NCT01309100

Brief Summary

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

April 29, 2014

Completed
Last Updated

April 29, 2014

Status Verified

March 1, 2014

Enrollment Period

1 month

First QC Date

March 3, 2011

Results QC Date

March 27, 2014

Last Update Submit

March 27, 2014

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

  • Visual Acuity (Investigational vs Air Optix Aqua Lens)

    The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.

    1 week

  • Visual Acuity (Investigational vs Acuvue Oasys Lens)

    The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.

    1 week

Secondary Outcomes (2)

  • Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)

    1 week

  • Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)

    1 week

Study Arms (3)

Investigational Lens

EXPERIMENTAL

Bausch \& Lomb investigational silicone hydrogel lens.

Device: Investigational Lens

Acuvue Oasys Lens

ACTIVE COMPARATOR

Johnson \& Johnson Acuvue Oasys contact lens.

Device: Acuvue Oasys Lens

Air Optix Aqua Lens

ACTIVE COMPARATOR

Ciba Vision Air Optix Aqua contact lens.

Device: Air Optix Aqua Lens

Interventions

Investigational LensDEVICE

Bausch \& Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.

Investigational Lens
Acuvue Oasys LensDEVICE

Johnson \& Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.

Acuvue Oasys Lens
Air Optix Aqua LensDEVICE

Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.

Air Optix Aqua Lens

Eligibility Criteria

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

You may qualify if:

  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
  • Subjects must be myopic and require lens correction

You may not qualify if:

  • Subjects with any systemic disease affecting ocular health.
  • Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Subjects with an active ocular disease or are using any ocular medication.
  • Subjects with 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 (1)

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Dr. Robert Steffen
Organization
Bausch & Lomb
robert.steffen@bausch.com
585 338 6399

Study Officials

  • Tara Vaz, OD

    Bausch & Lomb Incorporated

    PRINCIPAL INVESTIGATOR

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
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2011

First Posted

March 4, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2011

Last Updated

April 29, 2014

Results First Posted

April 29, 2014

Record last verified: 2014-03

Locations

US(1)