Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers

Myopia Clinical Trial

Official title:

Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912768
• Other study ID #: C-13-003
• Status: Completed
• Phase: N/A
• First received: July 29, 2013
• Last updated: June 10, 2015
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• 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 demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.

Description:

Subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Normal eyes (other than correction for visual acuity);

• Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;

• Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the investigational products or affect the results of this study;

• Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;

• Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;

• History of intolerance or hypersensitivity to any component of the investigational products;

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

• Moderate, severe, abnormal, or other ocular findings;

• Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;

• Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;

• Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;

• Ocular surgery within the last 12 months;

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Astigmatism
• Hyperopia
• Myopia
• Refractive Error
• Refractive Errors

Intervention

Device:
• FID 120947A contact lens disinfecting solution
Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses
• renu fresh multi-purpose solution
Commercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses
• Soft contact lenses
Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Visibly Clean Lenses	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.	Day 7, Day 30, Day 60, Day 90	No
Primary	Percentage of Subjects With Crystalline Deposits by Type	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.	Day 7, Day 30, Day 60, Day 90	No
Primary	Percentage of Subjects With Film Deposits by Type	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.	Day 7, Day 30, Day 60, Day 90	No
Primary	Average Residual Lens Lysozyme	Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 µg or 0 µg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.	Day 30/Early Exit	No
Primary	Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change	Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.	Baseline (Day 0), Day 7, Day 30, Day 60, Day 90	No
Primary	Average Lens Wear Time	Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours.	Day 7, Day 30, Day 60, Day 90	No
Primary	Number of Unscheduled Lens Replacements by Reason	A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.	Up to Day 90	No
Primary	Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."	Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.	Day 7, Day 30, Day 60, Day 90	No
Primary	Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."	Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.	Day 7, Day 30, Day 60, Day 90	Yes
Primary	Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."	Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.	Day 7, Day 30, Day 60, Day 90	No
Primary	Crystalline Deposit Area Covered	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.	Day 7, Day 30, Day 60, Day 90	No
Primary	Film Deposit Area Covered	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.	Day 7, Day 30, Day 60, Day 90	No