conditions studied

  • Cataract

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03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 501 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Subjects must be 22 years of age or older on the date the Informed Consent Form (ICF) is signed.
  2. Subjects must have the capability to understand and provide written informed consent on the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and authorization as appropriate for local privacy regulations.
  3. Subjects must have a BCDVA equal to or worse than 20/40 in each eye, with or without a glare source, due to a clinically significant cataract (cortical, nuclear, subcapsular, or combination) that is considered amenable to treatment with standard phacoemulsification cataract extraction and capsular IOL implantation.
  4. Subjects must have a BCDVA projected to be better than 20/32 after IOL implantation in each eye, as determined by the medical judgment of the Investigator or measured by potential acuity meter (PAM) testing, if necessary.
  5. Subjects must have clear intraocular media other than the cataract in both eyes.
  6. Contact lens wearers must demonstrate a stable refraction (within ±0.50 D for both sphere and cylinder) in both eyes, as determined by distance manifest refraction on two consecutive examination dates after discontinuation of contact lens wear.
  7. Subjects must require an IOL power from +16.0 diopter (D) to +24.0 D in both eyes.
  8. Subjects must be willing and able to comply with all treatment and follow-up study visits and procedures, and to undergo second eye surgery within 7-30 days of the first eye surgery.

Exclusion criteria

Exclusion Criteria:

  1. Subjects who have used an investigational drug or device within 30 days prior to entry into this study and/or will participate in another investigation during the period of study participation.
  2. Subjects who have any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in either eye.
  3. Subjects who have significant anterior segment pathology that might increase intraoperative risk or compromise IOL stability (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, traumatic cataract, lens subluxation, traumatic zonulolysis, zonular dialysis, evident zonular weakness or dehiscence, hypermature or brunescent cataract, etc.) in either eye.
  4. Subjects who have uncontrolled glaucoma in either eye.
  5. Subjects who have previous retinal detachment or clinically significant retinal pathology involving the macula in either eye.
  6. Subjects who have proliferative or non-proliferative diabetic retinopathy in either eye.
  7. Subjects who have a congenital ocular anomaly (e.g., aniridia, congenital cataract) in either eye.
  8. Subjects using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure within 30 days of enrollment or during the study (refer to the relevant attachment of the Study Reference Manual).
  9. Subjects who have a history of chronic or recurrent inflammatory eye disease (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis) in either eye.
  10. Subjects who have a visual disorder, other than cataracts, that could potentially cause future acuity losses to a level of 20/100 or worse in either eye.
  11. Subjects who have had previous intraocular or corneal surgery in either eye, with the exception of laser trabeculoplasty.
  12. Subjects with any preoperative infectious conjunctivitis, keratitis, or uveitis in either eye.
  13. Subjects who have a preoperative corneal astigmatism > 1.0 D in either eye, irregular astigmatism, or skewed radial axis (note: corneal incisions intended specifically to reduce astigmatism are not allowed during the study).
  14. Subjects who cannot achieve a minimum pharmacologic pupil dilation of 5.0 mm in both eyes.
  15. Subjects who may be expected to require a combined or other secondary surgical procedure in either eye.
  16. Subjects who during the first cataract extraction experience an anterior or posterior capsule tear or rupture, zonular dialysis, significant iris trauma, or other complication that may cause untoward effects in the judgment of the Investigator.
  17. Females of childbearing potential (those who are not surgically sterilized or at least 12 months postmenopausal) are excluded from enrollment in the study if they are currently pregnant or plan to become pregnant during the study. Females of childbearing potential must be willing to practice effective contraception for the duration of the study.
  18. Subjects with any other serious ocular pathology or underlying systemic medical condition (e.g., uncontrolled diabetes) or circumstance that, based on the Investigator's judgment, poses a concern for the subjects' safety or could confound the results of the study.
  19. Subjects who have current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g., Flomax® (tamsulosin HCl), Terazosin, or Cardura).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
501 participants (actual)

Study arms

  • Experimental
    enVista MX60EF

    enVista MX60EF (trifocal) multifocal IOL (MIOL)

