Clinical Evaluation of Daily Disposable Contact Lenses

N/ACompletedNCT02097030

CooperVision, Inc.35 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Myopia

Interventions

filcon II 3DEVICE

Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.

etafilcon ADEVICE

Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.

nelfilcon ADEVICE

Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of California, Berkeley Clinical Research Center (UCB-CRC)

Berkeley, California, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: Study Exit

Secondary Outcomes

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)

Time frame: 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).

Time frame: 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).

Time frame: 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).

Data from ClinicalTrials.gov

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Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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);

Time frame: 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)

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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)

Time frame: 3 Days Follow-up