Mucin Balls and Corneal Inflammation Events

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01437319
• Date of registration: 16/09/2011
• Primary sponsor: Vistakon
• Public title: Mucin Balls and Corneal Inflammation Events
• Date of first enrolment: September 2011
• Target sample size: 287
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01437319
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: Tawnya Wilson, OD

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Corneal Inflammation

Intervention(s)

Device: balafilcon A

Device: comfilcon A

Device: lotrafilcon A

Primary Outcome(s)

Corneal Inflammatory Events 7 Days Post Randomization [Time Frame: Post Randomization at 7 days]

Corneal Inflammatory Events Post 1 Month Randomization to 4 Months [Time Frame: Post Randomization at 4 months]

Corneal Inflammatory Events Post 4 Months Randomization to 8 Months [Time Frame: Post Randomization at 8 months]

Corneal Inflammatory Events Post 7 Days Randomization to One Month [Time Frame: Post Randomization at 1 month]

Corneal Inflammatory Events Post 8 Months Randomization to 12 Months [Time Frame: Post Randomization at 12 months]

Secondary ID(s)

CR-005016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors