Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution

Contact Lens Solutions Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636363
• Other study ID #: 554
• Status: Completed
• Phase: N/A
• First received: March 7, 2008
• Last updated: March 4, 2015
• Start date: March 2008
• Est. completion date: August 2008

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

To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution

Recruitment information / eligibility

• Status: Completed
• Enrollment: 541
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subject is a habitual wearer of a silicone hydrogel or group IV contact lens

• VA correctable to 0.3 LogMar or better (driving vision)

• Clear central cornea

• Subject uses a lens care system on a regular basis

Exclusion Criteria:

• Systemic disease affecting ocular health

• Using systemic or topical medications

• wear monovision, multifocal or toric contact lenses

• Any grade 2 or greater slit lamp findings

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Contact Lens Solutions

Intervention

Device:
• Bausch & Lomb Multipurpose Solution - Rub Care
Daily care for contact lenses - rub care regimen
• Bausch & Lomb Multipurpose Solution - No Rub Care
Daily care for contact lenses - no rub care regimen
• Ciba Vision Aquify Multipurpose Solution
daily care for contact lenses

Locations

Country	Name	City	State
United States	Place Eye Care	LeRoy	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	Slit-lamp Findings > Grade 2	eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.	Over 4 visits for 3 month period	No
Primary	Subjective Responses to Comfort Related Symptoms/Complaints	Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.	Over 4 visits for the 3 month period	No
Primary	Contact Lens Deposits	Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.	At each visit for 3 months	No