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

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ClinicalTrials.gov Identifier: NCT00889252
Recruitment Status : Completed
First Posted : April 28, 2009
Results First Posted : November 23, 2010
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Vistakon Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Allergic Conjunctivitis
Interventions Device: contact lens with ketotifen
Device: contact lens
Enrollment 250
Recruitment Details  
Pre-assignment Details  
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug contact lens without drug
Period Title: Overall Study
Started 168 82
Completed 161 78
Not Completed 7 4
Reason Not Completed
Adverse Event             2             4
Withdrawal by Subject             3             0
Protocol Violation             2             0
Arm/Group Title K-Lens Placebo Lens Total
Hide Arm/Group Description Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug contact lens without drug Total of all reporting groups
Overall Number of Baseline Participants 168 82 250
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 168 participants 82 participants 250 participants
32.6  (12.48) 29.3  (10.77) 31.5  (12.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 82 participants 250 participants
Female
117
  69.6%
46
  56.1%
163
  65.2%
Male
51
  30.4%
36
  43.9%
87
  34.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 168 participants 82 participants 250 participants
168 82 250
1.Primary Outcome
Title Lid and Lid Margin Erythema, Change From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0) 0  (0)
2.Primary Outcome
Title Lid and Lid Margin Swelling, Change From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0) 0  (0)
3.Primary Outcome
Title Conjunctival Redness, Change From Baseline
Hide Description Assessment of conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.3  (0.67) -0.1  (0.58)
4.Primary Outcome
Title Conjunctival Chemosis, Change From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0) 0  (0)
5.Primary Outcome
Title Corneal Edema, Change From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0) 0  (0)
6.Primary Outcome
Title Corneal Erosion, Change From Baseline
Hide Description Assessment of corneal erosion using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0) 0  (0)
7.Primary Outcome
Title Corneal Endothelial, Change From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0) 0  (0)
8.Primary Outcome
Title Lens Pathology, Change From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.23) 0  (0.20)
9.Primary Outcome
Title Flare in Anterior Chamber, Change From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0) 0  (0)
10.Primary Outcome
Title Cells in Anterior Chamber, Change From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0) 0  (0)
11.Primary Outcome
Title Corneal Staining - Nasal, Change From Baseline
Hide Description Assessment of changes to the surface of the 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.27) 0  (0.24)
12.Primary Outcome
Title Corneal Staining - Temporal, Change From Baseline
Hide Description Assessment of changes to the surface of the cornea, the region towards the 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.20) 0  (0.22)
13.Primary Outcome
Title Corneal Staining - Inferior, Change From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.1  (0.51) 0.0  (0.43)
14.Primary Outcome
Title Corneal Staining - Superior, Change From Baseline
Hide Description Assessment of changes to the surface of the cornea, the 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.13) 0  (0)
15.Primary Outcome
Title Corneal Staining - Central, Change From Baseline
Hide Description Assessment of changes to the surface of the cornea, the 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.19) 0  (0.19)
16.Primary Outcome
Title Intraocular Pressure - Change From Baseline
Hide Description [Not Specified]
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: mm of mercury
0.8  (2.45) 0.6  (2.51)
17.Primary Outcome
Title Dilated Ophthalmoscopy - Fundus, Change From Baseline
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0) 0  (0)
18.Primary Outcome
Title Dilated Ophthalmoscopy - Vitreous, Change From Baseline
Hide Description Assessment of changes in the vitreous (gel-like fulid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.
Time Frame baseline and 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0) 0  (0)
19.Primary Outcome
Title Visual Acuity Assessment
Hide Description 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 the 12 week visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis.
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description:
Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
contact lens without drug
Overall Number of Participants Analyzed 158 75
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
316 150
Measure Type: Number
Unit of Measure: Eyes
316 150
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title K-Lens Placebo Lens
Hide Arm/Group Description Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug contact lens without drug
All-Cause Mortality
K-Lens Placebo Lens
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
K-Lens Placebo Lens
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/168 (0.60%)      0/82 (0.00%)    
Gastrointestinal disorders     
Cholelithiasis * [1]  1/168 (0.60%)  1 0/82 (0.00%) 
Reproductive system and breast disorders     
Benign adenoma * [2]  1/168 (0.60%)  1 0/82 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
Gallstones, unrelated to test article.
[2]
Benign tumor on an ovary, unrelated to test article.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
K-Lens Placebo Lens
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/168 (7.14%)      0/82 (0.00%)    
Eye disorders     
Instillation Site Irritation *  12/168 (7.14%)  0/82 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator agrees not to publish or publicly present the results of the study without the prior written approval of the sponsor.
Results Point of Contact
Name/Title: Brian Pall OD MS FAAO
Organization: Vistakon
Phone: 904-443-1290
Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00889252     History of Changes
Other Study ID Numbers: CR-4539
First Submitted: April 24, 2009
First Posted: April 28, 2009
Results First Submitted: October 4, 2010
Results First Posted: November 23, 2010
Last Update Posted: March 6, 2015