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

NCT01155323 | Completed Results

• 2 other identifiers: CR-0926DISP-523
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

etafilcon A/omafilcon A

ACTIVE COMPARATOR

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; Device: omafilcon A

omafilcon A/etafilcon A

ACTIVE COMPARATOR

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; Device: omafilcon A

Interventions

etafilcon A DEVICE

1-day soft contact lens

etafilcon A/omafilcon A; omafilcon A/etafilcon A

omafilcon A DEVICE

1-day soft contact lens

etafilcon A/omafilcon A; omafilcon A/etafilcon A

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Johnson & Johnson K.K. Medical Company: collaborator
• Visioncare Research Ltd.: collaborator

Study Sites (1)

Singapore Plytechnic

Singapore, 139651, Singapore

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Wakana Katabami
• Organization: Johnson and Johnson K.K.

wkatabam@its.jnj.com

81-34411-8040

Study Officials

• Danny Sim, Diploma in Optometry

  Singapore Polytechnic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 1, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 19, 2018
• Results First Posted: October 4, 2011

Record last verified: 2017-08

Locations

SG (1)