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Clinical Evaluation of Daily Disposable Contact Lenses

Single-Center Clinical Evaluation of Daily Disposable Contact Lenses

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02097030
Enrollment
35
Registered
2014-03-26
Start date
2014-03-31
Completion date
2014-04-30
Last updated
2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief summary

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.

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.

Interventions

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

DEVICEetafilcon A

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

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

Sponsors

CooperVision, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Overall Lens Preference - All Study LensesStudy ExitParticipant'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).
Overall Lens Preference - Hydrogel vs. Filcon II 3Study ExitParticipant'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).

Secondary

MeasureTime frameDescription
Subjective Response for VisionBaseline and 3 day follow-upParticipant'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).
Subjective Response for InsertionBaselineParticipant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Subjective Response for Handling (Insertion and Removal)3 days follow-upParticipant'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).
Subjective Response for Dryness3 Days Follow-upParticipant'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).
Overall Satisfaction, Vision3 Days Follow-upParticipant'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.
Overall Satisfaction, Handling3 DaysParticipant'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.
Overall Satisfaction, Dryness3 Days Follow-upParticipant'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.
Overall Satisfaction, Comfort3 Days Follow-upParticipant'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.
Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)Baseline and 3 days follow-upThe 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).
Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)Baseline and 3 days follow-upThe 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);
Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)Baseline and 3 day follow-upThe 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)
Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)Baseline and 3 days follow-upThe 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).
Lens Fit and Performance - Fit AcceptanceBaseline and 3 day follow-upThe 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).
Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)Baseline and 3 day follow-upThe 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).
Ocular Health - Biomicroscopy3 Days Follow-upThe 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)
Overall Satisfaction3 Days Follow-upParticipant'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.
Subjective Response for ComfortBaseline and 3 day follow-upParticipant'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)

Countries

United States

Participant flow

Recruitment details

Single center evaluation. Thirty five subjects were recruited and 30 subjects completed the trial.

Pre-assignment details

Three participants were enrolled in the study but did not meet inclusion criteria, therefore discontinued before lens randomization.

Participants by arm

ArmCount
Etafilcon A, Then 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. etafilcon A: contact lens filcon II 3: contact lens
14
Nelfilcon A, Then 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. nelfilcon A: contact lens filcon II 3: contact lens
16
Total30

Withdrawals & dropouts

PeriodReasonFG000FG001
First Intervention (3 Days)Lost to Follow-up10
First Intervention (3 Days)Visual Acuity01

Baseline characteristics

CharacteristicEtafilcon A, Then Filcon II 3Nelfilcon A, Then Filcon II 3Total
Age, Continuous21.5 years
STANDARD_DEVIATION 4.9
21.2 years
STANDARD_DEVIATION 5
21.4 years
STANDARD_DEVIATION 5
Sex: Female, Male
Female
12 Participants14 Participants26 Participants
Sex: Female, Male
Male
2 Participants2 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
1 / 160 / 140 / 30
serious
Total, serious adverse events
0 / 160 / 140 / 30

Outcome results

Primary

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

Population: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

ArmMeasureGroupValue (NUMBER)
Nelfilcon AOverall Lens Preference - All Study LensesStrongly Prefer5 participants
Nelfilcon AOverall Lens Preference - All Study LensesSlightly Prefer4 participants
Etafilcon AOverall Lens Preference - All Study LensesStrongly Prefer3 participants
Etafilcon AOverall Lens Preference - All Study LensesSlightly Prefer3 participants
Filcon II 3Overall Lens Preference - All Study LensesStrongly Prefer8 participants
Filcon II 3Overall Lens Preference - All Study LensesSlightly Prefer7 participants
Primary

