Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis

NCT02939950 | Completed Results

• 1 other identifier: 818
• Study Type: interventional
• Target: 816
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• High Contrast Visual Acuity

  For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters).

  Month 12

• Number of Participants With Adverse Events

  An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section.

  Baseline up to Month 12

Study Arms (2)

Bausch + Lomb Samfilcon A Soft Contact Lens

EXPERIMENTAL

Participants will wear Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month.

Device: Bausch + Lomb Samfilcon A Soft Contact Lens

Bausch + Lomb Pure Vision Soft Contact Lens

ACTIVE COMPARATOR

Participants will wear Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month.

Device: Bausch + Lomb Pure Vision Soft Contact Lens

Interventions

Bausch + Lomb Samfilcon A Soft Contact Lens DEVICE

soft contact lenses

Bausch + Lomb Samfilcon A Soft Contact Lens

Bausch + Lomb Pure Vision Soft Contact Lens DEVICE

soft contact lenses

Bausch + Lomb Pure Vision Soft Contact Lens

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
• Participants must be adapted lens wearers and wear a lens in each eye; each lens must be of the same manufacturer and brand.
• Participants must be myopic and require lens correction from -0.50 diopters (D) to 6.00 D in each eye.
• Participants must have clear central corneas and be free of any anterior segment disorders.
• Participants must agree to wear their lenses on an extended wear basis (6 nights/7 days) for the duration of the study.

You may not qualify if:

• Participants who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
• Participants with an active ocular disease or who are using any ocular medication.
• Participants with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
• Participants using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Participants who are not correctable to 42 letters (0.1 logMAR) in each eye with soft spherical contact lenses.
• Participants who currently wear monovision, multifocal, or toric contact lenses.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Cicero Family Eye Care

Cicero, New York, 13039, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Bausch Health Americas, Inc.

Daniel.Donatello@bausch.com

(585) 338-5306

Study Officials

• Johnson Varughese

  Bausch Health Americas, Inc.

  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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: October 20, 2016
• Study Start: April 30, 2015
• Primary Completion: August 3, 2016
• Study Completion: August 3, 2016
• Last Updated: December 23, 2019
• Results First Posted: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)