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OpenTrials
Completed

NCT Number: NCT00833235

A Natural History Study of Patients With Dry Eye

This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jones Eye Institute, Little Rock, Arkansas, 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

  • Males at least 55 years old or females, at least 40 years old with perimenopausal symptoms
  • Baseline OSDI score of ≥ 13
  • Patients with mild to moderate dry eye (dry eye disease patients only; not applicable for control group)

Exclusion criteria

  • Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline
  • History of herpes keratitis or varicella zoster keratitis
  • Any history of allergic conjunctivitis
  • Temporary or permanent occlusion or cauterization of the lacrimal puncta for either eye
  • Any anterior segment surgery involving a limbal or corneal incision (cataract surgery), keratorefractive procedure (LASIK, LASEK, PRK) within 12 months of baseline, or expectation of such surgery within 2 years
  • Patients with known systemic disease
  • Any history of corneal transplant

Treatment and study plan

Artificial tears

Other

Artificial tears (any brand) may be used to treat dry eye symptoms.

Primary outcomes

  1. Percentage of Patients with Progression of Dry Eye Disease

    Time frame: Baseline, 60 Months

Secondary outcomes

  1. Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score

    Time frame: Baseline, 60 Months

  2. Percentage of Patients with an Increase in Blurred Vision

    Time frame: Baseline, 60 Months

  3. Change from Baseline in Schirmer's Test

    Time frame: Baseline, 60 Months

  4. Change from Baseline in Conjunctival Staining Score on a 6-Point Scale

    Time frame: Baseline, 60 Months

  5. Change from Baseline in Corneal Staining Score on a 6-Point Scale

    Time frame: Baseline, 60 Months

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2009
Registry last updated
Jul 25, 2017

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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