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

Population: 30 subjects

ArmMeasureGroupValue (NUMBER)
Nelfilcon AOverall Lens Preference - Hydrogel vs. Filcon II 3Strongly Prefer8 participants
Nelfilcon AOverall Lens Preference - Hydrogel vs. Filcon II 3Slightly Prefer7 participants
Etafilcon AOverall Lens Preference - Hydrogel vs. Filcon II 3Strongly Prefer8 participants
Etafilcon AOverall Lens Preference - Hydrogel vs. Filcon II 3Slightly Prefer7 participants
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Nelfilcon ALens Fit and Performance - Debris (Baseline and 3 Day Follow-up)Baseline0.0 units on a scaleStandard Deviation 0
Nelfilcon ALens Fit and Performance - Debris (Baseline and 3 Day Follow-up)3 days follow up0.0 units on a scaleStandard Deviation 0
Etafilcon ALens Fit and Performance - Debris (Baseline and 3 Day Follow-up)Baseline0.0 units on a scaleStandard Deviation 0
Etafilcon ALens Fit and Performance - Debris (Baseline and 3 Day Follow-up)3 days follow up0.0 units on a scaleStandard Deviation 0
Filcon II 3Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)Baseline0.0 units on a scaleStandard Deviation 0
Filcon II 3Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up)3 days follow up0.1 units on a scaleStandard Deviation 0.6
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Nelfilcon ALens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)Baseline0.0 units on a scaleStandard Deviation 0
Nelfilcon ALens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)3 days follow up0.0 units on a scaleStandard Deviation 0
Etafilcon ALens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)Baseline0.1 units on a scaleStandard Deviation 0.3
Etafilcon ALens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)3 days follow up0.0 units on a scaleStandard Deviation 0
Filcon II 3Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)Baseline0.0 units on a scaleStandard Deviation 0
Filcon II 3Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up)3 days follow up0.0 units on a scaleStandard Deviation 0
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Nelfilcon ALens Fit and Performance - Fit AcceptanceBaseline3.6 units on a scaleStandard Deviation 0.2
Nelfilcon ALens Fit and Performance - Fit Acceptance3 days follow up3.6 units on a scaleStandard Deviation 0.3
Etafilcon ALens Fit and Performance - Fit AcceptanceBaseline3.6 units on a scaleStandard Deviation 0.2
Etafilcon ALens Fit and Performance - Fit Acceptance3 days follow up3.6 units on a scaleStandard Deviation 0.2
Filcon II 3Lens Fit and Performance - Fit AcceptanceBaseline3.7 units on a scaleStandard Deviation 0.2
Filcon II 3Lens Fit and Performance - Fit Acceptance3 days follow up3.7 units on a scaleStandard Deviation 0.2
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Nelfilcon ALens Fit and Performance - Movement (Baseline and 3 Days Follow-up)Baseline0.3 units on a scaleStandard Deviation 0.2
Nelfilcon ALens Fit and Performance - Movement (Baseline and 3 Days Follow-up)3 days follow up0.2 units on a scaleStandard Deviation 0.2
Etafilcon ALens Fit and Performance - Movement (Baseline and 3 Days Follow-up)Baseline0.3 units on a scaleStandard Deviation 0.2
Etafilcon ALens Fit and Performance - Movement (Baseline and 3 Days Follow-up)3 days follow up0.3 units on a scaleStandard Deviation 0.2
Filcon II 3Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)Baseline0.3 units on a scaleStandard Deviation 0.1
Filcon II 3Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up)3 days follow up0.3 units on a scaleStandard Deviation 0.2
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Nelfilcon ALens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)Baseline54.0 units on a scaleStandard Deviation 12
Nelfilcon ALens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)3 days follow up58.0 units on a scaleStandard Deviation 12
Etafilcon ALens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)Baseline56.0 units on a scaleStandard Deviation 11
Etafilcon ALens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)3 days follow up55 units on a scaleStandard Deviation 12
Filcon II 3Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)Baseline53.0 units on a scaleStandard Deviation 12
Filcon II 3Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up)3 days follow up54 units on a scaleStandard Deviation 11
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
Nelfilcon ALens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)Baseline3.5 units on a scaleStandard Deviation 0.3
Nelfilcon ALens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)3 days follow up3.6 units on a scaleStandard Deviation 0.2
Etafilcon ALens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)Baseline3.3 units on a scaleStandard Deviation 0.5
Etafilcon ALens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)3 days follow up3.2 units on a scaleStandard Deviation 0.6
Filcon II 3Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)Baseline3.4 units on a scaleStandard Deviation 0.4
Filcon II 3Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up)3 days follow up3.5 units on a scaleStandard Deviation 0.4
Secondary

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

Population: Only right eye data shown. Left eye data virtually identical. One subject had non-contact lens related adverse event in the nelfilcon A group. Subject temporarily discontinued and went on to complete the study.

