NCT03681808

Brief Summary

Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 17, 2020

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

September 20, 2018

Results QC Date

November 23, 2020

Last Update Submit

January 6, 2021

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

  • Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better

    The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes

    Evaluated at the 1 week follow up visit

Study Arms (2)

Test

EXPERIMENTAL

Soft Contact Lens

Device: Test

Control

ACTIVE COMPARATOR

Contact lens

Device: Control

Interventions

ControlDEVICE

Contact Lens

Control
TestDEVICE

Soft Contact Lens

Test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be of legal age (at least 18 or as defined by state law) on the date the ICF is signed and have the capacity to provide voluntary informed consent.
  • Subject must be able to read, understand and provide written informed consent on the IRB approved ICF and provide authorization as appropriate for local privacy regulations.
  • Subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than Grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas.
  • Subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

You may not qualify if:

  • Subject has worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
  • Subject has systemic disease affecting ocular health.
  • Subject is using any systemic or topical medications that will affect ocular physiology or lens performance.
  • Subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.
  • Subject has any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Bausch Site 117

Irvine, California, 92618, United States

Location

Bausch Site 107

San Diego, California, 92123, United States

Location

Bausch Site 101

San Francisco, California, 94112, United States

Location

Bausch Site 108

San Jose, California, 95132, United States

Location

Bausch Site 104

Sunnyvale, California, 94087, United States

Location

Bausch Site 102

Jacksonville, Florida, 32250, United States

Location

Bausch Site 116

Bloomington, Illinois, 61701, United States

Location

Bausch Site 110

Brighton, New York, 14618, United States

Location

Bausch Site 118

New York, New York, 10022, United States

Location

Bausch Site 111

New York, New York, 10036, United States

Location

Bausch Site 114

Raleigh, North Carolina, 27603, United States

Location

Bausch Site 105

Houston, Texas, 77204, United States

Location

Bausch Site 115

Issaquah, Washington, 98027, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Study Director
Organization
Bausch & Lomb
Robert.Steffen@bausch.com
585-338-6399

Study Officials

  • Lindsey Mathew

    Bausch Health Companies

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Subjects will be dispensed product according to the treatment arm corresponding to their randomization and will be unmasked. The Investigator will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Investigator/Sponsor masked, randomized, open-label, parallel-group, multicenter study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 24, 2018

Study Start

October 10, 2018

Primary Completion

December 16, 2019

Study Completion

December 16, 2019

Last Updated

January 8, 2021

Results First Posted

December 17, 2020

Record last verified: 2021-01

Locations

US(13)