How effective are anti-bacterial contact lens storage cases?

Phase 4

• Conditions: Eye - Diseases / disorders of the eye; Contact Lens Storage Case Contamination

• Registration Number: ACTRN12619001520123
• Lead Sponsor: CooperVision Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age 18 years or older at the time of screening.
2. Be a current frequent replacement soft contact lens wearer (hydrogel or silicone hydrogel)
3. Be willing to wear the contact lenses on a daily wear basis for a minimum of 4 days per week for the duration of the study and follow standard contact lens practice and precautions during lens wear
4. Be willing to use the study prescribed contact lens cleaning and disinfection solution and lens storage case for the duration of the study

Exclusion Criteria

1. Daily disposable or extended wear soft contact lens wearer
2. Rigid gas permeable lens wearer (including orthokeratology).
3. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
4. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
5. Any ocular abnormalities such as entropion, ectropion, extrusions, chalazia, recurrent styes, history of recurrent corneal erosions.
6. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrolment.
8. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
9. Be currently pregnant or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the proportion (percentage) of silver (test) and non-silver (control) contact lens storage cases contamined with bacteria. One-month used contact lens storage cases will be sent to the microbiology laboratory within one hour of collection. An unmasked researcher will swab the lens case wells using a sterile cotton swab and culture the bacteria using standard microbial culture techniques. [Visit 1: Baseline<br>Visit 2: 1 months after Visit 1<br>Visit 3: 2 months after Visit 2<br>Visit 4: 1 month after Visit 3<br>Visit 5: 2 months after Visit 4];To identify the types of micro-organisms recovered from silver-impregnated (test) and non-silver (control) contact lens storage cases. Following bacterial culture of the contact lens storage case wells, bacteria will be identified using standard biochemical methods.[Visit 1: Baseline<br>Visit 2: 1 months after Visit 1<br>Visit 3: 2 months after Visit 2<br>Visit 4: 1 month after Visit 3<br>Visit 5: 2 months after Visit 4]

Secondary Outcome Measures

Name	Time	Method
one[None]