ArmMeasureGroupValue (MEAN)Dispersion
Nelfilcon AOcular Health - BiomicroscopyBulbar Hyperemia (Temporal)0.81 units on a scaleStandard Deviation 0.3
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Depth (Superior).025 units on a scaleStandard Deviation 0.5
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Type (Superior)0.34 units on a scaleStandard Deviation 0.7
Nelfilcon AOcular Health - BiomicroscopyLimbal Hyperemia (Superior)0.38 units on a scaleStandard Deviation 0.4
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Depth (Temporal)0.13 units on a scaleStandard Deviation 0.3
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Type (Inferior)0.50 units on a scaleStandard Deviation 1
Nelfilcon AOcular Health - BiomicroscopyConjunctival Indent (Nasal)0.00 units on a scaleStandard Deviation 0
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Depth (Nasal)0.06 units on a scaleStandard Deviation 0.3
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Extent (Central)0.00 units on a scaleStandard Deviation 0
Nelfilcon AOcular Health - BiomicroscopyBulbar Hyperemia (Superior)0.63 units on a scaleStandard Deviation 0.4
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Depth (Central)0.00 units on a scaleStandard Deviation 0
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Extent (Nasal)0.03 units on a scaleStandard Deviation 0.1
Nelfilcon AOcular Health - BiomicroscopyLimbal Hyperemia (Temporal)0.44 units on a scaleStandard Deviation 0.4
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Extent (Inferior)0.41 units on a scaleStandard Deviation 0.7
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Extent (Temporal)0.09 units on a scaleStandard Deviation 0.3
Nelfilcon AOcular Health - BiomicroscopyConjunctival Staining (Inferior)0.19 units on a scaleStandard Deviation 0.4
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Extent (Superior)0.22 units on a scaleStandard Deviation 0.4
Nelfilcon AOcular Health - BiomicroscopyBulbar Hyperemia (Inferior)0.72 units on a scaleStandard Deviation 0.4
Nelfilcon AOcular Health - BiomicroscopyConjunctival Indent (Superior)0.06 units on a scaleStandard Deviation 0.3
Nelfilcon AOcular Health - BiomicroscopyConjunctival Staining (Superior)0.13 units on a scaleStandard Deviation 0.3
Nelfilcon AOcular Health - BiomicroscopyLimbal Hyperemia (Nasal)0.53 units on a scaleStandard Deviation 0.5
Nelfilcon AOcular Health - BiomicroscopyLimbal Hyperemia (Inferior)0.41 units on a scaleStandard Deviation 0.5
Nelfilcon AOcular Health - BiomicroscopyBulbar Hyperemia (Nasal)0.88 units on a scaleStandard Deviation 0.2
Nelfilcon AOcular Health - BiomicroscopyConjunctival Staining (Temporal)0.28 units on a scaleStandard Deviation 0.5
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Type (Central)0.00 units on a scaleStandard Deviation 0
Nelfilcon AOcular Health - BiomicroscopyConjunctival Indent (Inferior)0.06 units on a scaleStandard Deviation 0.3
Nelfilcon AOcular Health - BiomicroscopyConjunctival Staining (Nasal)0.34 units on a scaleStandard Deviation 0.6
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Type (Nasal)0.19 units on a scaleStandard Deviation 0.8
Nelfilcon AOcular Health - BiomicroscopyConjunctival Indent (Temporal)0.00 units on a scaleStandard Deviation 0
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Depth (Inferior)0.25 units on a scaleStandard Deviation 0.5
Nelfilcon AOcular Health - BiomicroscopyCorneal Staining Type (Temporal)0.16 units on a scaleStandard Deviation 0.4
