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

NCT00636363 | Completed Results

• 1 other identifier: 554
• Study Type: interventional
• Target: 541
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contact Lens Solutions

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Multipurpose Solution - Rub Care

EXPERIMENTAL

Bausch \& Lomb Multipurpose Solution for use with contact lens care

Device: Bausch & Lomb Multipurpose Solution - Rub Care

Multipurpose Solution - No Rub Care

EXPERIMENTAL

Bausch \& Lomb Multipurpose Solution for use with contact lens care

Device: Bausch & Lomb Multipurpose Solution - No Rub Care

Ciba Vision Aquify Multipurpose Solution

ACTIVE COMPARATOR

Ciba Vision Aquify Multipurpose Solution for use with contact lens care

Device: Ciba Vision Aquify Multipurpose Solution

Interventions

Bausch & Lomb Multipurpose Solution - Rub Care DEVICE

Daily care for contact lenses - rub care regimen

Multipurpose Solution - Rub Care

Bausch & Lomb Multipurpose Solution - No Rub Care DEVICE

Daily care for contact lenses - no rub care regimen

Multipurpose Solution - No Rub Care

Ciba Vision Aquify Multipurpose Solution DEVICE

daily care for contact lenses

Ciba Vision Aquify Multipurpose Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Place Eye Care

Le Roy, New York, 14482, United States

Location

Results Point of Contact

• Title: Robert Steffen
• Organization: Bausch & Lomb

robert.steffen@bausch.com

(585) 338-6399

Study Officials

• Mohinder Merchea, OD, PhD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 14, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 24, 2015
• Results First Posted: April 8, 2011

Record last verified: 2015-03

Locations

US (1)