Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

NCT00762385 | Completed Results

• 1 other identifier: CR-0713
• Study Type: interventional
• Target: 97
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (2)

• Lens Comfort

  \>0 = comfortable, \<0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.

  1-week, 2- weeks

• Comfort Symptoms

  A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. \>0 = comfortable, \<0 = uncomfortable

  1-week, 2-weeks

Secondary Outcomes (1)

• Overall Corneal Staining

  2 weeks

Study Arms (2)

galyfilcon A/comfilcon A

ACTIVE COMPARATOR

galyfilcon A first, comfilcon A second

Device: galyfilcon A; Device: comfilcon A

comfilcon A/galyfilcon A

ACTIVE COMPARATOR

comfilcon A first, galyfilcon A second

Device: galyfilcon A; Device: comfilcon A

Interventions

galyfilcon A DEVICE

galyfilcon A

comfilcon A/galyfilcon A; galyfilcon A/comfilcon A

comfilcon A DEVICE

comfilcon A

comfilcon A/galyfilcon A; galyfilcon A/comfilcon A

Eligibility Criteria

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

You may qualify if:

• The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
• The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
• The subject, based on his/her knowledge, must be in good general health.
• The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
• Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
• Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
• Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.
• The subject must read, indicate understanding of and sign the Informed Consent Form.

You may not qualify if:

• The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
• The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)
• Slit lamp findings that would contraindicate contact lens wear such as:
• pathological dry eye or associated findings
• pterygium or corneal scars within the visual axis
• neovascularization equal to or greater than 1mm in from the limbus
• history of giant papillary conjunctivitis (GPC) worse than grade 2
• anterior uveitis or iritis (past or present)
• seborrhoeic eczema
• seborrhoeic conjunctivitis
• A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
• A known history of corneal hypoesthesia (reduced corneal sensitivity).
• Contact lens snellen visual acuities (VA) worse than 20/30.
• Aphakia, keratoconus or a highly irregular cornea.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead
• Foresight Regulatory Strategies, Inc.: collaborator
• Visioncare Research Ltd.: collaborator

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Kurt Moody, OD FAAO
• Organization: Vistakon

904-443-3088

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: September 29, 2008
• First Posted: September 30, 2008
• Study Start: August 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: June 19, 2018
• Results First Posted: February 10, 2010

Record last verified: 2015-05