    Device: enVista MX60EF

  • Active comparator
    enVista MX60E

    enVista MX60E monofocal IOL

    Device: enVista MX60E

Interventions

  • DeviceenVista MX60E

    enVista MX60E monofocal IOL

  • DeviceenVista MX60EF

    enVista MX60EF (trifocal) multifocal IOL (MIOL)

06

What researchers measure

Primary outcomes

  1. Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA)

    Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation)

    Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  2. Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA)

    Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)

    Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  3. Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA)

    Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first eyes at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation

    Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  4. Serious Adverse Events

    All ocular SAEs, including secondary surgical interventions (SSIs) related to the optical properties of the IOL, in first eyes through study exit

    Time frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline

  5. The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit

    The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes.

    Time frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline

  6. The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint

    The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes

    Time frame: Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline

Secondary outcomes

  1. Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4

    Photopic binocular distance-corrected near visual acuity (DCNVA) at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)

    Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  2. Photopic Binocular UNVA at 40 cm at Postoperative Visit 4

    Photopic binocular uncorrected near visual acuity (UNVA) at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)

    Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  3. Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4

    Photopic binocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)

    Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  4. Photopic Binocular UIVA at 66 cm at Postoperative Visit 4

    Photopic binocular uncorrected intermediate visual acuity (UIVA) at 66 cm at Postoperative Visit 4 (Day 120 to Day 180 after second eye implantation)

    Time frame: Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.

  5. First-eye BCDVA Evaluated at Postoperative Visit 5

    First-eye BCDVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)

    Time frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline

  6. First-eye DCNVA Evaluated at Postoperative Visit 5

    First-eye DCNVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)

    Time frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline

  7. First-eye DCIVA Evaluated at Postoperative Visit 5

    First-eye DCIVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)

    Time frame: Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline

07

Results

Posted Dec 24, 2024

Participant flow

Participant flow — Overall Study
MilestoneenVista MX60EFenVista MX60E
Started332169
Completed319157
Not completed1312
Withdrew: Withdrawal by subject57
Withdrew: Lost to follow-up23
Withdrew: Death31
Withdrew: Physician decision21
Withdrew: Other reason10

Outcome measures

PrimaryPhotopic Monocular Best-corrected Distance Visual Acuity (BCDVA)

Photopic monocular best-corrected distance visual acuity (BCDVA) in first eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation eyes at Post-Operative Visit 4 (Day 120 to 180 after second eye implantation)

Time frame:
Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Reported as:
Mean · logMAR
Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA)
logMARenVista MX60EFenVista MX60E
Photopic Monocular Best-corrected Distance Visual Acuity (BCDVA)0.022 ± 0.0950-0.017 ± 0.0897
PrimaryPhotopic Monocular Distance-corrected Near Visual Acuity (DCNVA)

Photopic monocular distance-corrected near visual acuity (DCNVA) in first eyes at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)

Time frame:
Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Reported as:
Mean · logMAR
Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA)
logMARenVista MX60EFenVista MX60E
Photopic Monocular Distance-corrected Near Visual Acuity (DCNVA)0.152 ± 0.13420.545 ± 0.1703
PrimaryPhotopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA)

Photopic monocular distance-corrected intermediate visual acuity (DCIVA) in first eyes at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation

Time frame:
Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Reported as:
Mean · logMAR
Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA)
logMARenVista MX60EFenVista MX60E
Photopic Monocular Distance-corrected Intermediate Visual Acuity (DCIVA)0.122 ± 0.11990.349 ± 0.1592
PrimarySerious Adverse Events

All ocular SAEs, including secondary surgical interventions (SSIs) related to the optical properties of the IOL, in first eyes through study exit

Time frame:
Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Reported as:
Count of participants · Participants
Serious Adverse Events
ParticipantsenVista MX60EFenVista MX60E
Macular hole10
Retinal tear10
Retinal vein occlusion10
Ophthalmic herpes zoster01
Seidel test positive10
PrimaryThe Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit

The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes.

