Trials Sponsors Conditions Drugs Pricing

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®

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

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.

Sponsors & Collaborators

Alcon Research
Industrycollaborator
University of Waterloo
Otherlead

Study Sites (1)

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

Waterloo, Ontario, N2L3G1, Canada

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

Study Officials

Desmond Fonn, MOptom
University of Waterloo
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Enrollment

76 participants (actual enrollment reported by the registry).

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 2008

Date type not reported

This date has not been verified as actual or estimated.

Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (4)

Phase1 - Arm 1

Phase1 - Arm 2

Phase 2 - Arm 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Phase 2 - Arm 2

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (3)

Study Arms (4)

Phase1 - Arm 1

Phase1 - Arm 2

Phase 2 - Arm 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Phase 2 - Arm 2

You may not qualify if:

Source record

Locations