Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution
Wettability of Silicone Hydrogel Lenses With SiH MPDS FID 114675A vs. A Marketed Multi-Purpose Solution
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The purpose of this study is to clinically evaluate an investigational multi-purpose disinfecting solution (MPDS) compared to a commercial MPDS with respect to wettability of silicone hydrogel contact lenses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2009
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 17, 2009
CompletedFirst Posted
Study publicly available on registry
April 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
March 20, 2012
CompletedMarch 27, 2012
March 1, 2012
2 months
April 17, 2009
February 24, 2012
March 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Ex-Vivo Wetting Angle
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Day 7, Hour 14
Secondary Outcomes (2)
Mean Lens Comfort
Day 7, Hour 14
Percentage of Participants With Solution-Related Corneal Staining
Day 7, Hour 14
Study Arms (2)
FID 114675A / RepleniSH
OTHERFID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
RepleniSH / FID 114675A
OTHERRepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
Interventions
Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.
Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.
Commercially marketed silicone hydrogel contact lens for daily wear use
Commercially marketed silicone hydrogel contact lens for daily wear use
Eligibility Criteria
You may qualify if:
- years of age or older.
- Must be successfully wearing assigned study lens brand (either ACUVUE® OASYS™ or PureVision® contact lenses) for at least 7-10 days, minimum 8 hours a day, prior to Visit 1 (screening).
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1 (screening).
- Must have discontinued contact lens wear for at least two consecutive days before Visit 2 (baseline).
You may not qualify if:
- Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude safe administration of test article or safe participation in the study.
- Known sensitivity or intolerance to any protocol-specified contact lens solutions, eye drops, or products containing similar ingredients (e.g., generic products).
- Monocular vision (only one eye with functional vision) or fit with only one contact lens.
- Use of topical ocular over-the-counter or prescribed topical ocular medication, with the exception of rewetting drops, within 7 days prior to screening visit.
- Current or history of ocular infection, inflammation, disease, structural abnormality or conditions within the last 6 months that could affect study participation or may preclude safe administration of the investigational lens care solution, in the opinion of the investigator.
- Any corneal surgery, cataract surgery, intraocular lens implants or glaucoma filtering surgery within the last 12 months.
- Any slit-lamp finding score of 1 (or rated 3 or 4 for limbal and bulbar conjunctival injection) at screening or baseline visits.
- Corneal staining area assessment ≥ 20% in any corneal region in either eye at screening or baseline visit.
- Corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye at baseline visit.
- Participation in any investigational clinical study within 30 days of baseline visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Results Point of Contact
- Title
- Director of Alcon Clinical
- Organization
- Alcon Research, Ltd.
Publication Agreements
- PI is Sponsor Employee
- Yes
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
April 17, 2009
First Posted
April 21, 2009
Study Start
March 1, 2009
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
March 27, 2012
Results First Posted
March 20, 2012
Record last verified: 2012-03