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OpenTrials
Completed

NCT Number: NCT00569777

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

The purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gardena, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • active ocular infection
  • history of ocular surgery
  • use of topical ophthalmic preparations (including rewetting drops)
  • pregnancy or lactation

Treatment and study plan

K-Lens (generic name not established) and Ketotifen

Device

combination drug-device product: contact lens (device) and anti-allergy drug

Placebo Lens

Device

contact lens without drug

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. Intraocular Pressure, Change From Baseline

    Time frame: baseline and 12 weeks

  17. 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.

  18. 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.

  19. 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.

Sponsors and collaborators

Lead sponsor

Vistakon Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 7, 2007
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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