Clinical Evaluation of Daily Disposable Contact Lenses

Single-Center Clinical Evaluation of Daily Disposable Contact Lenses

The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: etafilcon A; Device: nelfilcon A; Device: filcon II 3

Detailed Description

Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720-2020
      • University of California, Berkeley Clinical Research Center (UCB-CRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Is between 18 and 40 years of age (inclusive)
• Has had a self-reported visual exam in the last two years
• Is an adapted soft CL wearer
• Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so
• Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
• Has less than 1.25 D spectacle cylinder in each eye.
• Baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
• Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter
• Is willing to comply with the wear schedule (at least 3 full days)
• Is willing to comply with the visit schedule

Exclusion Criteria:

• Has never worn contact lenses before.
• Currently wears rigid gas permeable contact lenses.
• Has a history of not achieving comfortable CL wear (3 days per week; > 8 hours/day)
• Has a CL prescription outside the range of - 1.00 to -6.00D
• Has a spectacle cylinder greater than -1.25D of cylinder in either eye.
• Has best corrected spectacle distance vision worse then 20/25 in either eye.
• Has any systemic disease affecting ocular health.
• Is using any systemic or topical medications, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. Occasional use is acceptable but not during the trial.
• Has any ocular pathology or severe insufficiency of lacrimal secretion
• Has persistent, clinically significant corneal or conjunctival staining
• Has active neovascularization or any central corneal scars.
• Is aphakic.
• Is presbyopic.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: etafilcon A lens; Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.	Device: etafilcon A; Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.; Other Names: Hydrogel Daily Disposable Contact Lens
Active Comparator: nelfilcon A lens; Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.	Device: nelfilcon A; Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.; Other Names: Hydrogel Daily Disposable Contact Lens
Active Comparator: filcon II 3 lens; Participants were randomized to either the etafilcon A or the nelfilcon A lens for three days and then both groups wore the filcon II 3 lens for three days, without washout period between lens types.	Device: filcon II 3; Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.; Other Names: Silicone Hydrogel Daily Disposable Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Lens Preference - All Study Lenses	Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).	Study Exit
Overall Lens Preference - Hydrogel vs. Filcon II 3	Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).	Study Exit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Response for Comfort	Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)	Baseline and 3 day follow-up
Subjective Response for Vision	Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).	Baseline and 3 day follow-up
Subjective Response for Insertion	Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).	Baseline
Subjective Response for Handling (Insertion and Removal)	Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).	3 days follow-up
Subjective Response for Dryness	Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).	3 Days Follow-up
Overall Satisfaction, Vision	Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.	3 Days Follow-up
Overall Satisfaction, Comfort	Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.	3 Days Follow-up
Overall Satisfaction, Handling	Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.	3 Days
Overall Satisfaction, Dryness	Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.	3 Days Follow-up
Overall Satisfaction	Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.	3 Days Follow-up
Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)	The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).	Baseline and 3 days follow-up
Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)	The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);	Baseline and 3 days follow-up
Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)	The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)	Baseline and 3 day follow-up
Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)	The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).	Baseline and 3 days follow-up
Lens Fit and Performance - Fit Acceptance	The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).	Baseline and 3 day follow-up
Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)	The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).	Baseline and 3 day follow-up
Ocular Health - Biomicroscopy	The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)	3 Days Follow-up

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Meng C Lin, OD, PhD, University of California, Berkeley

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 24, 2014
• First Posted (Estimate): March 26, 2014

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: EX-MKTG-46