A Pilot Study on the Use of a Sensory Panel to Assess Comfort Between Three Different Contact Lenses

NCT01840787 | Completed

• 1 other identifier: 18801
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

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.

Also known as: Bausch & Lomb PureVision 8.3

Contralateral lens comfort comparisons

senofilcon A DEVICE

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

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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;
• 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.

Sponsors & Collaborators

• University of Waterloo: lead
• Alcon Research: collaborator

Study Sites (1)

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

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Trefford Simpson, DipOptom

  University of Waterloo School of Optometry & Vision Science

  PRINCIPAL INVESTIGATOR

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 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

CA (1)