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CompletedNCT00885092Updated Mar 27, 2012Results posted

Single Site Study of the Wettability of Contact Lenses With an Investigational Multi-Purpose Disinfecting Solution vs. a Marketed Multi-Purpose Solution

An interventional study of FID 114675A Multi-Purpose Disinfecting Solution (MPDS) and RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®) in Contact Lens Care, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-27.

Sponsored by Alcon Research · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Contact Lens Care

Keywords

  • Contact lenses
  • Disinfecting solutions
03

In context

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18 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).
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Other
    FID 114675A / RepleniSH

    FID 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.

    Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS) · Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®) · Device: Senofilcon A contact lens (ACUVUE® Oasys™) · Device: Balafilcon A contact lens (PureVision®)

  • Other
    RepleniSH / FID 114675A

    RepleniSH 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.

    Device: FID 114675A Multi-Purpose Disinfecting Solution (MPDS) · Device: RepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®) · Device: Senofilcon A contact lens (ACUVUE® Oasys™) · Device: Balafilcon A contact lens (PureVision®)

Interventions

  • DeviceFID 114675A Multi-Purpose Disinfecting Solution (MPDS)

    Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses.

  • DeviceRepleniSH Multi-Purpose Disinfecting Solution (MPDS) (OPTI-FREE® RepleniSH®)

    Commercially marketed solution intended for use as a cleaning, conditioning, rinsing, disinfecting, and storage solution for all silicone hydrogel and soft (hydrophilic) contact lenses.

    Also known as: (OPTI-FREE® RepleniSH®)

  • DeviceSenofilcon A contact lens (ACUVUE® Oasys™)

    Commercially marketed silicone hydrogel contact lens for daily wear use

    Also known as: ACUVUE® Oasys™

  • DeviceBalafilcon A contact lens (PureVision®)

    Commercially marketed silicone hydrogel contact lens for daily wear use

    Also known as: PureVision®

06

What researchers measure

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.

    Time frame: Day 7, Hour 14

Secondary outcomes

  1. Mean Lens Comfort

    Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, "My lenses feel comfortable right now," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.

    Time frame: Day 7, Hour 14

  2. Percentage of Participants With Solution-Related Corneal Staining

    Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes and is reported as a percentage of total participants.

    Time frame: Day 7, Hour 14

07

Results

Posted Mar 20, 2012

Participant flow

Participants were recruited from one US study center.

Period 1, 7 Days
Participant flow — Period 1, 7 Days
MilestoneFID 114675A / RepleniSHRepleniSH / FID 114675A
Started2020
Completed2020
Not completed00
Period 2, 7 Days
Participant flow — Period 2, 7 Days
MilestoneFID 114675A / RepleniSHRepleniSH / FID 114675A
Started2020
Completed2020
Not completed00

Outcome measures

PrimaryMean 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.

Time frame:
Day 7, Hour 14
Reported as:
Mean · Degrees
Mean Ex-Vivo Wetting Angle
DegreesFID 114675ARepleniSH
Mean Ex-Vivo Wetting Angle52.1 ± 32.759.6 ± 38.1
SecondaryMean Lens Comfort

Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, "My lenses feel comfortable right now," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree.

Time frame:
Day 7, Hour 14
Reported as:
Mean · Units on a scale
Mean Lens Comfort
Units on a scaleFID 114675ARepleniSH
Mean Lens Comfort4.1 ± 0.93.8 ± 0.9
SecondaryPercentage of Participants With Solution-Related Corneal Staining

Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes and is reported as a percentage of total participants.

Time frame:
Day 7, Hour 14
Reported as:
Number · Percentage of participants
Percentage of Participants With Solution-Related Corneal Staining
Percentage of participantsFID 114675ARepleniSH
Percentage of Participants With Solution-Related Corneal Staining00

Adverse events

Collected over Adverse events were collected for the duration of the study: 24 March 2009 to 5 May 2009.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
FID 114675A—0/40 (0%)0/40 (0%)
RepleniSH—0/40 (0%)0/40 (0%)

Baseline characteristics

Age Continuous
Age Continuous(years)FID 114675A / RepleniSHRepleniSH / FID 114675ATotal
Mean42.9 ± 10.142.4 ± 10.042.6 ± 10.0
Sex: Female, Male
Sex: Female, Male(Participants)FID 114675A / RepleniSHRepleniSH / FID 114675ATotal
Female121123
Male8917
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00885092
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Apr 21, 2009
Start date
Mar 2009
Primary completion
May 2009
Completion
May 2009
Results posted
Mar 20, 2012
Last update
Mar 27, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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