Trial Outcomes & Findings for Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers (NCT NCT00569777)

NCT ID: NCT00569777

Last Updated: 2015-03-06

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 310 participants
• Primary outcome timeframe: baseline and 12 weeks
• Results posted on: 2015-03-06

Participant Flow

Participant milestones

Measure	K-lens etafilcon A contact lens with ketotifen.	Placebo etafilcon A contact lens without ketotifen
Overall Study STARTED	206	104
Overall Study COMPLETED	196	101
Overall Study NOT COMPLETED	10	3

Reasons for withdrawal

Measure	K-lens etafilcon A contact lens with ketotifen.	Placebo etafilcon A contact lens without ketotifen
Overall Study Withdrawal by Subject	4	0
Overall Study Adverse Event	3	0
Overall Study Lost to Follow-up	1	0
Overall Study scheduled eye surgery	0	1
Overall Study did not meet exclusion criteria	1	2
Overall Study pregnant	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	K-lens n=206 Participants etafilcon A contact lens with ketotifen.	Placebo n=104 Participants etafilcon A contact lens without ketotifen	Total n=310 Participants Total of all reporting groups
Age, Continuous	31 years STANDARD_DEVIATION 11.62 • n=5 Participants	30 years STANDARD_DEVIATION 10.75 • n=7 Participants	31 years STANDARD_DEVIATION 11.33 • n=5 Participants
Sex: Female, Male Female	144 Participants n=5 Participants	80 Participants n=7 Participants	224 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	24 Participants n=7 Participants	86 Participants n=5 Participants
Region of Enrollment United States	206 participants n=5 Participants	104 participants n=7 Participants	310 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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

Outcome measures

Measure	K-lens n=181 Participants etafilcon A contact lens with ketotifen.	Placebo n=89 Participants etafilcon A contact lens without ketotifen
Lid and Lid Margin Erythema, Change From Baseline	0 Units on a scale Standard Deviation 0.053	0 Units on a scale Standard Deviation 0.129

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=208 eyes etafilcon A contact lens without ketotifen
Lid and Lid Margin Swelling, Change From Baseline	0 Units on a scale Standard Deviation 0	0 Units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Conjunctival Redness, Change From Baseline	0 Units on a scale Standard Deviation 0.632	-0.1 Units on a scale Standard Deviation 0.522

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=177 eyes etafilcon A contact lens without ketotifen
Conjunctival Chemosis, Change From Baseline	0 Units on a scale Standard Deviation 0.105	0 Units on a scale Standard Deviation 0.166

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Corneal Edema, Change From Baseline	0 Units on a scale Standard Deviation 0	0 Units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Corneal Erosion, Change From Baseline	0 Units on a scale Standard Deviation 0	0 Units on a scale Standard Deviation 0.106

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Analysis includes subjects that completed the 12 week visit per protocol.

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

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Corneal Endothelial, Change From Baseline	0 Units on a scale Standard Deviation 0	0 Units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Lens Pathology, Change From Baseline	0 Units on a scale Standard Deviation 0.181	-0.1 Units on a scale Standard Deviation 0.254

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Flare in Anterior Chamber, Change From Baseline	0 Units on a scale Standard Deviation 0	0 Units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Cells in Anterior Chamber, Change From Baseline	0 Units on a scale Standard Deviation 0	0 Units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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.

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Corneal Staining - Nasal, Change From Baseline	-0.1 Units on a scale Standard Deviation 0.28	0 Units on a scale Standard Deviation 0.35

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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.

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Corneal Staining - Temporal, Change From Baseline	0 Units on a scale Standard Deviation 0.271	0 Units on a scale Standard Deviation 0.256

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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.

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Corneal Staining - Inferior, Change From Baseline	0 Units on a scale Standard Deviation 0.515	0 Units on a scale Standard Deviation 0.53

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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.

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Corneal Staining - Superior, Change From Baseline	0 Units on a scale Standard Deviation 0.229	0 Units on a scale Standard Deviation 0.149

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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.

Outcome measures

Measure	K-lens n=181 Participants etafilcon A contact lens with ketotifen.	Placebo n=89 Participants etafilcon A contact lens without ketotifen
Corneal Staining - Central, Change From Baseline	0 Units on a scale Standard Deviation 0.234	0 Units on a scale Standard Deviation 0.212

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Intraocular Pressure, Change From Baseline	-0.3 mm of mercury Standard Deviation 2.7	-0.4 mm of mercury Standard Deviation 2.707

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects/4 eyes.

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.

Outcome measures

Measure	K-lens n=358 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Dilated Ophthalmoscopy - Fundus, Change From Baseline	-0.1 Units on a scale Standard Deviation 0.371	0 Units on a scale Standard Deviation 0.235

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis. K-lens: missing data for 2 subjects / 4 eyes.

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.

Outcome measures

Measure	K-lens n=358 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Dilated Ophthalmoscopy - Vitreous, Change From Baseline	0 Units on a scale Standard Deviation 0.149	0 Units on a scale Standard Deviation 0.149

PRIMARY outcome

Timeframe: at 12 weeks

Population: Subjects that completed the study per protocol were included in this analysis.

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.

Outcome measures

Measure	K-lens n=362 eyes etafilcon A contact lens with ketotifen.	Placebo n=178 eyes etafilcon A contact lens without ketotifen
Visual Acuity Assessment	362 Eyes	178 Eyes

Adverse Events

K-lens

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	K-lens n=206 participants at risk etafilcon A contact lens with ketotifen.	Placebo n=104 participants at risk etafilcon A contact lens without ketotifen
Injury, poisoning and procedural complications nasal fracture	0.49% 1/206 • Number of events 1	0.00% 0/104
Gastrointestinal disorders abdominal discomfort requiring hospitalization	0.49% 1/206 • Number of events 1	0.00% 0/104

Other adverse events

Measure	K-lens n=206 participants at risk etafilcon A contact lens with ketotifen.	Placebo n=104 participants at risk etafilcon A contact lens without ketotifen
Infections and infestations nasopharyngitis	5.3% 11/206	3.8% 4/104

Additional Information

Brian Pall OD MS FAAO

Vistakon

Phone: 904-443-1290

Results disclosure agreements

• Principal investigator is a sponsor employee The PI may not publish or publicly present the data and or results of the study without prior approval from Vistakon.
• Publication restrictions are in place

Restriction type: OTHER