CClinicalTrials.gg
Sign In
CompletedNCT00569777Updated Mar 6, 2015Results posted

Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers

A Phase 3 interventional study of K-Lens (generic name not established) and Ketotifen and Placebo Lens in Allergic Conjunctivitis, sponsored by Vistakon Pharmaceuticals. Completed at 3 sites in United States. Open to participants aged 8 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by Vistakon Pharmaceuticals · Phase 3, Interventional, and Basic science

Phase
Phase 3
Study type
Interventional
Enrollment
310
Allocation
Randomized
Ages
8 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers

02

Conditions studied

  • Allergic Conjunctivitis
03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 310 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Vistakon Pharmaceuticals is the lead sponsor of 12 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
8 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy normal, soft contact lens wearing volunteers
  • normal ocular health
  • contact lens correction from +6.00 to -12.00D in each eye and astigmatism of -1.00D or less in each eye

Exclusion criteria

Exclusion Criteria:

  • active ocular infection
  • history of ocular surgery
  • use of topical ophthalmic preparations (including rewetting drops)
  • pregnancy or lactation
05

Study design

Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
310 participants (actual)

Study arms

  • Experimental
    K-lens

    etafilcon A contact lens with ketotifen.

    Device: K-Lens (generic name not established) and Ketotifen

  • Placebo comparator
    Placebo

    etafilcon A contact lens without ketotifen

    Device: Placebo Lens

Interventions

  • DeviceK-Lens (generic name not established) and Ketotifen

    combination drug-device product: contact lens (device) and anti-allergy drug

  • DevicePlacebo Lens

    contact lens without drug

06

What researchers measure

Primary outcomes

  1. Lid and Lid Margin Erythema, Change From Baseline

    Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  2. Lid and Lid Margin Swelling, Change From Baseline

    Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  3. Conjunctival Redness, Change From Baseline

    Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  4. Conjunctival Chemosis, Change From Baseline

    Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  5. Corneal Edema, Change From Baseline

    Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  6. Corneal Erosion, Change From Baseline

    Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.

    Time frame: baseline and 12 weeks

  7. Corneal Endothelial, Change From Baseline

    Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  8. Lens Pathology, Change From Baseline

    Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  9. Flare in Anterior Chamber, Change From Baseline

    Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  10. Cells in Anterior Chamber, Change From Baseline

    Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  11. Corneal Staining - Nasal, Change From Baseline

    Assessment of changes to the surface of cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  12. Corneal Staining - Temporal, Change From Baseline

    Assessment of changes to the surface of the cornea, the region towards the outer edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  13. Corneal Staining - Inferior, Change From Baseline

    Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  14. Corneal Staining - Superior, Change From Baseline

    Assessment of changes to the surface of the cornea, upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  15. Corneal Staining - Central, Change From Baseline

    Assessment of changes to the surface of the cornea, central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

    Time frame: baseline and 12 weeks

  16. Intraocular Pressure, Change From Baseline

    Time frame: baseline and 12 weeks

  17. Dilated Ophthalmoscopy - Fundus, Change From Baseline

    Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.

    Time frame: baseline and 12 weeks

  18. Dilated Ophthalmoscopy - Vitreous, Change From Baseline

    Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.

    Time frame: baseline and 12 weeks

  19. Visual Acuity Assessment

    Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.

    Time frame: at 12 weeks

07

Results

Posted Nov 23, 2010

Participant flow

Participant flow — Overall Study
MilestoneK-lensPlacebo
Started206104
Completed196101
Not completed103
Withdrew: Withdrawal by subject40
Withdrew: Adverse event30
Withdrew: Lost to follow-up10
Withdrew: Scheduled eye surgery01
Withdrew: Did not meet exclusion criteria12
Withdrew: Pregnant10

Outcome measures

PrimaryLid and Lid Margin Erythema, Change From Baseline

Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Lid and Lid Margin Erythema, Change From Baseline
Units on a scaleK-lensPlacebo
Lid and Lid Margin Erythema, Change From Baseline0 ± 0.0530 ± 0.129
PrimaryLid and Lid Margin Swelling, Change From Baseline

Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Lid and Lid Margin Swelling, Change From Baseline
Units on a scaleK-lensPlacebo
Lid and Lid Margin Swelling, Change From Baseline0 ± 00 ± 0
PrimaryConjunctival Redness, Change From Baseline

Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Conjunctival Redness, Change From Baseline
Units on a scaleK-lensPlacebo
Conjunctival Redness, Change From Baseline0 ± 0.632-0.1 ± 0.522
PrimaryConjunctival Chemosis, Change From Baseline

Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Conjunctival Chemosis, Change From Baseline
Units on a scaleK-lensPlacebo
Conjunctival Chemosis, Change From Baseline0 ± 0.1050 ± 0.166
PrimaryCorneal Edema, Change From Baseline

Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Corneal Edema, Change From Baseline
Units on a scaleK-lensPlacebo
Corneal Edema, Change From Baseline0 ± 00 ± 0
PrimaryCorneal Erosion, Change From Baseline

Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Corneal Erosion, Change From Baseline
Units on a scaleK-lensPlacebo
Corneal Erosion, Change From Baseline0 ± 00 ± 0.106
PrimaryCorneal Endothelial, Change From Baseline

Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Corneal Endothelial, Change From Baseline
Units on a scaleK-lensPlacebo
Corneal Endothelial, Change From Baseline0 ± 00 ± 0
PrimaryLens Pathology, Change From Baseline

Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Lens Pathology, Change From Baseline
Units on a scaleK-lensPlacebo
Lens Pathology, Change From Baseline0 ± 0.181-0.1 ± 0.254
PrimaryFlare in Anterior Chamber, Change From Baseline

Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Flare in Anterior Chamber, Change From Baseline
Units on a scaleK-lensPlacebo
Flare in Anterior Chamber, Change From Baseline0 ± 00 ± 0
PrimaryCells in Anterior Chamber, Change From Baseline

Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Cells in Anterior Chamber, Change From Baseline
Units on a scaleK-lensPlacebo
Cells in Anterior Chamber, Change From Baseline0 ± 00 ± 0
PrimaryCorneal Staining - Nasal, Change From Baseline

Assessment of changes to the surface of cornea, the region towards the nose, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Corneal Staining - Nasal, Change From Baseline
Units on a scaleK-lensPlacebo
Corneal Staining - Nasal, Change From Baseline-0.1 ± 0.280 ± 0.35
PrimaryCorneal Staining - Temporal, Change From Baseline

Assessment of changes to the surface of the cornea, the region towards the outer edge of the face, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Corneal Staining - Temporal, Change From Baseline
Units on a scaleK-lensPlacebo
Corneal Staining - Temporal, Change From Baseline0 ± 0.2710 ± 0.256
PrimaryCorneal Staining - Inferior, Change From Baseline

Assessment of changes to the surface of the cornea, the bottom region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Corneal Staining - Inferior, Change From Baseline
Units on a scaleK-lensPlacebo
Corneal Staining - Inferior, Change From Baseline0 ± 0.5150 ± 0.53
PrimaryCorneal Staining - Superior, Change From Baseline

Assessment of changes to the surface of the cornea, upper region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Corneal Staining - Superior, Change From Baseline
Units on a scaleK-lensPlacebo
Corneal Staining - Superior, Change From Baseline0 ± 0.2290 ± 0.149
PrimaryCorneal Staining - Central, Change From Baseline

Assessment of changes to the surface of the cornea, central region, as evaluated by the degree of staining with sodium fluorescein solution, using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Corneal Staining - Central, Change From Baseline
Units on a scaleK-lensPlacebo
Corneal Staining - Central, Change From Baseline0 ± 0.2340 ± 0.212
PrimaryIntraocular Pressure, Change From Baseline
Time frame:
baseline and 12 weeks
Reported as:
Mean · mm of mercury
Intraocular Pressure, Change From Baseline
mm of mercuryK-lensPlacebo
Intraocular Pressure, Change From Baseline-0.3 ± 2.7-0.4 ± 2.707
PrimaryDilated Ophthalmoscopy - Fundus, Change From Baseline

Assessment of changes in abnormalities on the back part of the eye, using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Dilated Ophthalmoscopy - Fundus, Change From Baseline
Units on a scaleK-lensPlacebo
Dilated Ophthalmoscopy - Fundus, Change From Baseline-0.1 ± 0.3710 ± 0.235
PrimaryDilated Ophthalmoscopy - Vitreous, Change From Baseline

Assessment of changes in the vitreous (gel-like fluid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.

Time frame:
baseline and 12 weeks
Reported as:
Mean · Units on a scale
Dilated Ophthalmoscopy - Vitreous, Change From Baseline
Units on a scaleK-lensPlacebo
Dilated Ophthalmoscopy - Vitreous, Change From Baseline0 ± 0.1490 ± 0.149
PrimaryVisual Acuity Assessment

Visual acuity was assessed by the investigator using a Snellen visual acuity chart. This outcome counts the number of eyes that had vision of 20/40 or better at the 12 week visit.

Time frame:
at 12 weeks
Reported as:
Number · Eyes
Visual Acuity Assessment
EyesK-lensPlacebo
Visual Acuity Assessment362178

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
K-lens—2/206 (1%)11/206 (5.3%)
Placebo—0/104 (0%)4/104 (3.8%)
Most frequent serious events
Most frequent serious events
EventK-lensPlacebo
nasal fractureInjury, poisoning and procedural complications1/2060/104
abdominal discomfort requiring hospitalizationGastrointestinal disorders1/2060/104
Most frequent other events
Most frequent other events
EventK-lensPlacebo
nasopharyngitisInfections and infestations11/2064/104

Baseline characteristics

Age, Continuous
Age, Continuous(years)K-lensPlaceboTotal
Mean31 ± 11.6230 ± 10.7531 ± 11.33
Sex: Female, Male
Sex: Female, Male(Participants)K-lensPlaceboTotal
Female14480224
Male622486
Region of Enrollment
Region of Enrollment(participants)K-lensPlaceboTotal
United States206104310
08

Study locations

3 sites
  • Gardena, California 90247, United States
  • North Andover, Massachusetts 01845, United States
  • Memphis, Tennessee 38119, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00569777
Lead sponsor
Vistakon Pharmaceuticals
Responsible party
Sponsor
First posted
Dec 7, 2007
Start date
Oct 2007
Primary completion
Feb 2008
Completion
Mar 2008
Results posted
Nov 23, 2010
Last update
Mar 6, 2015

Study contacts

Brian Pall, OD, MS, FAAO
study director · Johnson & Johnson Vision Care, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Conjunctivitis→

Other studies from this sponsor

Vistakon Pharmaceuticals

Start the discussion