Clinical Performance Comparison of Two Contact Lenses

Myopia Clinical Trial

Official title:

Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975585
• Other study ID #: CR-0907
• Secondary ID: PHNX-518
• Status: Completed
• Phase: N/A
• Start date: August 1, 2009
• Est. completion date: October 1, 2009

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

The purpose of this study is to compare the clinical performance of two contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: October 1, 2009
• Est. primary completion date: October 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Existing daily soft lens wearer.

• Require a distance visual correction in both eyes.

• Have a contact lens spherical distance refraction between -1.00D and -6.00D.

• Have refractive astigmatism less than or equal to 1.00D in both eyes.

• Achieve 20/30 or better corrected distance acuity.

• Have normal eyes with no evidence of abnormality or disease.

Exclusion Criteria:

• Requires presbyopic correction.

• Requires ocular medications.

• Grade 3 or 4 ocular abnormalities.

• Grade 3 corneal staining in more than one region.

• Has had refractive surgery.

• Any other injury or ocular surgery within 8 weeks prior to study enrollment.

• Has abnormal lacrimal secretions.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Has keratoconus or other corneal irregularity.

• Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.

• Wears habitual contact lenses that are toric, multifocal or worn extended wear.

• Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.

• Diabetic.

• Infectious or immunosuppressive disease.

• History of chronic eye disease (e.g glaucoma or age related macular degeneration).

• Pregnancy, lactation or planning pregnancy at time of enrollment.

• Participation in any concurrent clinical trial or in another trial in the last 30 days.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• senofilcon A
soft contact lens, 2-week replacement indicated
• lotrafilcon B
soft contact lens with a 4-week replacement indicated.

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Corneal Staining	The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.	2 weeks
Primary	Visual Acuity	Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.	2 weeks
Primary	Overall Comfort	After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.	2 weeks
Primary	Overall Comfort	After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.	2 weeks and 4 weeks
Secondary	Limbal Redness	The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe	2 weeks
Secondary	Bulbar Redness	The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe	2 weeks
Secondary	Symptoms of Dryness	Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None	2 weeks