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Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

etafilcon A

omafilcon A

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 39 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

At least 18 years of age and no more than 39 years of age
Existing soft contact lens wearers
Willing to signed a written Informed Consent.
Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day.
Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes.
Have an Astigmatism of 1.00D or less in both eyes.
Require a visual correction in both eyes.
Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.
Have normal eyes with no evidence of abnormality or disease that would preclude lens wear.

Exclusion Criteria:

Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear.
Clinically significant corneal staining (Grade 3 in more than one region).
Keratoconus or other corneal irregularity.
Abnormal lachrymal secretions.
Extended wear of contact lenses last 3 months.
Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.
Refractive surgery.
Eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
Pre-existing ocular irritation that would preclude contact lens fitting.
Require concurrent ocular medication
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV).
Diabetes.
Pregnant, lactating or planning a pregnancy at the time of enrollment.
Participation in any concurrent clinical trial or in last 30 days.

Sites / Locations

Singapore Plytechnic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

etafilcon A/omafilcon A

omafilcon A/etafilcon A

Arm Description

etafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily

omafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily.

Outcomes

Primary Outcome Measures

Subjective Rating of Comfort

This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Vision Quality

This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Subjective Rating of Handling

This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Corneal Staining

Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.

Subjective Rating of Quality Perceptions

This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Limbal Hyperemia

This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.

Secondary Outcome Measures

Full Information

NCT ID

NCT01155323

First Posted

June 30, 2010

Last Updated

June 18, 2018

Sponsor

Johnson & Johnson Vision Care, Inc.

Collaborators

Johnson & Johnson K.K. Medical Company, Visioncare Research Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01155323

Brief Title

Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

Official Title

Proclear 1 Day Lens vs 1-Day Acuvue Moist Daily Disposable Contact Lens Crossover Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

March 1, 2010 (Actual)

Primary Completion Date

June 1, 2010 (Actual)

Study Completion Date

June 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johnson & Johnson Vision Care, Inc.

Collaborators

Johnson & Johnson K.K. Medical Company, Visioncare Research Ltd.

4. Oversight

5. Study Description

Brief Summary

This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

etafilcon A/omafilcon A

Arm Type

Active Comparator

Arm Description

etafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily

Arm Title

omafilcon A/etafilcon A

Arm Type

Active Comparator

Arm Description

omafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily.

Intervention Type

Device

Intervention Name(s)

etafilcon A

Intervention Description

1-day soft contact lens

Intervention Type

Device

Intervention Name(s)

omafilcon A

Intervention Description

1-day soft contact lens

Primary Outcome Measure Information:

Title

Subjective Rating of Comfort

Description

This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Time Frame

after 1 week of lens wear

Title

Vision Quality

Description

This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Time Frame

after 1 week of lens wear

Title

Subjective Rating of Handling

Description

This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Time Frame

after 1 week of lens wear

Title

Corneal Staining

Description

Time Frame

after 1 week of lens wear

Title

Subjective Rating of Quality Perceptions

Description

This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

Time Frame

after 1 week of lens wear

Title

Limbal Hyperemia

Description

This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.

Time Frame

after 1 week of wear

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: At least 18 years of age and no more than 39 years of age Existing soft contact lens wearers Willing to signed a written Informed Consent. Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day. Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes. Have an Astigmatism of 1.00D or less in both eyes. Require a visual correction in both eyes. Be correctable to a visual acuity of 6/9 (20/30) or better in each eye. Have normal eyes with no evidence of abnormality or disease that would preclude lens wear. Exclusion Criteria: Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear. Clinically significant corneal staining (Grade 3 in more than one region). Keratoconus or other corneal irregularity. Abnormal lachrymal secretions. Extended wear of contact lenses last 3 months. Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks. Refractive surgery. Eye injury/surgery within 8 weeks immediately prior to enrollment for this study. Pre-existing ocular irritation that would preclude contact lens fitting. Require concurrent ocular medication Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear. Any infectious disease (e.g., hepatitis, tuberculosis) or any immunosuppressive disease (e.g., HIV). Diabetes. Pregnant, lactating or planning a pregnancy at the time of enrollment. Participation in any concurrent clinical trial or in last 30 days.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Danny Sim, Diploma in Optometry

Organizational Affiliation

Singapore Polytechnic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Singapore Plytechnic

City

Singapore

ZIP/Postal Code

139651

Country

Singapore

12. IPD Sharing Statement

Learn more about this trial

Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

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