Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses

April 1, 2019 updated by: CooperVision, Inc.

Fitting Evaluation of Hydrogel and Silicone Hydrogel Sphere Design Contact Lenses.

The aim of this non-dispensing fitting study is to evaluate the short term lens fit, vision performance of three monthly replacement sphere lenses.

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

This is a 40-subject, double masked, randomized, bilateral, non-dispensing fitting trial comparing hydrogel and silicone hydrogel lens materials. It is anticipated that this study will involve 2 visits for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear each pair bilaterally in a series of three short fitting comparisons.

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.
40

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

  • Mexico
      • Mexico City, Mexico
        • Optometry Clinic, National Autonomous University

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 to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A person is eligible for inclusion in the study if he/she:

    • 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 (Contact Lens) wearer who is not wearing any of the study lenses.
    • Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
    • Has a spectacle cylinder up to 0.75D (Diopter) in each eye.
    • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
    • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
    • Has clear corneas and no active ocular disease.
    • Has read, understood and signed the information consent letter.
    • Patient contact lens refraction should fit within the available parameters of the study lenses.
    • Is willing to comply with the wear schedule.
    • Is willing to comply with the visit schedule.

Exclusion Criteria:

  • A person will be excluded from the study if he/she:

    • Has never worn contact lenses before.
    • Currently wears rigid gas permeable contact lenses.
    • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
    • Has a CL prescription outside the range of - 1.00 to - 6.00D
    • Has a spectacle cylinder ≥1.00D of cylinder in either eye.
    • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
    • Presence of clinically significant (grade 2-4) anterior segment abnormalities.
    • Presence of ocular or systemic disease or need of medications 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 of the limbus
      • Giant papillary conjunctivitis (GCP) worse than grade 1
      • Anterior uveitis or iritis (past or present)
      • Seborrheic eczema, Seborrheic conjunctivitis
      • History of corneal ulcers or fungal infections
      • Poor personal hygiene
    • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
    • Has aphakia, keratoconus or a highly irregular cornea.
    • Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
    • Has undergone corneal refractive surgery.
    • Is participating in any other type of eye related clinical or research study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

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.
Active Comparator: Omafilcon A
Participants are randomized to wear omafilcon A lens pair bilaterally for 1 hour during the study.
Device: Omafilcon A
contact lens
Active Comparator: Somofilcon A
Participants are randomized to wear somofilcon A lens pair bilaterally for 1 hour during the study.
Device: Somofilcon A
contact lens
Active Comparator: Omafilcon A - Proclear (PC)
Participants are randomized to wear omafilcon A - PC lens pair bilaterally for 1 hour during the study.
Device: Omafilcon A - Proclear (PC)
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
Visual Acuity
Time Frame: Baseline (lens insertion), 1 hour
High contrast distance visual acuity assessed for each lens pair using LogMAR chart at time of lens insertion, then assessing again 1 hour later with spectacles after lenses are removed.
Baseline (lens insertion), 1 hour
Comfort
Time Frame: Insertion, 1hr
Subjective comfort (Scale 0-100: 0=very uncomfortable, 100= very comfortable)
Insertion, 1hr
Lens Centration
Time Frame: Insertion
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
Insertion
Lens Centration
Time Frame: 1 Hour
Centration of lens on eye (Scale: Optimum, Decentration acceptable, Decentration unacceptable)
1 Hour
Post-blink Lens Movement
Time Frame: Insertion
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
Insertion
Post-blink Lens Movement
Time Frame: 1 Hour
Amount of lens movement after blink (Scale: Insufficient, Minimum, Optimum, Moderate, Excessive)
1 Hour
Lens Fit Acceptance
Time Frame: Insertion
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
Insertion
Lens Fit Acceptance
Time Frame: 1 Hour
Investigator's determination of whether lens fit is acceptable (Scale: Shouldn't be worn, Borderline, Min Acceptable, OK to dispense, Perfect)
1 Hour
Lens Fit Preference
Time Frame: 1 Hour
Investigator lens fit preference (Scale: omafilcon A, somofilcon A, omafilcon A - Proclear (PC))
1 Hour
Limbal Redness
Time Frame: 1 Hour
Redness of limbal area (Scale: 0-4, 0 = none, 4=severe)
1 Hour
Bulbar Redness
Time Frame: 1 Hour
Redness of bulbar conjunctiva (Scale: 0-4, 0 = none, 4=severe)
1 Hour

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: Ruben Velázquez Guerrero, MSc., FIACLE, National Autonomous University, School of Optometry

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 (Actual)

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.
February 1, 2017

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.
March 1, 2017

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.
April 11, 2017

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).
March 28, 2017

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 28, 2017

First Posted (Actual)

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.
April 4, 2017

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.
April 9, 2019

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.
April 1, 2019

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.
April 1, 2019

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-79

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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