A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses

NCT01309867 | Completed Results

• 1 other identifier: 680
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees.

  2 weeks

• Visual Acuity

  Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

  2 weeks

Secondary Outcomes (2)

• Symptoms and Complaints

  2 weeks

• Percentage of Eyes With > Grade 2 Slit Lamp Findings

  2 weeks

Study Arms (2)

Investigational Toric Lens

EXPERIMENTAL

Bausch + Lomb investigational toric contact lenses

Device: Investigational Toric Lens

PureVision Toric Lens

ACTIVE COMPARATOR

Currently marketed Bausch + Lomb PureVision toric contact lenses

Device: PureVision Toric Lens

Interventions

Investigational Toric Lens DEVICE

Bausch \& Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.

Investigational Toric Lens

PureVision Toric Lens DEVICE

Currently marked Bausch \& Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.

PureVision Toric Lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand.
• Subjects must be myopic and require lens correction
• Subjects must be habitual wearers of toric soft contact lenses.

You may not qualify if:

• 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 any grade 2 or greater finding during the slit lamp examination. 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 who are allergic to any component in the study care products.

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

robert.steffen@bausch.com

585-338-6399

Study Officials

• Beverly Barna

  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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 7, 2011
• Study Start: December 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: April 1, 2011
• Last Updated: October 8, 2020
• Results First Posted: October 8, 2020

Record last verified: 2020-10

Locations

US (1)