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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155323
• Other study ID #: CR-0926
• Secondary ID: DISP-523
• Status: Completed
• Phase: N/A
• Start date: March 1, 2010
• Est. completion date: June 1, 2010

Study information

• Verified date: August 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 1, 2010
• Est. primary completion date: June 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• etafilcon A
1-day soft contact lens
• omafilcon A
1-day soft contact lens

Locations

Country	Name	City	State
Singapore	Singapore Plytechnic	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	Johnson & Johnson K.K. Medical Company, Visioncare Research Ltd.

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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