Time frame:
Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Reported as:
Number · first eyes
The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit
first eyesenVista MX60EFenVista MX60E
The Rate of SSIs Due to the Optical Properties of the Lens for First Eyes Through Study Exit00
PrimaryThe Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint

The cumulative rate of secondary surgical interventions (SSI) due to the optical properties of the lens for first eyes through study exit. The rate was determined as the number of first eyes with an SSI related to the optical properties of the IOL divided by the total number of first eyes

Time frame:
Assessed through study exit, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline
Reported as:
Number · first eyes
The Incidence of AEs in First Eyes Compared to ISO Safety and Performance Endpoint
first eyesenVista MX60EF
Cystoid macular oedema0
Hypopyon0
Endophthalmitis0
Lens dislocated from posterior chamber0
Pupillary block0
Retinal detachment0
SSI0
SecondaryPhotopic Binocular DCNVA at 40 cm at Postoperative Visit 4

Photopic binocular distance-corrected near visual acuity (DCNVA) at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)

Time frame:
Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Reported as:
Mean · logMAR
Photopic Binocular DCNVA at 40 cm at Postoperative Visit 4
logMARenVista MX60EFenVista MX60E
Photopic Binocular DCNVA at 40 cm at Postoperative Visit 40.080 ± 0.09770.453 ± 0.1526
SecondaryPhotopic Binocular UNVA at 40 cm at Postoperative Visit 4

Photopic binocular uncorrected near visual acuity (UNVA) at 40 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)

Time frame:
Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Reported as:
Mean · logMAR
Photopic Binocular UNVA at 40 cm at Postoperative Visit 4
logMARenVista MX60EFenVista MX60E
Photopic Binocular UNVA at 40 cm at Postoperative Visit 40.096 ± 0.10560.418 ± 0.1454
SecondaryPhotopic Binocular DCIVA at 66 cm at Postoperative Visit 4

Photopic binocular distance-corrected intermediate visual acuity (DCIVA) at 66 cm at Post-Operative Visit 4 (Day 120 to 180 after second eye IOL implantation)

Time frame:
Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Reported as:
Mean · logMAR
Photopic Binocular DCIVA at 66 cm at Postoperative Visit 4
logMARenVista MX60EFenVista MX60E
Photopic Binocular DCIVA at 66 cm at Postoperative Visit 40.041 ± 0.09760.268 ± 0.1485
SecondaryPhotopic Binocular UIVA at 66 cm at Postoperative Visit 4

Photopic binocular uncorrected intermediate visual acuity (UIVA) at 66 cm at Postoperative Visit 4 (Day 120 to Day 180 after second eye implantation)

Time frame:
Day 120 to Day 180 after second eye implantation, up to 210 days from first eye implantation at Baseline.
Reported as:
Mean · logMAR
Photopic Binocular UIVA at 66 cm at Postoperative Visit 4
logMARenVista MX60EFenVista MX60E
Photopic Binocular UIVA at 66 cm at Postoperative Visit 40.064 ± 0.09880.217 ± 0.1442
SecondaryFirst-eye BCDVA Evaluated at Postoperative Visit 5

First-eye BCDVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)

Time frame:
Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
Reported as:
Mean · logMAR
First-eye BCDVA Evaluated at Postoperative Visit 5
logMARenVista MX60EFenVista MX60E
First-eye BCDVA Evaluated at Postoperative Visit 50.027 ± 0.0920-0.020 ± 0.0826
SecondaryFirst-eye DCNVA Evaluated at Postoperative Visit 5

First-eye DCNVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)

Time frame:
Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
Reported as:
Mean · logMAR
First-eye DCNVA Evaluated at Postoperative Visit 5
logMARenVista MX60EFenVista MX60E
First-eye DCNVA Evaluated at Postoperative Visit 50.143 ± 0.12840.533 ± 0.1843
SecondaryFirst-eye DCIVA Evaluated at Postoperative Visit 5

First-eye DCIVA evaluated at Postoperative Visit 5 (Day 330 to Day 420 after second eye implantation)

Time frame:
Day 330 to Day 420 after second eye implantation, up to 450 days from first eye implantation at baseline
Reported as:
Mean · logMAR
First-eye DCIVA Evaluated at Postoperative Visit 5
logMARenVista MX60EFenVista MX60E
First-eye DCIVA Evaluated at Postoperative Visit 50.120 ± 0.11470.343 ± 0.1594