Etafilcon AOcular Health - BiomicroscopyConjunctival Staining (Nasal)1.29 units on a scaleStandard Deviation 1.2
Etafilcon AOcular Health - BiomicroscopyLimbal Hyperemia (Temporal)0.89 units on a scaleStandard Deviation 0.7
Etafilcon AOcular Health - BiomicroscopyLimbal Hyperemia (Superior)0.68 units on a scaleStandard Deviation 0.7
Etafilcon AOcular Health - BiomicroscopyBulbar Hyperemia (Nasal)0.96 units on a scaleStandard Deviation 0.3
Etafilcon AOcular Health - BiomicroscopyBulbar Hyperemia (Temporal)0.96 units on a scaleStandard Deviation 0.2
Etafilcon AOcular Health - BiomicroscopyBulbar Hyperemia (Superior)0.64 units on a scaleStandard Deviation 0.5
Etafilcon AOcular Health - BiomicroscopyBulbar Hyperemia (Inferior)0.64 units on a scaleStandard Deviation 0.5
Etafilcon AOcular Health - BiomicroscopyLimbal Hyperemia (Nasal)0.96 units on a scaleStandard Deviation 0.7
Etafilcon AOcular Health - BiomicroscopyLimbal Hyperemia (Inferior)0.75 units on a scaleStandard Deviation 0.8
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Type (Central)0.18 units on a scaleStandard Deviation 0.5
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Type (Nasal)0.14 units on a scaleStandard Deviation 0.5
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Type (Temporal)0.25 units on a scaleStandard Deviation 0.7
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Type (Superior)0.07 units on a scaleStandard Deviation 0.3
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Type (Inferior)0.50 units on a scaleStandard Deviation 0.9
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Extent (Central)0.07 units on a scaleStandard Deviation 0.2
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Extent (Nasal)0.04 units on a scaleStandard Deviation 0.1
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Extent (Temporal)0.11 units on a scaleStandard Deviation 0.3
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Extent (Superior)0.04 units on a scaleStandard Deviation 0.1
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Extent (Inferior)0.32 units on a scaleStandard Deviation 0.6
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Depth (Central)0.14 units on a scaleStandard Deviation 0.4
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Depth (Nasal)0.07 units on a scaleStandard Deviation 0.3
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Depth (Temporal)0.14 units on a scaleStandard Deviation 0.4
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Depth (Superior)0.07 units on a scaleStandard Deviation 0.3
Etafilcon AOcular Health - BiomicroscopyCorneal Staining Depth (Inferior)0.29 units on a scaleStandard Deviation 0.5
Etafilcon AOcular Health - BiomicroscopyConjunctival Staining (Temporal)0.68 units on a scaleStandard Deviation 0.9
Etafilcon AOcular Health - BiomicroscopyConjunctival Staining (Superior)0.04 units on a scaleStandard Deviation 0.1
Etafilcon AOcular Health - BiomicroscopyConjunctival Staining (Inferior)0.64 units on a scaleStandard Deviation 0.9
Etafilcon AOcular Health - BiomicroscopyConjunctival Indent (Nasal)0.00 units on a scaleStandard Deviation 0
Etafilcon AOcular Health - BiomicroscopyConjunctival Indent (Temporal)0.00 units on a scaleStandard Deviation 0
Etafilcon AOcular Health - BiomicroscopyConjunctival Indent (Superior)0.00 units on a scaleStandard Deviation 0
Etafilcon AOcular Health - BiomicroscopyConjunctival Indent (Inferior)0.00 units on a scaleStandard Deviation 0
