Back to resultsDaily Disposable Comparison Study
Primary Purpose
Myopia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
filcon II 3
etafilcon A
nelfilcon A
Sponsored by
About this trial
This is an interventional other trial for Myopia
Eligibility Criteria
Inclusion Criteria:
- 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 correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;
- Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.
- Demonstrates an acceptable fit with the study lenses
Exclusion Criteria:
- 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 (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery;
Sites / Locations
- Centre for Contact Lens Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
filcon II 3 and etafilcon A
filcon II 3 and nelfilcon A
Arm Description
Participants were randomized to a test and control lens for each group in a contralateral design.
Participants were randomized to a test and control lens for each group in a contralateral design.
Outcomes
Primary Outcome Measures
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire.
(5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Secondary Outcome Measures
Lens Comfort - Filcon II 3 and Etafilcon A
Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Lens Comfort - Filcon II 3 and Nelficon A
Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Lens Dryness - Filcon II 3 and Etafilcon A
Participant's subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).
Lens Dryness - Filcon II 3 and Nelfilcon A
Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).
Lens Handling - Filcon II 3 and Etafilcon A
Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).
Lens Handling - Filcon II 3 and Nelfilcon A
Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Lens Handling (Removal) - Filcon II 3 and Etafilcon A
Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Lens Handling (Removal) - Filcon II 3 and Nelfilcon A
Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Lens Wettability - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).
Lens Wettability - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).
Lens Fit, Centration - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I).
N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior
Lens Fit, Centration - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).
Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).
Lens Fit, Tightness - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).
Lens Fit, Tightness - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).
Lens Surface Deposition - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).
Lens Surface Deposition - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).
High Contrast Visual Acuity - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).
High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone).
N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone).
N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A
The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A
The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02094677
Brief Title
Daily Disposable Comparison Study
Official Title
Daily Disposable Comparison Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coopervision, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens.
Detailed Description
This was a two-day, randomized, non-dispensing, double-masked, contralateral study with two parallel groups. Participants were recruited into one of two groups - participants who habitually wore etafilcon A lens and participants who habitually wore nelfilcon A lens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
filcon II 3 and etafilcon A
Arm Type
Active Comparator
Arm Description
Participants were randomized to a test and control lens for each group in a contralateral design.
Arm Title
filcon II 3 and nelfilcon A
Arm Type
Active Comparator
Arm Description
Participants were randomized to a test and control lens for each group in a contralateral design.
Intervention Type
Device
Intervention Name(s)
filcon II 3
Other Intervention Name(s)
Hydrogel Daily Disposable Contact Lens
Intervention Description
Participants were randomized to wear filcon II 3 test lens.
Intervention Type
Device
Intervention Name(s)
etafilcon A
Other Intervention Name(s)
Hydrogel Daily Disposable Contact Lens, 1 Day Acuvue Moist
Intervention Description
Participants were randomized to wear etafilcon A control lens.
Intervention Type
Device
Intervention Name(s)
nelfilcon A
Other Intervention Name(s)
Hydrogel Daily Disposable Contact Lens, Dailies Aqua Comfort Plus
Intervention Description
Participants were randomized to wear nelfilcon A control lens.
Primary Outcome Measure Information:
Title
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Description
Participant's subjective response for lens preference of filcon II 3 and etafilcon A or filcon II 3 and nelfilcon A at baseline visit, following insertion, after settling 10-15mins (surveyed at baseline visit) rated by questionnaire.
(5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Time Frame
Baseline visit
Title
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Description
Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 3 hours lens wear rated by questionnaire. (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Time Frame
3 hours
Title
Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
Description
Participant's subjective response for lens preference of filcon II 3 and etafilcon A after 6 hours lens wear rated by questionnaire (5 possible ratings: Strongly prefer filcon II 3, Slightly prefer filcon II 3, No preference, Slightly prefer etafilcon A/nelfilcon A, Strongly prefer etafilcon A/nelfilcon A).
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Lens Comfort - Filcon II 3 and Etafilcon A
Description
Participant's subjective response for lens comfort of filcon II 3 and etafilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Time Frame
Baseline, 3 hours, 6 hours
Title
Lens Comfort - Filcon II 3 and Nelficon A
Description
Participant's subjective response for lens comfort of filcon II 3 and nelfilcon A after settling 10-15mins (surveyed at baseline visit, 3 hours, and 6 hours) rated by questionnaire (Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever).
Time Frame
Baseline, 3 hours, 6 hours
Title
Lens Dryness - Filcon II 3 and Etafilcon A
Description
Participant's subjective response for lens dryness of filcon II 3 and etafilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry 100=no dryness experienced).
Time Frame
3 hours and 6 hours
Title
Lens Dryness - Filcon II 3 and Nelfilcon A
Description
Participant's subjective response for lens dryness of filcon II 3 and nelfilcon A (surveyed at 3 and 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced).
Time Frame
3 hours and 6 hours
Title
Lens Handling - Filcon II 3 and Etafilcon A
Description
Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle causes pain, 100=very easy to handle).
Time Frame
Baseline visit
Title
Lens Handling - Filcon II 3 and Nelfilcon A
Description
Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following insertion (surveyed at baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Time Frame
Baseline visit
Title
Lens Handling (Removal) - Filcon II 3 and Etafilcon A
Description
Participant's subjective response for lens handling of filcon II 3 and etafilcon A following insertion (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Time Frame
6 hours
Title
Lens Handling (Removal) - Filcon II 3 and Nelfilcon A
Description
Participant's subjective response for lens handling of filcon II 3 and nelfilcon A following removal (surveyed 6 hours after baseline visit) rated by questionnaire (Scale 0-100, 0=very hard to handle, causes pain, 100=very easy to handle).
Time Frame
6 hours
Title
Lens Wettability - Filcon II 3 and Etafilcon A
Description
The ophthalmologist's objective assessment for lens wettability of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).
Time Frame
Baseline and 6 hours
Title
Lens Wettability - Filcon II 3 and Nelfilcon A
Description
The ophthalmologist's objective assessment for lens wettability of filcon II 3 and nelficon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Scale 0-4, 0.25 increments, 0=excellent wettability, 4=severely reduced wettability).
Time Frame
Baseline and 6 hours
Title
Lens Fit, Centration - Filcon II 3 and Etafilcon A
Description
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at baseline visit) by biomicroscopy (Optimum or Decentered N T S I).
N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior
Time Frame
Baseline
Title
Lens Fit, Centration - Filcon II 3 and Etafilcon A
Description
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and etafilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Time Frame
6 hours
Title
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
Description
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at baseline) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Time Frame
Baseline
Title
Lens Fit, Centration - Filcon II 3 and Nelfilcon A
Description
The ophthalmologist's objective assessment for lens fit for centration of filcon II 3 and nelfilcon A following insertion (assessed at 6 hours) by biomicroscopy (Optimum or Decentered N T S I) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior, T/I - Temporal/Interior
Time Frame
After 6 hours
Title
Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A
Description
The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).
Time Frame
Baseline and 6 hours
Title
Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A
Description
The ophthalmologist's objective assessment for lens fit for Post-Blink Movement of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (measured in Primary Gaze and recorded in 0.1mm steps).
Time Frame
Baseline and 6 hours
Title
Lens Fit, Tightness - Filcon II 3 and Etafilcon A
Description
The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and etafilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).
Time Frame
Baseline and 6 hours
Title
Lens Fit, Tightness - Filcon II 3 and Nelfilcon A
Description
The ophthalmologist's objective assessment for lens fit for tightness of filcon II 3 and nelfilcon A following insertion (assessed at baseline visit and 6 hours) by biomicroscopy (Percentage of tightness, 5 increments, 0-100, 0=extremely loose, 100=extremely tight).
Time Frame
Baseline and 6 hours
Title
Lens Surface Deposition - Filcon II 3 and Etafilcon A
Description
The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and etafilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).
Time Frame
6 hour
Title
Lens Surface Deposition - Filcon II 3 and Nelfilcon A
Description
The ophthalmologist's objective assessment for lens surface deposition of filcon II 3 and nelfilcon A following insertion (assessed at 6 hour visit) by biomicroscopy (Scale 0-4, 0.25 steps, 0=no deposits, 4=severe deposits).
Time Frame
6 hour
Title
High Contrast Visual Acuity - Filcon II 3 and Etafilcon A
Description
The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and etafilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value).
Time Frame
Baseline and 6 hours
Title
High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A
Description
The ophthalmologist's objective assessment of High Contrast Visual Acuity following filcon II 3 and nelfilcon A insertion (assessed at baseline visit and 6 hours) by computerized charts. (Positive logMAR values indicate poorer vision, negative values denote better vision than baseline 20/20 value)
Time Frame
Baseline and 6 hours
Title
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
Description
The ophthalmologist's objective assessment of corneal staining (extent) assessed at screening (before lens insertion) by biomicroscopy (Grade as a % of each zone).
N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Time Frame
6 hours
Title
Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
Description
The ophthalmologist's objective assessment of corneal staining (extent) assessed at 6 hours by biomicroscopy (Grade as a % of each zone).
N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Time Frame
6 hours
Title
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A
Description
The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).
Time Frame
Baseline and 6 hours
Title
Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A
Description
The ophthalmologist's objective assessment of conjunctival bulbar and limbal hyperemia assessed at screening (before lens insertion of filcon II 3 and nelfilcon A) by biomicroscopy (Scale 0-4, 0.5 increments, 0=no redness, 4=redness).
Time Frame
Baseline and 6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;
Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.
Demonstrates an acceptable fit with the study lenses
Exclusion Criteria:
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 (by verbal confirmation at the screening visit);
Is aphakic;
Has undergone refractive error surgery;
Facility Information:
Facility Name
Centre for Contact Lens Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Daily Disposable Comparison Study
We'll reach out to this number within 24 hrs