Adverse events

Collected over Through study completion, 330 - 450 days after second eye implantation, up to 480 days from first eye implantation at baseline. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
enVista MX60EF3/332 (0.9%)17/332 (5.1%)120/332 (36.1%)
enVista MX60E1/169 (0.6%)15/169 (8.9%)47/169 (27.8%)
Most frequent serious events
Showing 10 of 29
Most frequent serious events
EventenVista MX60EFenVista MX60E
Cerebrovascular accidentNervous system disorders2/3322/169
Chest painGeneral disorders0/3322/169
Ophthalmic herpes zosterInfections and infestations0/3321/169
Cataract operation complicationInjury, poisoning and procedural complications0/3321/169
PresyncopeNervous system disorders0/3321/169
Transient ischaemic attackNervous system disorders0/3321/169
Benign neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/3321/169
Breast cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/3321/169
Multiple organ dysfunction syndromeEye disorders0/3321/169
CellulitisInfections and infestations0/3321/169
Most frequent other events
Most frequent other events
EventenVista MX60EFenVista MX60E
Punctate keratitisEye disorders57/33216/169
Intraocular pressure increasedInvestigations43/33221/169
Vitreous detachmentEye disorders32/33212/169

Baseline characteristics

Age, Continuous
Age, Continuous(years)enVista MX60EFenVista MX60ETotal
Mean67.6 ± 7.8968.8 ± 7.4668.0 ± 7.76
Sex: Female, Male
Sex: Female, Male(Participants)enVista MX60EFenVista MX60ETotal
Female212108320
Male12061181
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)enVista MX60EFenVista MX60ETotal
Hispanic or Latino402060
Not Hispanic or Latino292149441
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)enVista MX60EFenVista MX60ETotal
American Indian or Alaska Native000
Asian11415
Native Hawaiian or Other Pacific Islander101
Black or African American14923
White305156461
More than one race101
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)enVista MX60EFenVista MX60ETotal
United States322169501
08

Study locations

23 sites
  • Bausch Site 108
    Fayetteville, Arkansas 72703, United States
  • Bausch Site 113
    Garden Grove, California 02843, United States
  • Bausch Site 120
    Northridge, California 91325, United States
  • Bausch Site 115
    Redding, California 96002, United States
  • Bausch Site 103
    Torrance, California 90505, United States
  • Bausch Site 107
    Mount Dora, Florida 32757, United States
  • Bausch Site 117
    Lake Villa, Illinois 60046, United States
  • Bausch Site 101
    Bloomington, Minnesota 55420, United States
  • Bausch Site 119
    Birmingham, Mississippi 49009, United States
  • Bausch Site 102
    Saint Louis, Missouri 63131, United States
  • Bausch Site 124
    Omaha, Nebraska 68137, United States
  • Bausch Site 118
    Las Vegas, Nevada 89145, United States
  • Bausch Site 106
    Brecksville, Ohio 44141, United States
  • Bausch Site 109
    Columbus, Ohio 43215, United States
  • Bausch Site 116
    Pittsburgh, Pennsylvania 16066, United States
  • Bausch Site 121
    Sioux Falls, South Dakota 57108, United States
  • Bausch Site 112
    Memphis, Tennessee 38119, United States
  • Bausch Site 110
    Nashville, Tennessee 37205, United States
  • Bausch Site 104
    Cedar Park, Texas 78613, United States
  • Bausch Site 105
    Dallas, Texas 75243, United States
  • Bausch Site 111
    Houston, Texas 77008, United States
  • Bausch Site 122
    San Antonio, Texas 78215, United States
  • Bausch Site 123
    San Antonio, Texas 78229, United States
09

References and documents

Study documents

  • Study protocol · Apr 24, 2023
  • Statistical analysis plan · Jun 1, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03603600
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
Jul 27, 2018
Start date
May 31, 2018
Primary completion
May 4, 2023
Completion
May 4, 2023
Results posted
Dec 24, 2024
Last update
Dec 24, 2024

Study contacts

Rosangela Nolasco
study director · Bausch & Lomb Incorporated

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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