Evaluation of Two Daily Disposable Contact Lenses.

NCT01300065 | Completed Results

• 1 other identifier: 642
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices (eg, Personal Digital Assistants \[PDAs\], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.

Conditions

Myopia

Keywords

contact lens

Outcome Measures

Primary Outcomes (1)

• Percentage of Eyes With > Grade 2 Slit Lamp Findings

  Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding \> grade 2, across abnormalities.

  2 weeks

Secondary Outcomes (1)

• Initial Lens Performance Survey

  At dispensing

Study Arms (2)

Experimental- Soflens

EXPERIMENTAL

Bausch \& Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution.

Device: Experimental- Soflens

Marketed - Soflens

ACTIVE COMPARATOR

Bausch \& Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution.

Device: Marketed - Soflens

Interventions

Experimental- Soflens DEVICE

A new pair of lenses will be worn each day while the subject is in the study

Experimental- Soflens

Marketed - Soflens DEVICE

A new pair of lenses will be worn each day while the subject is in the study.

Marketed - Soflens

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
• Subjects must be free of any anterior segment disorders.
• Subjects must be adapted soft contact lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
• Subjects must be myopic and require contact lens correction from -0.50 D to -6.00 D in each eye.
• Subjects must be willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study.
• Subjects must use a technologic device for an average of 4 hours per day over a week's time and at a minimum of 4 days per week.

You may not qualify if:

• Subjects 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.
• Subjects 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.
• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Subjects with an active ocular disease or who are using any ocular medication.
• Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Subjects with any scar or neovascularization within the central 4 mm of the cornea.
• Subjects who have had any corneal surgery (eg, refractive surgery).
• Subjects who are allergic to any component in the study care products.
• Subjects may not use their habitual rewetting drops while participating in this study.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

susan.harris@bauschhealth.com

908-300-9920

Study Officials

• Beverly J Barna, CCRA

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

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: February 21, 2011
• Study Start: January 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: October 6, 2020
• Results First Posted: October 6, 2020

Record last verified: 2020-09

Locations

US (1)