Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses

NCT01118338 | Completed Results

• 1 other identifier: 648
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.

Conditions

Myopia

Keywords

contact lens

Outcome Measures

Primary Outcomes (1)

• Symptoms and Complaints

  Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints and 100 denoting the most favorable rating. The generic scale was comprised of 14 separate questions, where each assessed the denoted symptom/complaint with a score between 0 and 100. The total score was not calculated.

  1 month

Secondary Outcomes (2)

• Visual Acuity

  1 month

• Percentage of Eyes With > Grade 2 Slit Lamp Findings

  1 month

Study Arms (2)

Redesigned Purevision Contact Lens

EXPERIMENTAL

Redesigned Bausch \& Lomb PureVision contact lens

Device: Redesigned Purevision Contact Lens

PureVision Contact Lens

ACTIVE COMPARATOR

Bausch \& Lomb PureVision contact lens

Device: PureVision Contact Lens

Interventions

Redesigned Purevision Contact Lens DEVICE

Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.

Redesigned Purevision Contact Lens

PureVision Contact Lens DEVICE

Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.

PureVision Contact Lens

Eligibility Criteria

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

You may qualify if:

• Subjects must have clear central corneas and be free of any anterior segment disorders.
• Subjects must be adapted wearers of one of the listed contact lenses
• Subjects must be myopic
• Subjects must use a lens care system on a regular basis.

You may not qualify if:

• Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.
• Subjects with any systemic disease affecting ocular health.
• 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 are using any ocular medication.
• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Subjects who have had any corneal surgery (eg, refractive surgery).
• Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb

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

• Gerard Cairns, MCOptom, 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: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2010
• First Posted: May 6, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 6, 2020
• Results First Posted: October 6, 2020

Record last verified: 2020-09

Locations

US (1)