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Trial record 2 of 5 for:    ketotifen contact lens

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

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ClinicalTrials.gov Identifier: NCT00569777
Recruitment Status : Completed
First Posted : December 7, 2007
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: Basic Science
Condition Allergic Conjunctivitis
Interventions Device: K-Lens (generic name not established) and Ketotifen
Device: Placebo Lens
Enrollment 310
Recruitment Details  
Pre-assignment Details  
Arm/Group Title K-lens Placebo
Hide Arm/Group Description etafilcon A contact lens with ketotifen. etafilcon A contact lens without ketotifen
Period Title: Overall Study
Started 206 104
Completed 196 101
Not Completed 10 3
Reason Not Completed
Withdrawal by Subject             4             0
Adverse Event             3             0
Lost to Follow-up             1             0
scheduled eye surgery             0             1
did not meet exclusion criteria             1             2
pregnant             1             0
Arm/Group Title K-lens Placebo Total
Hide Arm/Group Description etafilcon A contact lens with ketotifen. etafilcon A contact lens without ketotifen Total of all reporting groups
Overall Number of Baseline Participants 206 104 310
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 206 participants 104 participants 310 participants
31  (11.62) 30  (10.75) 31  (11.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 206 participants 104 participants 310 participants
Female
144
  69.9%
80
  76.9%
224
  72.3%
Male
62
  30.1%
24
  23.1%
86
  27.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 206 participants 104 participants 310 participants
206 104 310
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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.053) 0  (0.129)
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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 104
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 208
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 redness of conjunctiva using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe.
Time Frame baseline and 12 weeks
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.632) -0.1  (0.522)
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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 177
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.105) 0  (0.166)
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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
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.
Time Frame baseline and 12 weeks
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0) 0  (0.106)
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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis includes subjects that completed the 12 week visit per protocol.
Arm/Group Title K-lens Placebo
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.181) -0.1  (0.254)
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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
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 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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.1  (0.28) 0  (0.35)
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 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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.271) 0  (0.256)
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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.515) 0  (0.53)
14.Primary Outcome
Title Corneal Staining - Superior, Change From Baseline
Hide Description 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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.229) 0  (0.149)
15.Primary Outcome
Title Corneal Staining - Central, Change From Baseline
Hide Description 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
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.234) 0  (0.212)
16.Primary Outcome
Title Intraocular Pressure, Change From Baseline
Hide Description [Not Specified]
Time Frame baseline and 12 weeks
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
Mean (Standard Deviation)
Unit of Measure: mm of mercury
-0.3  (2.7) -0.4  (2.707)
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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects/4 eyes.
Arm/Group Title K-lens Placebo
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 179 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
358 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.1  (0.371) 0  (0.235)
18.Primary Outcome
Title Dilated Ophthalmoscopy - Vitreous, Change From Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects / 4 eyes.
Arm/Group Title K-lens Placebo
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 179 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
358 178
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0  (0.149) 0  (0.149)
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 12 weeks
Hide 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
Hide Arm/Group Description:
etafilcon A contact lens with ketotifen.
etafilcon A contact lens without ketotifen
Overall Number of Participants Analyzed 181 89
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
362 178
Measure Type: Number
Unit of Measure: Eyes
362 178
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title K-lens Placebo
Hide Arm/Group Description etafilcon A contact lens with ketotifen. etafilcon A contact lens without ketotifen
All-Cause Mortality
K-lens Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
K-lens Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/206 (0.97%)      0/104 (0.00%)    
Gastrointestinal disorders     
abdominal discomfort requiring hospitalization * [1]  1/206 (0.49%)  1 0/104 (0.00%)  0
Injury, poisoning and procedural complications     
nasal fracture * [2]  1/206 (0.49%)  1 0/104 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
unrelated to test article
[2]
nasal fracture resulting from an accident, unrelated to test article
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
K-lens Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/206 (5.34%)      4/104 (3.85%)    
Infections and infestations     
nasopharyngitis *  11/206 (5.34%)  4/104 (3.85%) 
*
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.
The PI may not publish or publicly present the data and or results of the study without prior approval from Vistakon.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brian Pall OD MS FAAO
Organization: Vistakon
Phone: 904-443-1290
Layout table for additonal information
Responsible Party: Vistakon Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00569777    
Other Study ID Numbers: 07-003-002
First Submitted: November 27, 2007
First Posted: December 7, 2007
Results First Submitted: October 4, 2010
Results First Posted: November 23, 2010
Last Update Posted: March 6, 2015