Allergic ConjunctivitisPhase 3NCT00569777
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
A Phase 3 study testing K-Lens (generic name not established) and Ketotifen in people with Allergic Conjunctivitis, run by Vistakon Pharmaceuticals at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- K-Lens (generic name not established) and Ketotifen
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2007to Mar 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- active ocular infection
- history of ocular surgery
- use of topical ophthalmic preparations (including rewetting drops)
- pregnancy or lactation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Gardena, California, 90247
Study site
Memphis, Tennessee, 38119
Study site
North Andover, Massachusetts, 01845
About this study
Official title: A Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Evaluating the Safety of a Novel Contact Lens Used Daily in Healthy, Normal Volunteers
The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers
- Conditions
- Allergic Conjunctivitis
- Being tested
- K-Lens (generic name not established) and Ketotifen, Placebo Lens
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-Lens (generic name not established) and KetotifenDevice
combination drug-device product: contact lens (device) and anti-allergy drug
Placebo LensDevice
contact lens without drug
| Study group | Role | What they receive |
|---|---|---|
| K-lens | Experimental | etafilcon A contact lens with ketotifen. Receives: Device: K-Lens (generic name not established) and Ketotifen |
| Placebo | Placebo comparator | etafilcon A contact lens without ketotifen Receives: Device: Placebo Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
Corneal Edema, Change From Baseline
Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Measured: baseline and 12 weeks
Corneal Erosion, Change From Baseline
Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
Intraocular Pressure, Change From Baseline
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
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.
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergic ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vistakon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Pall, OD, MS, FAAO, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569777
- Sponsor's protocol ID
- 07-003-002
- Status last verified
- Feb 2015
- First submitted
- 27 Nov 2007
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Evaluating the Safety of a Novel Contact Lens Used Daily in Healthy, Normal Volunteers
- ClinicalTrials.gov ID
- NCT00569777
- Acronym / sponsor ID
- 07-003-002
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Vistakon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 7 Dec 2007 (estimated)
- Results
- Posted 23 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K-lens | Experimental | Device: K-Lens (generic name not established) and Ketotifenetafilcon A contact lens with ketotifen. |
| Placebo | Placebo comparator | Device: Placebo Lensetafilcon A contact lens without ketotifen |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- active ocular infection
- history of ocular surgery
- use of topical ophthalmic preparations (including rewetting drops)
- pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K-Lens (generic name not established) and Ketotifencombination drug-device product: contact lens (device) and anti-allergy drug | Device | K-lens |
| Placebo Lenscontact lens without drug | Device | Placebo |
Primary outcome
Lid and Lid Margin Erythema, Change From Baseline
Time frame: baseline and 12 weeks
Assessment of lid redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Lid and Lid Margin Swelling, Change From Baseline
Time frame: baseline and 12 weeks
Assessment of lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Conjunctival Redness, Change From Baseline
Time frame: baseline and 12 weeks
Assessment of redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Conjunctival Chemosis, Change From Baseline
Time frame: baseline and 12 weeks
Assessment of swelling of the conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Corneal Edema, Change From Baseline
Time frame: baseline and 12 weeks
Assessment of corneal swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Corneal Erosion, Change From Baseline
Time frame: baseline and 12 weeks
Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe.
Corneal Endothelial, Change From Baseline
Time frame: baseline and 12 weeks
Assessment of the posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Lens Pathology, Change From Baseline
Time frame: baseline and 12 weeks
Assessment of the clarity of the intraocular lens using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Flare in Anterior Chamber, Change From Baseline
Time frame: baseline and 12 weeks
Assessment of visible protein in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Cells in Anterior Chamber, Change From Baseline
Time frame: baseline and 12 weeks
Assessment of visible cells in the anterior chamber using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Corneal Staining - Nasal, Change From Baseline
Time frame: baseline and 12 weeks
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.
Corneal Staining - Temporal, Change From Baseline
Time frame: baseline and 12 weeks
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.
Corneal Staining - Inferior, Change From Baseline
Time frame: baseline and 12 weeks
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.
Corneal Staining - Superior, Change From Baseline
Time frame: baseline and 12 weeks
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.
Corneal Staining - Central, Change From Baseline
Time frame: baseline and 12 weeks
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.
Intraocular Pressure, Change From Baseline
Time frame: baseline and 12 weeks
Dilated Ophthalmoscopy - Fundus, Change From Baseline
Time frame: baseline and 12 weeks
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.
Dilated Ophthalmoscopy - Vitreous, Change From Baseline
Time frame: baseline and 12 weeks
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.
Visual Acuity Assessment
Time frame: at 12 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Pall, OD, MS, FAAO study director
Johnson & Johnson Vision Care, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing K-Lens (generic name not established) and Ketotifen in people with Allergic Conjunctivitis, run by Vistakon Pharmaceuticals at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lid and Lid Margin Erythema, Change From Baseline (time frame: baseline and 12 weeks). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.