Objective Testing of Tear Film Stability

Contact Lens Solutions Clinical Trial

Official title:

Objective Testing of Tear Film Stability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789529
• Other study ID #: CS-101
• Status: Completed
• Phase: N/A
• First received: November 11, 2008
• Last updated: April 22, 2013
• Start date: September 2008
• Est. completion date: November 2008

Study information

• Verified date: April 2013
• Source: Manhattan Vision Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The subject must be at least 18 years of age and no more than 80 years of age.

2. The subject must have a best corrected visual acuity of 20/30 or better for each eye.

3. The subject must habitually wear contact lenses.

4. The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit.

5. The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation.

6. The subject must read understand and sign the Statement of Informed Consent.

7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies or disease that might interfere with contact lens wear.

2. Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear.

3. Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear.

4. Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.

5. Any ocular infection.

6. Pregnancy or lactation.

7. Diabetes

8. Infectious diseases (e.g. hepatitis, tuberculosis)

9. Contagious immunosuppressive diseases (e.g. HIV)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Contact Lens Solutions

Intervention

Device:
• Opti-Free® RepleniSH® MPDS
soft contact lens disinfecting solution
• ReNu MultiPlus®
soft contact lens disinfecting solution

Locations

Country	Name	City	State
United States	MVA/IVR	New York City	New York

Sponsors (2)

Lead Sponsor	Collaborator
Manhattan Vision Associates	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective, In-vivo Soft Contact Lens Wettability Index	The wettability index is derived from the slope of a metric developed to measure the regularity of the Shack-Hartmann wavefront sensor image. The more wettable a lens is the more stable the metric and the slope of the metric (the wettability index) is closer to zero. The more negative values indicate a less wettable the lens.	2 weeks	No
Secondary	Subject Questionnaire Response	Subject questionnaire response: Overall comfort at 2 weeks in a 0-50 point scale.; 0=Very poor 50 = Excellent	2 weeks	No