Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: Redesigned Purevision Contact Lens; Device: PureVision Contact Lens

• Registration Number: NCT01118338
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-30
• Study Start: 2010-05
• Study First Submitted QC: 2010-05-05
• Study First Posted: 2010-05-06
• Primary Completion: 2010-06
• Study Completion: 2010-07
• Results First Submitted: 2020-08-21
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-11
• Last Update Submitted: 2020-09-11
• Results First Posted: 2020-10-06
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Redesigned Purevision Contact Lens	Redesigned Purevision Contact Lens	Redesigned Bausch \& Lomb PureVision contact lens
PureVision Contact Lens	PureVision Contact Lens	Bausch \& Lomb PureVision contact lens

Primary Outcome Measures

Name	Time	Method
Symptoms and Complaints	1 month	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Eyes With > Grade 2 Slit Lamp Findings	1 month	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.
Visual Acuity	1 month	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Trial Locations

Locations (1)

Bausch & Lomb; 🇺🇸 Rochester, New York, United States