Daily Disposable Comparison Study

NCT02094677 | Completed Results

• 1 other identifier: EX-MKTG-50
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (26)

• Lens Comfort - Filcon II 3 and Etafilcon A

  Baseline, 3 hours, 6 hours

• Lens Comfort - Filcon II 3 and Nelficon A

  Baseline, 3 hours, 6 hours

• Lens Dryness - Filcon II 3 and Etafilcon A

  3 hours and 6 hours

• Lens Dryness - Filcon II 3 and Nelfilcon A

  3 hours and 6 hours

• Lens Handling - Filcon II 3 and Etafilcon A

  Baseline visit

Study Arms (2)

filcon II 3 and etafilcon A

ACTIVE COMPARATOR

Participants were randomized to a test and control lens for each group in a contralateral design.

Device: filcon II 3; Device: etafilcon A

filcon II 3 and nelfilcon A

ACTIVE COMPARATOR

Participants were randomized to a test and control lens for each group in a contralateral design.

Device: filcon II 3; Device: nelfilcon A

Interventions

filcon II 3 DEVICE

Participants were randomized to wear filcon II 3 test lens.

Also known as: Hydrogel Daily Disposable Contact Lens

filcon II 3 and etafilcon A; filcon II 3 and nelfilcon A

etafilcon A DEVICE

Participants were randomized to wear etafilcon A control lens.

Also known as: Hydrogel Daily Disposable Contact Lens, 1 Day Acuvue Moist

filcon II 3 and etafilcon A

nelfilcon A DEVICE

Participants were randomized to wear nelfilcon A control lens.

Also known as: Hydrogel Daily Disposable Contact Lens, Dailies Aqua Comfort Plus

filcon II 3 and nelfilcon A

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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 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

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 (by verbal confirmation at the screening visit);
• Is aphakic;
• Has undergone refractive error surgery;

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs
• Organization: Coopervision

jvega@coopervision.com

(925) 621-3761

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 24, 2014
• Study Start: March 1, 2014
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 28, 2020
• Results First Posted: March 11, 2016

Record last verified: 2020-07

Locations

CA (1)