Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

Myopia Clinical Trial

Official title:

Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813982
• Other study ID #: P-335-C-009
• Status: Completed
• Phase: N/A
• Start date: November 2008
• Est. completion date: December 2008

Study information

• Verified date: May 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day

• On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses

• Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

• Requires concurrent ocular medication

• Eye injury or surgery within twelve weeks immediately prior to enrollment

• Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions

• Any active corneal infection

• Any use of medications for which contact lens wear would be contraindicated

• History of corneal refractive surgery

• Wears toric contact lenses

• Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lotrafilcon A Experimental Contact Lens
Experimental spherical, silicone hydrogel soft contact lens
• Lotrafilcon A Commercial Contact Lens
Commercially marketed spherical, silicone hydrogel soft contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Vision	Overall vision was interpreted by the subject and recorded on a questionnaire as a single, retrospective evaluation of 1-week wear time. Overall vision was evaluated by eye and rated on a 10-point scale, with 1 being poor and 10 being excellent.	1 week