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Depth (Temporal)0.17 units on a scaleStandard Deviation 0.4
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Type (Temporal)0.32 units on a scaleStandard Deviation 0.8
Filcon II 3Ocular Health - BiomicroscopyBulbar Hyperemia (Nasal)0.95 units on a scaleStandard Deviation 0.4
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Depth (Superior)0.20 units on a scaleStandard Deviation 0.4
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Type (Nasal)0.07 units on a scaleStandard Deviation 0.4
Filcon II 3Ocular Health - BiomicroscopyLimbal Hyperemia (Temporal)0.38 units on a scaleStandard Deviation 0.5
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Depth (Inferior)0.40 units on a scaleStandard Deviation 0.5
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Type (Central)0.17 units on a scaleStandard Deviation 0.6
Filcon II 3Ocular Health - BiomicroscopyLimbal Hyperemia (Nasal)0.47 units on a scaleStandard Deviation 0.6
Filcon II 3Ocular Health - BiomicroscopyConjunctival Staining (Nasal)1.65 units on a scaleStandard Deviation 0.9
Filcon II 3Ocular Health - BiomicroscopyLimbal Hyperemia (Inferior)0.33 units on a scaleStandard Deviation 0.5
Filcon II 3Ocular Health - BiomicroscopyConjunctival Indent (Temporal)0.28 units on a scaleStandard Deviation 0.5
Filcon II 3Ocular Health - BiomicroscopyConjunctival Staining (Temporal)1.65 units on a scaleStandard Deviation 0.9
Filcon II 3Ocular Health - BiomicroscopyBulbar Hyperemia (Inferior)0.75 units on a scaleStandard Deviation 0.5
Filcon II 3Ocular Health - BiomicroscopyLimbal Hyperemia (Superior)0.30 units on a scaleStandard Deviation 0.4
Filcon II 3Ocular Health - BiomicroscopyConjunctival Staining (Superior)1.48 units on a scaleStandard Deviation 0.8
Filcon II 3Ocular Health - BiomicroscopyBulbar Hyperemia (Superior)0.72 units on a scaleStandard Deviation 0.5
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Extent (Temporal)0.10 units on a scaleStandard Deviation 0.2
Filcon II 3Ocular Health - BiomicroscopyConjunctival Indent (Inferior)0.20 units on a scaleStandard Deviation 0.5
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Extent (Superior)0.22 units on a scaleStandard Deviation 0.5
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Extent (Nasal)0.02 units on a scaleStandard Deviation 0.1
Filcon II 3Ocular Health - BiomicroscopyConjunctival Staining (Inferior)1.55 units on a scaleStandard Deviation 0.8
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Extent (Inferior)0.38 units on a scaleStandard Deviation 0.6
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Extent (Central)0.08 units on a scaleStandard Deviation 0.3
Filcon II 3Ocular Health - BiomicroscopyBulbar Hyperemia (Temporal)0.98 units on a scaleStandard Deviation 0.4
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Depth (Central)0.10 units on a scaleStandard Deviation 0.3
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Type (Inferior)0.67 units on a scaleStandard Deviation 0.9
Filcon II 3Ocular Health - BiomicroscopyConjunctival Indent (Superior)0.22 units on a scaleStandard Deviation 0.5
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Depth (Nasal)0.03 units on a scaleStandard Deviation 0.2
Filcon II 3Ocular Health - BiomicroscopyCorneal Staining Type (Superior)0.38 units on a scaleStandard Deviation 0.8
Filcon II 3Ocular Health - BiomicroscopyConjunctival Indent (Nasal)0.28 units on a scaleStandard Deviation 0.5
Secondary

