NCT01197859

Brief Summary

The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

September 2, 2010

Last Update Submit

August 10, 2020

Conditions

Vision Correction

Outcome Measures

Primary Outcomes (1)

  • Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy.

    The clinical study will assess the following performance variables as compared to the predicate device during 5 follow-up visits over a 3 month period to demonstrate safety and efficacy: Sphere-cyl Refraction and VA, Keratometry, Comfort, Handling, Symptoms, Over-Refraction and VA, Lens Fit, Lens Deposits, and Slit Lamp Findings.

    3 months

Study Arms (2)

Contamac 74% silicone hydrogel contact lens

ACTIVE COMPARATOR

Definitive Contact Lens

Device: Definitive Contact Lens

Cooper Vision Biofinity

PLACEBO COMPARATOR

Biofinity Contact Lens

Device: Biofinity

Interventions

Definitive Contact LensDEVICE

Daily wear contact lens

Contamac 74% silicone hydrogel contact lens
BiofinityDEVICE

Daily wear contact lens

Cooper Vision Biofinity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • existing contact lens wearer
  • read and signed statement of informed consent
  • has clear central cornea
  • requires spherical distance correction

You may not qualify if:

  • has worn RGP contact lenses within the last 30 days
  • is using any ocular medication
  • has had refractive surgery
  • has an infectious disease
  • is pregnant or lactating
  • is participating in another clinical research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vision Care Research

Farnham, Surry, GU9 7EN, United Kingdom

Location

Study Officials

  • Graeme Young

    Vision Care Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2010

First Posted

September 9, 2010

Study Start

August 1, 2008

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

August 12, 2020

Record last verified: 2020-08

Locations

GB(1)