Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

Vision Disorders Clinical Trial

Official title:

Performance Evaluation of Contact Lenses Among a Population of Adapted Contact Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985231
• Other study ID #: 630
• Status: Completed
• Phase: N/A
• First received: September 25, 2009
• Last updated: March 4, 2015
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: March 2015
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to evaluate Bausch & Lomb PureVision Multi-Focal contact lenses compared to the Bausch & Lomb SofLens59 contact lens when worn by adapted soft contact lens wearers on a daily wear basis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 40 Years

Eligibility

Inclusion Criteria:

• Subjects must have clear central corneas and be free of any anterior segment disorders.

• Subjects must be adapted soft contact lens wearers and agree to wear the study lenses on a daily wear basis for at least eight hours a day for approximately two weeks.

• Subjects must wear a lens in each eye and each lens must be of the same manufacture and brand.

Exclusion Criteria:

• Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

• Subjects with any systemic disease affecting ocular health

• Subjects with an active ocular disease or using any ocular medication.

• Subjects who have had any corneal surgery (eg, refractive surgery).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vision Disorders

Intervention

Device:
• PureVision Multi-Focal contact lenses
Contact lenses to be worn on a daily wear basis for 2 weeks.
• SofLens59 contact lens
Contact lenses to be worn on a daily wear basis for 2 weeks.

Locations

Country	Name	City	State
United States	Bausch & Lomb	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance Visual Acuity (VA) Between Test and Control Lenses Worse Than 20/40.	Eyes with distance lens VA of 20/40 or worse at study exit between test and control lenses.	2 weeks	No
Secondary	Subjective Ratings of Eye Strain	Convergence Insufficiency Symptom Survey (CISS), was used to assess eye strain symptoms measured on a scale of 1-4. 0 score=never, 4 score=always	2 week visit	No