Dry Eye SyndromesNAISMITHNCT01840787
A Pilot Study on the Use of a Sensory Panel to Assess Comfort Between Three Different Contact Lenses
A study testing balafilcon A (8.6), balafilcon A (8.3) and senofilcon A in people with Dry Eye Syndromes, run by University of Waterloo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- balafilcon A (8.6), balafilcon A (8.3) and senofilcon A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science
Waterloo, Ontario, N2L 3G1
About this study
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.
Read the detailed description
As technology continues to advance, contact lenses and lens care products are becoming harder to differentiate. In addition, assessing comfort in clinical trials is complicated, with full-masking behind hard to achieve and the psychology of the participant having unknown impact on the results. While the development of a reliable system to assess comfort would be beneficial for the research and development of new products, the use of a "sensory panel" itself may also lead to a better understanding of the drivers of discomfort at the end of the day.
The objective of the study is to explore the use of a sensory panel, defined as individuals who have a good correlation between subjective and objective measures of discomfort, at rating the comfort of various contact lenses.
The hypothesis is that in the "discriminative" group, the matrix of paired comparisons (between lens dissimilarity) is related to the ranked comfort of the lenses, while for the "poorly discriminative" group, the matrix of the dissimilarities will be random. An additional hypothesis is that the "discriminative" group will be less random than the entire group.
- Conditions
- Dry Eye Syndromes
- Being tested
- balafilcon A (8.6), balafilcon A (8.3), senofilcon A
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balafilcon A (8.6)Device
Also called Bausch & Lomb PureVision 8.6
To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
balafilcon A (8.3)Device
Also called Bausch & Lomb PureVision 8.3
To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
senofilcon ADevice
Also called Johnson & Johnson Acuvue Oasys
To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: balafilcon A (8.6); Device: balafilcon A (8.3); Device: senofilcon A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eye comfort ratings
Measured: Prior to, and after lens insertion in the morning, and then again 8 hours later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Trefford Simpson, DipOptom, Principal investigator, University of Waterloo School of Optometry & Vision Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840787
- Sponsor's protocol ID
- 18801
- Acronym
- NAISMITH
- Status last verified
- Dec 2015
- First submitted
- 19 Apr 2013
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Use of a Sensory Panel to Assess Comfort Between Three Different Contact Lenses
- ClinicalTrials.gov ID
- NCT01840787
- Acronym / sponsor ID
- NAISMITH / 18801
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Apr 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As technology continues to advance, contact lenses and lens care products are becoming harder to differentiate. In addition, assessing comfort in clinical trials is complicated, with full-masking behind hard to achieve and the psychology of the participant having unknown impact on the results. While the development of a reliable system to assess comfort would be beneficial for the research and development of new products, the use of a "sensory panel" itself may also lead to a better understanding of the drivers of discomfort at the end of the day.
The objective of the study is to explore the use of a sensory panel, defined as individuals who have a good correlation between subjective and objective measures of discomfort, at rating the comfort of various contact lenses.
The hypothesis is that in the "discriminative" group, the matrix of paired comparisons (between lens dissimilarity) is related to the ranked comfort of the lenses, while for the "poorly discriminative" group, the matrix of the dissimilarities will be random. An additional hypothesis is that the "discriminative" group will be less random than the entire group.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contralateral lens comfort comparisons | Experimental | Device: balafilcon A (8.6), Device: balafilcon A (8.3), Device: senofilcon ASubjects 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. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| balafilcon A (8.6)Also: Bausch & Lomb PureVision 8.6To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye. | Device | Contralateral lens comfort comparisons |
| balafilcon A (8.3)Also: Bausch & Lomb PureVision 8.3To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye. | Device | Contralateral lens comfort comparisons |
| senofilcon AAlso: Johnson & Johnson Acuvue OasysTo be worn for 8 hours in one eye, and its comfort compared to another lens on another eye. | Device | Contralateral lens comfort comparisons |
Primary outcome
Change in eye comfort ratings
Time frame: Prior to, and after lens insertion in the morning, and then again 8 hours later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trefford Simpson, DipOptom principal investigator
University of Waterloo School of Optometry & Vision Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balafilcon A (8.6), balafilcon A (8.3) and senofilcon A in people with Dry Eye Syndromes, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eye comfort ratings (time frame: Prior to, and after lens insertion in the morning, and then again 8 hours later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.