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

NCT01518868 | Completed Results

• 1 other identifier: 743E
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

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

  At 2 weeks follow up

Secondary Outcomes (1)

• Symptoms/Complaints

  At 2 weeks follow up

Study Arms (2)

Investigational contact lens

EXPERIMENTAL

multifocal high add soft contact lens

Device: Investigational contact lens

PureVision contact lens

ACTIVE COMPARATOR

Multi-focal contact lens

Device: PureVision contact lens

Interventions

Investigational contact lens DEVICE

Worn on a daily wear basis for one week.

Investigational contact lens

PureVision contact lens DEVICE

Worn on a daily wear basis for one week

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb, Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

robert.steffen@bausch.com

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: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 26, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: September 30, 2020
• Results First Posted: September 30, 2020

Record last verified: 2020-09

Locations

US (1)