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Trial record 59 of 8749 for:    Eye AND Eye Diseases

A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02553772
Recruitment Status : Completed
First Posted : September 18, 2015
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Carboxymethylcellulose Based Eye Drop Drug: Carboxymethylcellulose Sodium 0.5% Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease
Actual Study Start Date : January 6, 2016
Actual Primary Completion Date : September 9, 2016
Actual Study Completion Date : September 9, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases Tears

Arm Intervention/treatment
Experimental: OM3 Tear
Carboxymethylcellulose based eye drop [Omega-3 (OM3) Tear] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Drug: Carboxymethylcellulose Based Eye Drop
Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Active Comparator: REFRESH OPTIVE® ADVANCED
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Drug: Carboxymethylcellulose Sodium 0.5%
Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
Other Name: REFRESH OPTIVE® ADVANCED




Primary Outcome Measures :
  1. Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score [ Time Frame: Baseline, Day 90 ]
    The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.


Secondary Outcome Measures :
  1. Change From Baseline in Tear Break-up Time (TBUT) [ Time Frame: Baseline, Day 90 ]
    TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. The worse eye is used for the calculations and is defined as the eye with the shortest average TBUT at Baseline. A positive number change from Baseline indicates improvement and a negative number change from Baseline indicates a worsening.

  2. Change From Baseline in Corneal Staining Score [ Time Frame: Baseline, Day 90 ]
    Total corneal staining with fluorescein was measured in the worse eye using a 6-point scale where 0= none, no staining (best) to 5=severe staining (worst). The total score is calculated as the sum of 5 regions of the cornea, resulting in a possible minimum score of 0 and a maximum possible score of 25 (severe staining score of 5 in all 5 regions). The worse eye is defined as the eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

  3. Change From Baseline in Conjunctival Staining Score [ Time Frame: Baseline, Day 90 ]
    Total conjunctival staining with lissamine green was measured in the worse eye using a 6-point scale where 0= none (best), no staining to 5=severe staining (worst). The total score is calculated as the sum of the 6 regions of the conjunctiva, resulting in a minimum possible score of 0 maximum possible score of 30 (severe staining score of 5 in 6 regions). The worse eye is defined as eye with the highest score at Baseline. A negative change from Baseline represents a decrease in staining (improvement).

  4. Change From Baseline in the Schirmer Test [ Time Frame: Baseline, Day 90 ]
    The Schirmer Test measures tears produced by the eye over 5 minutes using a paper strip inserted into the eye. The results indicate the presence of dry eye (Normal = greater than 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 defined as the eye with the lowest score at baseline is used to calculate the change at Day 90. A positive number change from baseline indicates an increase in tears (improvement).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Used artificial tears for dry eye
  • Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria:

  • Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
  • Herpes keratitis in the last 6 months
  • Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553772


Locations
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United States, California
The Private Practice of Milton Hom, OD
Azusa, California, United States, 91702
Havana Research Institute LLC
Burbank, California, United States, 91506
Lugene Eye Institute
Glendale, California, United States, 91204
Eric M. White, OD, INC
San Diego, California, United States, 92123
United States, Missouri
Moyes Eye Center, PC
Kansas City, Missouri, United States, 64154
Ophthalmology Associates
Saint Louis, Missouri, United States, 63131
United States, New York
Rochester Ophthalmological Group, PC
Rochester, New York, United States, 14618
United States, North Carolina
Charlotte Eye Ear Nose
Charlotte, North Carolina, United States, 28210
United States, Pennsylvania
Scott and Christie and Associate
Cranberry Township, Pennsylvania, United States, 16066
United States, Texas
Texan Eye
Austin, Texas, United States, 78731
Australia
Department of Optometry & Vision Sciences, The University of Melbourne
Parkville, Australia, VIC 3010
Prof. M.T. Coroneo Pty. Ltd.
Randwick, Australia, NSW 2031
The University of New South Wales School of Optometry and Vision Science
Sydney, Australia, NSW 2052
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02553772     History of Changes
Other Study ID Numbers: 11182X-001
First Posted: September 18, 2015    Key Record Dates
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Keratoconjunctivitis Sicca
Keratoconjunctivitis
Conjunctivitis
Keratitis
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Laxatives
Gastrointestinal Agents