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

Population: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

ArmMeasureGroupValue (NUMBER)
Nelfilcon AOverall SatisfactionSomewhat Satisfied8 participants
Nelfilcon AOverall SatisfactionCompletely Satisfied7 participants
Nelfilcon AOverall SatisfactionSomewhat Dissatisfied1 participants
Nelfilcon AOverall SatisfactionCompletely Dissatisfied0 participants
Etafilcon AOverall SatisfactionCompletely Dissatisfied0 participants
Etafilcon AOverall SatisfactionSomewhat Dissatisfied1 participants
Etafilcon AOverall SatisfactionCompletely Satisfied4 participants
Etafilcon AOverall SatisfactionSomewhat Satisfied9 participants
Filcon II 3Overall SatisfactionCompletely Satisfied15 participants
Filcon II 3Overall SatisfactionCompletely Dissatisfied1 participants
Filcon II 3Overall SatisfactionSomewhat Dissatisfied3 participants
Filcon II 3Overall SatisfactionSomewhat Satisfied11 participants
Secondary

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

Population: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

ArmMeasureGroupValue (NUMBER)
Nelfilcon AOverall Satisfaction, ComfortCompletely Dissatisfied0 participants
Nelfilcon AOverall Satisfaction, ComfortSomewhat Dissatisfied3 participants
Nelfilcon AOverall Satisfaction, ComfortSomewhat Satisfied5 participants
Nelfilcon AOverall Satisfaction, ComfortCompletely Satisfied8 participants
Etafilcon AOverall Satisfaction, ComfortCompletely Satisfied5 participants
Etafilcon AOverall Satisfaction, ComfortCompletely Dissatisfied0 participants
Etafilcon AOverall Satisfaction, ComfortSomewhat Satisfied8 participants
Etafilcon AOverall Satisfaction, ComfortSomewhat Dissatisfied1 participants
Filcon II 3Overall Satisfaction, ComfortCompletely Satisfied16 participants
Filcon II 3Overall Satisfaction, ComfortSomewhat Dissatisfied5 participants
Filcon II 3Overall Satisfaction, ComfortSomewhat Satisfied9 participants
Filcon II 3Overall Satisfaction, ComfortCompletely Dissatisfied0 participants
Secondary

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

Population: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

ArmMeasureGroupValue (NUMBER)
Nelfilcon AOverall Satisfaction, DrynessCompletely Dissatisfied1 participants
Nelfilcon AOverall Satisfaction, DrynessSomewhat Dissatisfied4 participants
Nelfilcon AOverall Satisfaction, DrynessSomewhat Satisfied6 participants
Nelfilcon AOverall Satisfaction, DrynessCompletely Satisfied5 participants
Etafilcon AOverall Satisfaction, DrynessCompletely Satisfied6 participants
Etafilcon AOverall Satisfaction, DrynessCompletely Dissatisfied0 participants
Etafilcon AOverall Satisfaction, DrynessSomewhat Satisfied5 participants
Etafilcon AOverall Satisfaction, DrynessSomewhat Dissatisfied3 participants
Filcon II 3Overall Satisfaction, DrynessCompletely Satisfied11 participants
Filcon II 3Overall Satisfaction, DrynessSomewhat Dissatisfied5 participants
Filcon II 3Overall Satisfaction, DrynessSomewhat Satisfied12 participants
Filcon II 3Overall Satisfaction, DrynessCompletely Dissatisfied2 participants
Secondary

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

Population: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

ArmMeasureGroupValue (NUMBER)
Nelfilcon AOverall Satisfaction, HandlingCompletely Dissatisfied0 participants
Nelfilcon AOverall Satisfaction, HandlingSomewhat Dissatisfied1 participants
Nelfilcon AOverall Satisfaction, HandlingSomewhat Satisfied6 participants
Nelfilcon AOverall Satisfaction, HandlingCompletely Satisfied9 participants
Etafilcon AOverall Satisfaction, HandlingCompletely Satisfied7 participants
Etafilcon AOverall Satisfaction, HandlingCompletely Dissatisfied0 participants
Etafilcon AOverall Satisfaction, HandlingSomewhat Satisfied3 participants
Etafilcon AOverall Satisfaction, HandlingSomewhat Dissatisfied4 participants
Filcon II 3Overall Satisfaction, HandlingCompletely Satisfied16 participants
Filcon II 3Overall Satisfaction, HandlingSomewhat Dissatisfied4 participants
Filcon II 3Overall Satisfaction, HandlingSomewhat Satisfied10 participants
Filcon II 3Overall Satisfaction, HandlingCompletely Dissatisfied0 participants
Secondary

