Clinical Performance of Stenfilcon A Versus Filcon II 3

July 19, 2020 updated by: CooperVision, Inc.
Clinical Performance of Stenfilcon vs. Filcon II 3

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no difference in the clinical performance between the two sets of lenses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B4 7ET
        • University of Aston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

  • Based on his/her knowledge, must be in good general health. Be of legal age (18 years) or older.
  • Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
  • Read, indicate understanding of, and sign Written Informed Consent (Appendix 1)
  • Require a contact lens prescription between -0.50 and -6.00 and have no more than -.75dioptor (D) of astigmatism in both eyes
  • Achieve visual acuity of 6/9 or better in each eye with a spherical contact lens prescription.
  • An existing soft contact lens wearer of any modality.
  • Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so.
  • Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
  • No amblyopia.
  • No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
  • No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings greater than Grade 2: corneal edema, tarsal abnormalities, and conjunctival injection).
  • No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.)
  • No aphakia

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

  • Neophytes, who have not worn lenses before
  • Greater than 0.75D of refractive astigmatism in either eye
  • Presence of clinically significant (grade 3 or above) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
  • Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
  • Slit lamp findings that would contraindicate contact lens wear such as:
  • Pathological dry eye or associated findings
  • Pterygium, pinguecula or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from the limbus
  • Giant papillary conjunctivitis (GPC) Grade 3 or above
  • Anterior uveitis or iritis (past or present)
  • Seborrheic eczema, seborrheic conjunctivitis
  • History of corneal ulcer or fungal infections
  • Poor personal hygiene
  • A known history of corneal hypoesthesia (reduced corneal sensitivity).
  • Contact lens best corrected Snellen visual acuities (VA) worse than 6/9
  • Aphakia, Keratoconus or a highly irregular cornea

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: stenfilcon A
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Device: filcon II 3
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Other Names:
  • filcon II 3 (Daily Disposable Contact Lens)
Active Comparator: filcon II 3
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Device: stenfilcon A
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Other Names:
  • stenfilcon A (Daily Disposable Contact Lens)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Daily and Comfortable Wearing Time
Time Frame: Baseline
Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)
Baseline
Daily and Comfortable Wearing Time
Time Frame: 1 week
Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)
1 week
Handling
Time Frame: 1 Week
Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).
1 Week
Comfort
Time Frame: Baseline
Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)
Baseline
Comfort
Time Frame: 1 Week
Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
1 Week
Dryness
Time Frame: Baseline
Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)
Baseline
Dryness
Time Frame: 1 Week
Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
1 Week
Vision Quality
Time Frame: Baseline
Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
Baseline
Vision Quality
Time Frame: 1 Week
Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
1 Week
Eye Whiteness
Time Frame: Baseline
Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
Baseline
Eye Whiteness
Time Frame: 1 Week
Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
1 Week
Overall Satisfaction
Time Frame: Baseline
Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Baseline
Overall Satisfaction
Time Frame: 1 Week
Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
1 Week
Visual Acuity logMAR
Time Frame: Baseline
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.
Baseline
Visual Acuity logMAR
Time Frame: Dispense
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.
Dispense
Visual Acuity logMAR
Time Frame: 1 Week
Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR
1 Week
Wettability
Time Frame: 1 Week
Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.
1 Week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood Vessel Coverage
Time Frame: Baseline
Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage.
Baseline
Blood Vessel Coverage
Time Frame: 1 Week
Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.
1 Week
Conjunctival Redness
Time Frame: Baseline
Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness.
Baseline
Conjunctival Redness
Time Frame: 1 Week
Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.
1 Week
Corneal Staining
Time Frame: Baseline
Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
Baseline
Corneal Staining
Time Frame: 1 Week
Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
1 Week
Conjunctival Staining
Time Frame: 1 Week
Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CooperVision, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Wolffsohn, PhD, University of Aston Birmingham, West Midlands, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EX-MKTG-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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