Trial Outcomes & Findings for Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers (NCT NCT00889252)

NCT ID: NCT00889252

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: 250 participants
• Primary outcome timeframe: baseline and 12 weeks
• Results posted on: 2015-03-06

Participant Flow

Participant milestones

Measure	K-Lens Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens contact lens without drug
Overall Study STARTED	168	82
Overall Study COMPLETED	161	78
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Measure	K-Lens Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens contact lens without drug
Overall Study Adverse Event	2	4
Overall Study Withdrawal by Subject	3	0
Overall Study Protocol Violation	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	K-Lens n=168 Participants Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=82 Participants contact lens without drug	Total n=250 Participants Total of all reporting groups
Age, Continuous	32.6 years STANDARD_DEVIATION 12.48 • n=5 Participants	29.3 years STANDARD_DEVIATION 10.77 • n=7 Participants	31.5 years STANDARD_DEVIATION 12.03 • n=5 Participants
Sex: Female, Male Female	117 Participants n=5 Participants	46 Participants n=7 Participants	163 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	36 Participants n=7 Participants	87 Participants n=5 Participants
Region of Enrollment United States	168 participants n=5 Participants	82 participants n=7 Participants	250 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=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Lid and Lid Margin Erythema, 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 lid swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe

Outcome measures

Measure	K-Lens n=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
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 conjunctival redness using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe

Outcome measures

Measure	K-Lens n=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Conjunctival Redness, Change From Baseline	-0.3 Units on a scale Standard Deviation 0.67	-0.1 Units on a scale Standard Deviation 0.58

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=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Conjunctival Chemosis, 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 swelling using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe

Outcome measures

Measure	K-Lens n=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
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, 4=very severe

Outcome measures

Measure	K-Lens n=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Corneal Erosion, 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 posterior cornea using the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe

Outcome measures

Measure	K-Lens n=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
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=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Lens Pathology, Change From Baseline	0 Units on a scale Standard Deviation 0.23	0 Units on a scale Standard Deviation 0.20

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=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
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=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
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 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

Outcome measures

Measure	K-Lens n=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Corneal Staining - Nasal, Change From Baseline	0 Units on a scale Standard Deviation 0.27	0 Units on a scale Standard Deviation 0.24

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 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=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Corneal Staining - Temporal, Change From Baseline	0 Units on a scale Standard Deviation 0.20	0 Units on a scale Standard Deviation 0.22

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=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=75 Participants contact lens without drug
Corneal Staining - Inferior, Change From Baseline	-0.1 Units on a scale Standard Deviation 0.51	0.0 Units on a scale Standard Deviation 0.43

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 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=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Corneal Staining - Superior, Change From Baseline	0 Units on a scale Standard Deviation 0.13	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 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

Outcome measures

Measure	K-Lens n=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Corneal Staining - Central, Change From Baseline	0 Units on a scale Standard Deviation 0.19	0 Units on a scale Standard Deviation 0.19

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=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Intraocular Pressure - Change From Baseline	0.8 mm of mercury Standard Deviation 2.45	0.6 mm of mercury Standard Deviation 2.51

PRIMARY outcome

Timeframe: baseline and 12 weeks

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

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=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Dilated Ophthalmoscopy - Fundus, 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 in the vitreous (gel-like fulid of the eye), using the scale: 0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe.

Outcome measures

Measure	K-Lens n=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Dilated Ophthalmoscopy - Vitreous, Change From Baseline	0 Units on a scale Standard Deviation 0	0 Units on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: at the 12 week visit

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=316 eyes Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=150 eyes contact lens without drug
Visual Acuity Assessment	316 Eyes	150 Eyes

Adverse Events

K-Lens

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	K-Lens n=168 participants at risk Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=82 participants at risk contact lens without drug
Reproductive system and breast disorders Benign adenoma	0.60% 1/168 • Number of events 1	0.00% 0/82
Gastrointestinal disorders Cholelithiasis	0.60% 1/168 • Number of events 1	0.00% 0/82

Other adverse events

Measure	K-Lens n=168 participants at risk Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug	Placebo Lens n=82 participants at risk contact lens without drug
Eye disorders Instillation Site Irritation	7.1% 12/168	0.00% 0/82

Additional Information

Brian Pall OD MS FAAO

Vistakon

Phone: 904-443-1290

Results disclosure agreements

• Principal investigator is a sponsor employee Investigator agrees not to publish or publicly present the results of the study without the prior written approval of the sponsor.
• Publication restrictions are in place

Restriction type: OTHER