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

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: etafilcon A; Device: omafilcon A

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 139651
    • Singapore Plytechnic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: etafilcon A/omafilcon A; 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	Device: etafilcon A; 1-day soft contact lens; Device: omafilcon A; 1-day soft contact lens
Active Comparator: omafilcon A/etafilcon A; 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.	Device: etafilcon A; 1-day soft contact lens; Device: omafilcon A; 1-day soft contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	after 1 week of lens wear
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.	after 1 week of lens wear
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.	after 1 week of lens wear
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.	after 1 week of lens wear
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.	after 1 week of lens wear
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.	after 1 week of wear

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Visioncare Research Ltd.; Johnson & Johnson K.K. Medical Company
• Investigators: Principal Investigator: Danny Sim, Diploma in Optometry, Singapore Polytechnic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 30, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (Estimate): July 1, 2010

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CR-0926; DISP-523 (Other Identifier: Visioncare Research Ltd)