Mucin Balls and Corneal Inflammation Events
This study is currently recruiting participants.
Verified March 2013 by Vistakon
Sponsor:
Vistakon
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01437319
First received: September 16, 2011
Last updated: March 29, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 7 Days Post Randomization [ Time Frame: Post Randomization at 7 days ] [ Designated as safety issue: No ]The presence and number of Corneal Inflammatory Events at each visit.
- Corneal Inflammatory Events Post 7 Days Randomization to One Month [ Time Frame: Post Randomization at 1 month ] [ Designated as safety issue: No ]The presence and number of Corneal Inflammatory Events at each visit.
- Corneal Inflammatory Events Post 1 Month Randomization to 4 Months [ Time Frame: Post Randomization at 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 Post 8 Months Randomization to 12 Months [ Time Frame: Post Randomization at 12 months ] [ Designated as safety issue: No ]The presence and number of Corneal Inflammatory Events at each visit.
| Estimated Enrollment: | 287 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | May 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01437319
Contacts
| Contact: Tawnya Wilson, OD | 1-904-443-1834 | twilson@its.jnj.com |
Locations
| United States, Ohio | |
| Recruiting | |
| Beachwood, Ohio, United States | |
| Recruiting | |
| Cleveland, Ohio, United States | |
| Recruiting | |
| 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: | March 29, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Inflammation Keratitis Pathologic Processes Corneal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013