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Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01294384
First received: February 10, 2011
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.


Condition Intervention Phase
Dry Eye Syndromes
Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 1
Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 2
Drug: carboxymethylcellulose sodium based Eye Drops
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Ocular Surface Disease Index© (OSDI) Score [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.


Secondary Outcome Measures:
  • Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    The participant rated the severity of their dry eye symptom: dryness using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms.

  • Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast) [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    Near Visual Acuity was determined using the number of letters read correctly on a low contrast eye chart (gray letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.

  • Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast) [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    Near Visual Acuity was determined using the number of letters read correctly on a high contrast eye chart (black letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.

  • Change From Baseline in Tear Break-Up Time (TBUT) [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    TBUT is defined as the time (seconds) required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from Baseline indicated improvement.

  • Change From Baseline in Corneal Staining [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    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 where 0=no staining to 5=severe staining over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represented a decrease in corneal staining (improvement).

  • Change From Baseline in Conjunctival Staining [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    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 where 0=no staining to 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. A negative number change from baseline represented a decrease in the severity of conjunctival staining (improvement).

  • Change From Baseline in Schirmer Test [ Time Frame: Baseline, Day 90 ] [ Designated as safety issue: No ]
    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 where Normal=greater than or equal to 10 millimeters (mm) of tears and Dry Eye=less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicated an increase in tears (improvement).


Enrollment: 305
Study Start Date: May 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: New Eye Drop Formulation 1
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 1
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
Experimental: New Eye Drop Formulation 2
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 2
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
Active Comparator: Refresh Tears®
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Drug: carboxymethylcellulose sodium based Eye Drops
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
Other Name: Refresh Tears®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current use of an artificial tear product at least twice daily for at least 3 months, on average
  • Ability/agreement to continue wearing existing spectacle correction (glasses) during study

Exclusion Criteria:

  • Anticipated contact lens wear during study or contact lens use within 6 months
  • Active ocular infection or allergy
  • Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
  • Use of any topical cyclosporine products within 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294384

Locations
Australia, New South Wales
Randwick, New South Wales, Australia
Canada, Newfoundland and Labrador
St. John's, Newfoundland and Labrador, Canada
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01294384     History of Changes
Other Study ID Numbers: 10078X-001
Study First Received: February 10, 2011
Results First Received: September 24, 2013
Last Updated: September 24, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Carboxymethylcellulose Sodium
Ophthalmic Solutions
Tetrahydrozoline
Autonomic Agents
Cardiovascular Agents
Gastrointestinal Agents
Laxatives
Nasal Decongestants
Peripheral Nervous System Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 20, 2014