NCT00940459

Brief Summary

The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 16, 2016

Status Verified

July 1, 2012

Enrollment Period

3 months

First QC Date

July 14, 2009

Last Update Submit

November 15, 2016

Conditions

Contact Lenses

Keywords

contact lensesconjunctival stainingcontact lens wear

Outcome Measures

Primary Outcomes (1)

  • Circumlimbal Conjunctival Staining (CCS)

    After 10 days of wear

Study Arms (5)

Acuvue Oasys

EXPERIMENTAL

One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.

Device: Senofilcon A contact lens (Acuvue Oasys)Device: Contact lens care system (EasySept)

Biofinity

EXPERIMENTAL

One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.

Device: Comfilcon A contact lens (Biofinity)Device: Contact lens care system (EasySept)

Air Optix

EXPERIMENTAL

One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.

Device: Lotrafilcon B contact lens (Air Optix)Device: Contact lens care system (EasySept)

PureVision

EXPERIMENTAL

One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.

Device: Balafilcon A contact lens (PureVision)Device: Contact lens care system (EasySept)

Acuvue 2

ACTIVE COMPARATOR

One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.

Device: Etafilcon A contact lens (Acuvue 2)Device: Contact lens care system (EasySept)

Interventions

Senofilcon A contact lens (Acuvue Oasys)DEVICE

Silicone hydrogel contact lens CE-marked for the intended usage.

Also known as: ACUVUE® OASYS™
Acuvue Oasys
Comfilcon A contact lens (Biofinity)DEVICE

Silicone hydrogel contact lens CE-marked for the intended usage.

Also known as: Biofinity®
Biofinity
Lotrafilcon B contact lens (Air Optix)DEVICE

Silicone hydrogel contact lens CE-marked for the intended usage.

Also known as: Air Optix®
Air Optix
Balafilcon A contact lens (PureVision)DEVICE

Silicone hydrogel contact lens CE-marked for the intended usage.

Also known as: PureVision®
PureVision
Etafilcon A contact lens (Acuvue 2)DEVICE

Hydrogel contact lens CE-marked for the intended usage.

Also known as: ACUVUE® 2
Acuvue 2
Contact lens care system (EasySept)DEVICE

Contact lens care system CE-marked for the intended usage.

Also known as: EasySept
Acuvue 2Acuvue OasysAir OptixBiofinityPureVision

Eligibility Criteria

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

You may qualify if:

  • Minimum age of 18 years old
  • Adapted contact lens wearer
  • Sign informed consent
  • Normal eyes with the exception of the need for visual correction
  • Astigmatism less than or equal to -0.75 diopter
  • Spherical prescription range between -10.00 and +6.00 diopters

You may not qualify if:

  • Any known sensitivity to the test articles used in the study
  • Monocular vision
  • Lid or conjunctival infections or abnormalities
  • Conjunctival staining greater than Grade 1
  • Corneal staining greater than Grade 2
  • Corneal edema or opacifications
  • Aphakia
  • Any previous corneal surgery
  • Iritis
  • Recent significant changes in visual acuity
  • Ocular disease that contraindicates contact lens wear
  • Tarsal abnormalities greater than Grade 2
  • Any ophthalmic medication
  • Any systemic medication or condition that might affect the subject's participation in the study
  • Chronic upper respiratory infections or colds
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optometric Technology Group Ltd

London, United Kingdom

Location

Related Publications (1)

  • Maissa C, Guillon M, Garofalo RJ. Contact lens-induced circumlimbal staining in silicone hydrogel contact lenses worn on a daily wear basis. Eye Contact Lens. 2012 Jan;38(1):16-26. doi: 10.1097/ICL.0b013e31823bad46.

    PMID: 22146704RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 16, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 16, 2016

Record last verified: 2012-07

Locations

GB(1)