A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Investigational contact lens; Device: PureVision contact lens

• Registration Number: NCT01518868
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-24
• Study First Posted: 2012-01-26
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2020-08-21
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Results First Posted: 2020-09-30
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

• Have physiologically normal anterior segments
• Be adapted wearers of soft contact lenses and wear a lens in each eye.
• Be presbyopic and require near add correction in each eye.
• Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
• Have no active ocular disease or allergic conjunctivitis.
• Must not be using any topical ocular medications.
• Must habitually use a lens care product for lens cleaning, disinfecting, and storage.

Exclusion Criteria

• Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Anisometropia (spherical equivalent) of greater than 2.00 D.
• Any systemic disease affecting ocular health.
• Using any systemic or topical medications that will affect ocular physiology or lens performance.
• Allergic to any component in the study products.
• Ocular astigmatism of greater than 1.00 D in either eye.
• Have had any corneal surgery (ie, refractive surgery).
• Uses AMO Ultra Care as their habitual lens care regimen.
• Is a toric contact lens wearer.
• Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
• An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Investigational contact lens	Investigational contact lens	multifocal high add soft contact lens
PureVision contact lens	PureVision contact lens	Multi-focal contact lens

Primary Outcome Measures

Name	Time	Method
Visual Acuity	At 2 weeks follow up	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Secondary Outcome Measures

Name	Time	Method
Symptoms/Complaints	At 2 weeks follow up	Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.

Trial Locations

Locations (1)

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