NCT01840787

Completed

A Pilot Study on the Use of a Sensory Panel to Assess Comfor...

University of Waterloo Source

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Other study identifiers

Sponsor study identifier

18801

Study Type

interventional

Actual enrollment (reported)

63

Locations

1 country

Sites

1

Timeline

Study Start

April 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

January 2014

Actual (reported)

Study Completion

January 2014

Actual (reported)

Brief Summary

As new contact lens products continue to be developed and improved, it's becoming harder for some individuals to tell whether one product is different from another. In addition, not everyone has the same level of sensitivity of their eyes, making it difficult for these judgments to be made. The purpose of this study is to explore the idea of using a pre-determined "expert panel" of individuals who are able to tell differences between contact lenses based on their comfort.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 63 participants
Study completion date: January 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2013
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
April 19, 2013
Actual (reported)
First Posted
April 26, 2013
Actual (reported)
Primary Completion
January 2014
Actual (reported)
Study Completion
January 2014
Actual (reported)

Last Updated: December 16, 2015
Status Verified: December 2015
Last Update Submitted: December 15, 2015

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

Change in eye comfort ratings
Prior to, and after lens insertion in the morning, and then again 8 hours later.

Study Arms (1)

Contralateral lens comfort comparisons

EXPERIMENTAL

Subjects will be randomized into receiving balafilcon A (8.3), or balafilcon A (8.6), or senofilcon A in one eye, and balafilcon A (8.3), or balafilcon A (8.6), or senofilcon A in the other eye.

Device: balafilcon A (8.6)Device: balafilcon A (8.3)Device: senofilcon A

Interventions

balafilcon A (8.6)Device

To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.

Also known as: Bausch & Lomb PureVision 8.6

Contralateral lens comfort comparisons

balafilcon A (8.3)Device

To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.

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 and signed an information consent letter;

Sponsors & Collaborators

Alcon Research
Industrycollaborator
University of Waterloo
Otherlead

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science

Waterloo, Ontario, N2L 3G1, Canada

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

Trefford Simpson, DipOptom
University of Waterloo School of Optometry & Vision Science
PRINCIPAL INVESTIGATOR

Enrollment

63 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: SINGLE
Who Masked: PARTICIPANT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 19, 2013

First Posted

April 26, 2013

Study Start

April 2013

Date type not reported

This date has not been verified as actual or estimated.

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NCT01957670

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Not ApplicableWithdrawn

NCT03467490

Self-care Management Program for Dry Eye Disease Patients Using the heiQ

Not ApplicableUnknown

Also known as:

Bausch & Lomb PureVision 8.3

Contralateral lens comfort comparisons

senofilcon ADevice

To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.

Also known as: Johnson & Johnson Acuvue Oasys

Contralateral lens comfort comparisons

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Is willing and able to follow instructions and maintain the appointment schedule;

Is an adapted soft contact lens wearer;

Has a contact lens prescription between +4.00 to -6.00D;

Has astigmatism \<= 1.00D;

Has vision of 20/40 or better in both eyes when wearing contact lenses

You may not qualify if:

Is participating in any concurrent clinical or research study;
Has any known active ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrolment, determined verbally;
Is aphakic;
Has undergone refractive surgery;
Is an employee of the Centre for Contact Lens Research;
Has anisometropia of \>=1.00D
Has a difference in comfort of 20 (on a 0-100 scale) between eyes when not wearing contact lenses.

Contact the study team to confirm eligibility.

Primary Completion

January 2014

Actual (reported)

Study Completion

January 2014

Actual (reported)

Last Updated

December 16, 2015

Record last verified: 2015-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01840787
Data provider: ClinicalTrials.gov
Source updated: 2015-12-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:13 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Contralateral lens comfort comparisons

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations