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Completed

NCT Number: NCT01459588

Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease

This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Petaluma, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Dry eyes
  • Current use of eye drops for dry eye at least twice daily, on average for at least 3 months

Exclusion criteria

  • Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
  • Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
  • Active ocular allergy

Treatment and study plan

Carboxymethylcellulose Based Eye Drop Formulation A

Drug

Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.

Other names: Refresh Optive® Advanced Sensitive Eye Drops

Carboxymethylcellulose Based Eye Drop Formulation B

Drug

Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Other names: Refresh Optive® Advanced Eye Drops

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops

Drug

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Other names: Optive® Sensitive Preservative-Free Lubricant Eye Drops

Carboxymethylcellulose Based Lubricant Eye Drops

Drug

Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.

Other names: Optive® Lubricant Eye Drops

Primary outcomes

  1. Change From Baseline in Ocular Surface Disease Index© Questionnaire Score

    Time frame: Baseline, Day 30

    The Ocular Surface Disease Index© Questionnaire is a 12-item survey assessing the overall severity of dry eye disease per patient. Each question is rated on a 5-point scale ranging from 0=none of the time to 4=all of the time for a total possible score of 0=No disease to 100=Maximum severity of disease. A negative change from baseline indicates improvement.

Secondary outcomes

  1. Change From Baseline in Tear Break-up Time

    Time frame: Baseline, Day 30

    Tear Break-up Time (TBUT) was assessed at Baseline and Day 30. TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The shorter the tear break-up time, the worse the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive change from baseline indicates improvement.

  2. Change From Baseline in Corneal Staining

    Time frame: Baseline, Day 30

    The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0= no staining, 5 = severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in corneal staining (improvement).

  3. Change From Baseline in Conjunctival Staining

    Time frame: Baseline, Day 30

    The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. The worse eye at baseline is used to calculate the change at Day 30. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).

  4. Change From Baseline in Schirmer Test Results

    Time frame: Baseline, Day 30

    The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. The worse eye at baseline is used to calculate the change at Day 30. A positive number change from baseline indicates an increase in tears (improvement).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2011
Registry last updated
Apr 16, 2019

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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