Mucin Balls and Corneal Inflammation Events

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01437319
First received: September 16, 2011
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to determine if the formation of mucin balls is a marker for protection from inflammatory events to the cornea and if mucin balls play a role in protection during extended contact lens wear.


Condition Intervention
Corneal Inflammation
Device: lotrafilcon A
Device: comfilcon A
Device: balafilcon A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Corneal Inflammatory Events [ Time Frame: Number of events from baseline to 7 days ] [ Designated as safety issue: No ]
    The presence and number of Corneal Inflammatory Events at each visit.

  • Corneal Inflammatory Events [ Time Frame: Number of events 7 Days post randomization to one month ] [ Designated as safety issue: No ]
    The presence and number of Corneal Inflammatory Events at each visit.

  • Corneal Inflammatory Events [ Time Frame: Number of events 1 month post randomization to 4 months ] [ Designated as safety issue: No ]
    The presence and number of Corneal Inflammatory Events at each visit.

  • Corneal Inflammatory Events Post 4 Months Randomization to 8 Months [ Time Frame: Post Randomization at 8 months ] [ Designated as safety issue: No ]
    The presence and number of Corneal Inflammatory Events at each visit.

  • Corneal Inflammatory Events [ Time Frame: Number of events 8 months post randomization to 12 months ] [ Designated as safety issue: No ]
    The presence and number of Corneal Inflammatory Events at each visit.


Enrollment: 287
Study Start Date: September 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lotrafilcon A, comfilcon A
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to comfilcon A at phase 2.
Device: lotrafilcon A
To be used during run-in phase only.
Device: comfilcon A
To be assigned at randomization at phase 2 only.
Active Comparator: lotrafilcon A, balafilcon A
All subjects are assigned to lotrafilcon A during a run-in (Phase 1) and then randomized to one of two lenses. This arm is assigned to balafilcon A at phase 2.
Device: lotrafilcon A
To be used during run-in phase only.
Device: balafilcon A
To be assigned at randomization during phase 2 only.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years
  • Free of any active anterior segment disorders that would preclude safe contact lens wear. Active anterior segment disorders and evidence of central microbial keratitis (via a large, >1mm central deep stromal scar) are not allowed. However, evidence of past CLPU will be allowed so long as no more then three such scars are detected bilaterally. Evidence of more than 3 CLPU-like scars places excessive risk on the subject for a subsequent CIE.
  • Correctable vision to 20/25 or better in each eye with spectacles. Amblyopia will be excluded.
  • Flat and steep corneal curvatures from keratometry readings must be between 39.00 and 48.50 D, respectively.
  • Own or agree to purchase a pair of spectacles that can be worn when lenses are removed or in cases of ocular discomfort or emergency.
  • Correctable vision to 20/30 or better at distance with dispensed contact lenses.

Exclusion Criteria:

  • Use/wear of rigid gas permeable lenses within the last 30 days or PMMA lenses within the last 3 months.
  • Immunocompromising disease or insulin dependent diabetes or any other systemic disease that in the investigator's opinion will affect ocular health or increase risk during extended wear.
  • Chronic use of systemic corticosteroids (with the exception of corticosteroid inhalers) or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
  • Ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
  • Use of any ocular medications in the last 2 weeks.
  • Less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales.
  • Currently pregnant or lactating.
  • Smoker
  • Swimming routine of more than twice per month.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437319

Locations
United States, Ohio
Beachwood, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01437319     History of Changes
Other Study ID Numbers: CR-005016
Study First Received: September 16, 2011
Last Updated: August 18, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammation
Keratitis
Corneal Diseases
Eye Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014