Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A

Myopia Clinical Trial

Official title:

Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240135
• Other study ID #: C-10-030
• Status: Completed
• Phase: N/A
• First received: November 10, 2010
• Last updated: June 8, 2012
• Start date: October 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2012
• Source: Alcon Research
• 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 clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older.

• History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.

• Wear contact lenses a minimum of 8 hours per day prior to Visit 1.

• Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.

• Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.

• History of intolerance or known sensitivity to any component of the treatments.

• Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Contact Lens Fit
• Myopia

Intervention

Device:
• FID 114675A multi-purpose disinfecting solution (MPDS)
Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
• renu fresh Multi-Purpose Solution (MPS)
Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
• Galyfilcon A contact lenses (Acuvue Advance)
A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lens Fit	As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.	Day 14 of lens wear	No
Secondary	Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score	The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.	Day 14 of lens wear	No