Daily Disposable Comparison Study

Myopia Clinical Trial

Official title:

Daily Disposable Comparison Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094677
• Other study ID #: EX-MKTG-50
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: April 2014

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

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

4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;

5. Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.

6. Demonstrates an acceptable fit with the study lenses

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);

7. Is aphakic;

8. Has undergone refractive error surgery;

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• filcon II 3
Participants were randomized to wear filcon II 3 test lens.
• etafilcon A
Participants were randomized to wear etafilcon A control lens.
• nelfilcon A
Participants were randomized to wear nelfilcon A control lens.

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline visit
Primary	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).	3 hours
Primary	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).	6 hours
Secondary	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).	Baseline, 3 hours, 6 hours
Secondary	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).	Baseline, 3 hours, 6 hours
Secondary	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).	3 hours and 6 hours
Secondary	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).	3 hours and 6 hours
Secondary	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).	Baseline visit
Secondary	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).	Baseline visit
Secondary	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).	6 hours
Secondary	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).	6 hours
Secondary	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).	Baseline and 6 hours
Secondary	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).	Baseline and 6 hours
Secondary	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	Baseline
Secondary	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	6 hours
Secondary	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	Baseline
Secondary	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	After 6 hours
Secondary	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).	Baseline and 6 hours
Secondary	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).	Baseline and 6 hours
Secondary	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).	Baseline and 6 hours
Secondary	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).	Baseline and 6 hours
Secondary	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).	6 hour
Secondary	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).	6 hour
Secondary	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).	Baseline and 6 hours
Secondary	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)	Baseline and 6 hours
Secondary	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	6 hours
Secondary	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	6 hours
Secondary	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).	Baseline and 6 hours
Secondary	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).	Baseline and 6 hours