NCT01318577

Brief Summary

The objective of this study is to evaluate the safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
444

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
5 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
9.4 years until next milestone

Results Posted

Study results publicly available

October 8, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

March 16, 2011

Results QC Date

August 21, 2020

Last Update Submit

October 5, 2020

Conditions

Vision Disorders

Keywords

Contact lensCleaning solution

Outcome Measures

Primary Outcomes (1)

  • Percentage of Eyes With > Grade 2 Slit Lamp Findings

    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.

    3 months

Study Arms (2)

Investigational Solution

EXPERIMENTAL

Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses.

Device: Investigational Cleaning & Disinfecting Solution

Clear Care Solution

ACTIVE COMPARATOR

Hydrogen peroxide system for cleaning, protein removal, disinfecting and storing of contact lenses

Device: Clear Care Solution

Interventions

Investigational Cleaning & Disinfecting SolutionDEVICE

Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution

Investigational Solution
Clear Care SolutionDEVICE

Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution

Clear Care Solution

Eligibility Criteria

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

You may qualify if:

  • Subjects must be habitual wearers of one of the protocol specified lenses.
  • Subjects must habitually use a NON-PEROXIDE lens care product for cleaning, disinfecting and storage of their lenses.
  • Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
  • Subjects must agree to wear their lenses on a daily wear basis for approximately three months.

You may not qualify if:

  • Subjects who currently use a hydrogen peroxide cleaning and disinfecting solution.
  • Subjects who currently wear Opaque Cosmetic Tint Contact Lenses.
  • Subjects who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
  • Subjects with any systemic disease currently affecting ocular health or which in the Investigator"s opinion may have an effect on ocular health during the course of the study.
  • Subjects using any systemic or topical medications that will, in the Investigator"s opinion, affect ocular physiology or lens performance.
  • Subjects with any "Present" finding during the slit lamp examination that, in the Investigator"s judgment, interferes with contact lens wear.
  • Subjects with any scar or neovascularization within the central 4 mm of the cornea.
  • Subjects who are allergic to any component in the study care products.

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

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Study Director
Organization
Bausch Health
robert.steffen@bausch.com
585-338-6399

Study Officials

  • Beverly Barna

    Bausch & Lomb Incorporated

    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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 18, 2011

Study Start

November 1, 2010

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

October 8, 2020

Results First Posted

October 8, 2020

Record last verified: 2020-10

Locations

US(1)