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

Population: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

ArmMeasureGroupValue (NUMBER)
Nelfilcon AOverall Satisfaction, VisionCompletely Dissatisfied0 participants
Nelfilcon AOverall Satisfaction, VisionSomewhat Dissatisfied0 participants
Nelfilcon AOverall Satisfaction, VisionSomewhat Satisfied2 participants
Nelfilcon AOverall Satisfaction, VisionCompletely Satisfied14 participants
Etafilcon AOverall Satisfaction, VisionCompletely Satisfied11 participants
Etafilcon AOverall Satisfaction, VisionCompletely Dissatisfied0 participants
Etafilcon AOverall Satisfaction, VisionSomewhat Satisfied2 participants
Etafilcon AOverall Satisfaction, VisionSomewhat Dissatisfied1 participants
Filcon II 3Overall Satisfaction, VisionCompletely Satisfied24 participants
Filcon II 3Overall Satisfaction, VisionSomewhat Dissatisfied0 participants
Filcon II 3Overall Satisfaction, VisionSomewhat Satisfied6 participants
Filcon II 3Overall Satisfaction, VisionCompletely Dissatisfied0 participants
Secondary

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

Population: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

ArmMeasureGroupValue (MEAN)Dispersion
Nelfilcon ASubjective Response for ComfortBaseline90.3 units on a scaleStandard Deviation 15.9
Nelfilcon ASubjective Response for Comfort3 day follow up84.5 units on a scaleStandard Deviation 12.2
Etafilcon ASubjective Response for ComfortBaseline94.1 units on a scaleStandard Deviation 8.7
Etafilcon ASubjective Response for Comfort3 day follow up82.0 units on a scaleStandard Deviation 16.3
Filcon II 3Subjective Response for ComfortBaseline93.2 units on a scaleStandard Deviation 9.5
Filcon II 3Subjective Response for Comfort3 day follow up81.5 units on a scaleStandard Deviation 20.1
Secondary

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

Population: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

ArmMeasureValue (MEAN)Dispersion
Nelfilcon ASubjective Response for Dryness80.6 units on a scaleStandard Deviation 16.8
Etafilcon ASubjective Response for Dryness81.6 units on a scaleStandard Deviation 19
Filcon II 3Subjective Response for Dryness76.4 units on a scaleStandard Deviation 21.5
Secondary

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).

Time frame: 3 days follow-up

Population: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

ArmMeasureGroupValue (MEAN)Dispersion
Nelfilcon ASubjective Response for Handling (Insertion and Removal)Insertion92.9 units on a scaleStandard Deviation 11.6
Nelfilcon ASubjective Response for Handling (Insertion and Removal)Removal88.6 units on a scaleStandard Deviation 14.8
Etafilcon ASubjective Response for Handling (Insertion and Removal)Insertion74.1 units on a scaleStandard Deviation 23.6
Etafilcon ASubjective Response for Handling (Insertion and Removal)Removal94.8 units on a scaleStandard Deviation 8
Filcon II 3Subjective Response for Handling (Insertion and Removal)Insertion91.3 units on a scaleStandard Deviation 10.1
Filcon II 3Subjective Response for Handling (Insertion and Removal)Removal93.9 units on a scaleStandard Deviation 11.8
Secondary

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

Population: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

ArmMeasureValue (MEAN)Dispersion
Nelfilcon ASubjective Response for Insertion94.6 units on a scaleStandard Deviation 8.5
Etafilcon ASubjective Response for Insertion86.4 units on a scaleStandard Deviation 18.4
Filcon II 3Subjective Response for Insertion91.0 units on a scaleStandard Deviation 15.1
Secondary

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

Population: Subjects were randomized to wear one or the other of the conventional hydrogel lenses; all subjects wore the Clariti silicone hydrogel lenses.

ArmMeasureGroupValue (MEAN)Dispersion
Nelfilcon ASubjective Response for VisionBaseline93.8 units on a scaleStandard Deviation 8.2
Nelfilcon ASubjective Response for Vision3 day follow up94.8 units on a scaleStandard Deviation 5.4
Etafilcon ASubjective Response for VisionBaseline93.0 units on a scaleStandard Deviation 9.6
Etafilcon ASubjective Response for Vision3 day follow up90.6 units on a scaleStandard Deviation 15.8
Filcon II 3Subjective Response for VisionBaseline94.1 units on a scaleStandard Deviation 6.1
Filcon II 3Subjective Response for Vision3 day follow up95.2 units on a scaleStandard Deviation 5.1

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026