NCT00754338

Brief Summary

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

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

January 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 20, 2010

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

September 17, 2008

Results QC Date

March 26, 2010

Last Update Submit

September 21, 2023

Conditions

Ametropia

Keywords

comfortwetabilityprotein depositlipid deposit

Outcome Measures

Primary Outcomes (3)

  • Comfort

    Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'.

    4 weeks

  • Lens Wettability

    Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced).

    4 weeks

  • Lens Deposits

    Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits).

    4 weeks

Secondary Outcomes (3)

  • Dryness

    4 weeks

  • Subjective Vision

    4 weeks

  • Corneal Staining

    4 weeks

Study Arms (4)

Phase1 - Arm 1

ACTIVE COMPARATOR
Drug: Alcon Opti-Free® RepleniSH® with Supraclens®Drug: Alcon Opti-Free® RepleniSH®

Phase1 - Arm 2

ACTIVE COMPARATOR
Drug: Alcon Opti-Free® RepleniSH® with Supraclens®Drug: Alcon Opti-Free® RepleniSH®

Phase 2 - Arm 1

ACTIVE COMPARATOR
Drug: Alcon Opti-Free® RepleniSH® with Supraclens®Drug: B&L ReNu MultiPlus™

Phase 2 - Arm 2

ACTIVE COMPARATOR
Drug: Alcon Opti-Free® RepleniSH® with Supraclens®Drug: B&L ReNu MultiPlus™

Interventions

Alcon Opti-Free® RepleniSH® with Supraclens®DRUG

Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover

Phase 2 - Arm 1Phase 2 - Arm 2Phase1 - Arm 1Phase1 - Arm 2
Alcon Opti-Free® RepleniSH®DRUG

Marketed Multipurpose Disinfecting Care System

Phase1 - Arm 1Phase1 - Arm 2
B&L ReNu MultiPlus™DRUG

Marketed Multipurpose Disinfecting Care Systems

Phase 2 - Arm 1Phase 2 - Arm 2

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Is at least 17 years of age and has full legal capacity to volunteer.
  • Has read, understood and signed an information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
  • Has clear corneas and no active ocular disease.
  • Has had an ocular examination in the last two years.
  • Is a current soft lens wearer, replacing their lenses every two weeks to one month.
  • Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.
  • Has astigmatism less than or equal to -1.00 DC.

You may not qualify if:

  • Has any signs or symptoms of dry eye.
  • Has any clinically significant blepharitis.
  • Has undergone corneal refractive surgery.
  • Is aphakic.
  • Has any active ocular disease.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that may affect ocular health.
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
  • Is pregnant or lactating.
  • Is participating in any other type of clinical or research study.
  • Currently wears daily disposable lenses.
  • Currently wears lenses on an extended wear basis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Contact Lens Research, School of Optometry, University of Waterloo.

Waterloo, Ontario, N2L3G1, Canada

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Craig A Woods, Research Manager
Organization
Centre for Contact Lens Research
cawoods@sciborg.uwaterloo.ca
1 519 888 4567

Study Officials

  • Desmond Fonn, MOptom

    University of Waterloo

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

September 28, 2023

Results First Posted

September 20, 2010

Record last verified: 2023-09

Locations

CA(1)