Central Corneal Swelling With Silicone Hydrogel Materials

June 18, 2018 updated by: Johnson & Johnson Vision Care, Inc.

Daily Wear Central Corneal Swelling With Etafilcon A and 2 Silicone Hydrogel Materials

This is a prospective, single site, unmasked, cross-over study with three silicone hydrogel contact lenses comparing central corneal swelling.

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.

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.
41

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

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The participant must be at leat 18 years old or older and no greater than 65 years old. Children younger than18 will likely no be able to come back and forth to the clinic during the typical work week as outlined in the above (due to school schedules) and thus not be able to adhere to the protocol.
  2. The participant must be a current soft contact lens wearer who routinely wears lenses at least 6-8 hours per day and at least 4 days per week for at least the past 3 months.
  3. Refraction suitable for spherical soft contact lens powers between -1.00 and -6.00 D the participant must be correctable to 20/30 or better at distance with both eyes with dispensed contact lenses.
  4. The participant must be free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis are not allowed. However, evidence of past CLPU will be allowed so long as no more than 3 such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the participant for subsequent CIE.
  5. The participant must be correctable to 20/25 or better in each eye with spectacles. Amblyopia will be excluded.
  6. Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively. Corneal curvatures outside this range may be indicative of a disease state, and the participants are not expected to comfortably wear the study lenses.
  7. The participant must own or agree to purchase a pair of spectacles that can be worn when lenses are removed, during the washout periods, or in case of ocular discomfort or emergency.

Exclusion Criteria:

  1. The participant has worn rigid gas permeable contact lenses within the last 30 days or PMMA lenses within the past 12 months. These lenses can transiently alter the corneal shape and influence the fitting of soft contact lenses or alter endothelial cell morphology.
  2. The participant has an immunocompromising disease or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during daily contact lens wear.
  3. The participant is taking any medication that in the investigator's opinion will affect ocular physiology or study participation.
  4. The participant has an ocular disease or condition such as aphakia, clinically significant corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
  5. The participant is taking any ocular medications. If a participant was previous taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment.
  6. The participant must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales.
  7. The participant is currently pregnant or lactating. Participant who become pregnant during the study will be discontinued.
  8. An employee or member of the UHCMC Eye Institute or a family member of any study personnel.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

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: etafilcon A/lotrafilcon B/comfilcon A
Subjects that were randomized to receive the etafilcon A lens 1st, the lotrafilcon B lens 2nd and the comfilcon A lens 3rd.
Device: etafilcon A
spherical hydrophilic soft contact lens worn in a daily wear modality
Other Names:
  • Investigational Soft Contact Lens -
Device: lotrafilcon B
Device: comfilcon A
Active Comparator: etafilcon A/comfilcon A/lotrafilcon B
Subjects that were randomized to receive the etafilcon A lens 1st, the comfilcon A lens 2nd and the lotrafilcon B lens 3rd.
Device: etafilcon A
spherical hydrophilic soft contact lens worn in a daily wear modality
Other Names:
  • Investigational Soft Contact Lens -
Device: lotrafilcon B
Device: comfilcon A
Active Comparator: comfilcon A/etafilcon A/lotrafilcon B
Subjects that were randomized to receive the comfilcon A lens 1st, the etafilcon A lens 2nd and the lotrafilcon B lens 3rd.
Device: etafilcon A
spherical hydrophilic soft contact lens worn in a daily wear modality
Other Names:
  • Investigational Soft Contact Lens -
Device: lotrafilcon B
Device: comfilcon A
Active Comparator: comfilcon A/lotrafilcon B/etafilcon A
Subjects that were randomized to receive the comfilcon A lens 1st, the lotrafilcon B lens 2nd and the etafilcon A lens 3rd.
Device: etafilcon A
spherical hydrophilic soft contact lens worn in a daily wear modality
Other Names:
  • Investigational Soft Contact Lens -
Device: lotrafilcon B
Device: comfilcon A
Active Comparator: lotrafilcon B/etafilcon A/comfilcon A
Subjects that were randomized to receive the lotrafilcon B lens 1st, the etafilcon A lens 2nd and the comfilcon A lens 3rd.
Device: etafilcon A
spherical hydrophilic soft contact lens worn in a daily wear modality
Other Names:
  • Investigational Soft Contact Lens -
Device: lotrafilcon B
Device: comfilcon A
Active Comparator: lotrafilcon B/comfilcon A/etafilcon A
Subjects that were randomized to receive the lotrafilcon B lens 1st, the comfilcon A lens 2nd and the etafilcon A lens 3rd.
Device: etafilcon A
spherical hydrophilic soft contact lens worn in a daily wear modality
Other Names:
  • Investigational Soft Contact Lens -
Device: lotrafilcon B
Device: comfilcon A

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
Central Corneal Swelling
Time Frame: 6-8 Hours Post lens insertion
Corneal swelling measurements were taken in the right eye during slit lamp evaluations, 6-8 hours post lens insertion. The average corneal swelling per lens was reported.
6-8 Hours Post lens insertion

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
Limbal Redness
Time Frame: 6-8 hours post lens insertion
Limbal redness was assessed in both eyes using a slit lamp, 6-8 hours post lens insertion. Redness was assessed in 4 regions of the eye (nasal, temporal, inferior and superior) and was graded with a 5-point scale (i.e. Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). For each region (nasal, temporal, inferior and superior) the average grade was calculated by lens. The Total Grade was then calculated by summing all the average grade for each region. The regional average grade ranges from 0 to 4. The total Grade ranges from 0 to 16.
6-8 hours post lens insertion

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.
Johnson & Johnson Vision Care, Inc.

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.
November 1, 2014

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, 2015

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 1, 2015

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).
December 3, 2014

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.
December 29, 2014

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.
December 31, 2014

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.
June 19, 2018

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.
June 18, 2018

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.
December 1, 2016

More Information

Terms related to this study

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.
  • CR-5550

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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