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Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease (DED)

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: NCT03785340
Recruitment Status : Completed
First Posted : December 24, 2018
Results First Posted : June 6, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
Ocugen

Brief Summary:
This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half will receive ophthalmic buffered saline (placebo).

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Brimonidine Tartrate Drug: Placebos Phase 3

Detailed Description:

Dry eye disease (DED) is a common ocular disorder involving the aberrant production and instability of tear film, which results in damage to the ocular surface and is correlated with symptoms of ocular discomfort.

This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study in the United States conducted at approximately 25 centers. Upon meeting the eligibility criteria, enrolled subjects will be randomly assigned in a 1:1 (test:control) fashion to receive either Brimonidine Nanoemulsion Eye Drops 0.20% investigational product (test) or ophthalmic buffered saline (placebo).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Placebo-Controlled, Double-Masked, Multicenter, Safety and Efficacy Study of Brimonidine Tartrate 0.2% Nanoemulsion Eye Drops in Patients With Dry Eye Disease (DED)
Actual Study Start Date : December 3, 2018
Actual Primary Completion Date : February 25, 2019
Actual Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: OCU-310
Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks
Drug: Brimonidine Tartrate
Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.
Other Name: OCU-310

Placebo Comparator: Placebos
Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks
Drug: Placebos
Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.
Other Name: Ophthalmic buffered saline solution




Primary Outcome Measures :
  1. Change From Baseline to 4 Weeks (Day 28) in Symptom Assessment in Dry Eye (SANDE) Questionnaire Score [ Time Frame: Baseline, 4 weeks (Day 28) ]
    The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

  2. Change From Baseline to 4 Weeks (Day 28) in Lissamine Green Conjunctival Staining Scores [ Time Frame: Baseline, 4 Weeks (Day 28) ]
    Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.


Secondary Outcome Measures :
  1. Change From Baseline to 2 Weeks (Day 14) in SANDE Score [ Time Frame: Baseline, 2 weeks (Day 14) ]
    The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.

  2. Change From Baseline to 2 Weeks (Day 14) in Lissamine Green Conjunctival Staining Scores [ Time Frame: Baseline, 2 Weeks (Day 14) ]
    Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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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:

  1. Aged 18 years or older.
  2. Sign and date informed consent form approved by the IRB
  3. History of Dry Eye Disease for ≥6 months
  4. Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1):

    1. Conjunctival staining at ≥3 (out of a possible score of 6 per eye), and
    2. Schirmer test (with anesthesia) at ≥1 to ≤7mm in 5 minutes
  5. Symptomatic evidence of DED by having a global symptom score (Overall SANDE) ≥40 mm at Screening and Baseline (Day 1) visit
  6. Intraocular pressure (IOP) ≥ 5 mmHg and ≤22 mmHg in each eye
  7. Women who satisfy one of the following:

8a. Are of child-bearing potential (WOCP) who are not pregnant or lactating and who are either abstinent or sexually active on an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study (i.e., until Day 28), OR 8b. Are post-menopausal or have undergone a sterilization procedure

Exclusion Criteria:

  1. Allergic to brimonidine or any similar products, or excipients of brimonidine
  2. Use of contact lenses within 14 days prior to Screening visit or planned use during study
  3. Currently receiving brimonidine or other treatment for glaucoma or ocular hypertension or history of glaucoma surgery.
  4. Receiving or have received any experimental or investigational drug or device within 30 days prior to Screening visit
  5. Intraocular pressure <5 mmHg or >22 mmHg in either eye
  6. Active ocular infection or history of ocular herpetic keratitis
  7. History of neurotrophic keratitis or ocular neuropathic pain
  8. Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months
  9. Punctal occlusion within 3 months prior to Screening visit or during study
  10. Corneal epithelial defect larger than 1 mm2 in either eye
  11. Have active drug/alcohol dependence or abuse history
  12. Are neonates, pregnant/lactating women, children, or others who may be considered vulnerable populations
  13. Received corticosteroid-containing eye drops within 14 days prior to Screening visit or planned use during study
  14. Any change in systemic corticosteroids/immunosuppressives, cyclosporine ophthalmic emulsion 0.05% (Restasis®), cyclosporine ophthalmic solution 0.09% (Cequa™), or lifitegrast ophthalmic solution 5% (Xiidra®) within 30 days prior to Screening visit or planned change during study
  15. In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
  16. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol

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): NCT03785340


Locations
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United States, California
Aesthetic Eye Care Institute/David Wirta, MD and Associates
Newport Beach, California, United States, 92663
Martel Medical Eye Group
Rancho Cordova, California, United States, 95670
United States, Florida
Rand Eye Institute
Pompano Beach, Florida, United States, 33064
United States, Illinois
Chicago Cornea Consultants
Hoffman Estates, Illinois, United States, 60169
United States, Kansas
Heart of America Eye Care, P. A.
Mission, Kansas, United States, 66204
United States, Missouri
Ophthalmology Associates
Saint Louis, Missouri, United States, 63131
United States, Ohio
Apex Eye- Kenwood
Cincinnati, Ohio, United States, 45236
Apex Eye-Montgomery
Cincinnati, Ohio, United States, 45242
Abrams Eye Center
Cleveland, Ohio, United States, 44115
United States, Pennsylvania
Scott and Christie Eyecare Associates
Cranberry Township, Pennsylvania, United States, 16066
United States, Tennessee
Total Eye Care
Memphis, Tennessee, United States, 38119
Toyos Clinic
Nashville, Tennessee, United States, 37215
United States, Texas
Midtown Eye Physicans & Associates
Houston, Texas, United States, 77004
Advanced Laser Vision & Surgical Institute
Houston, Texas, United States, 77034
Revolution Research, Inc; Lake Travis Eye and Laser Center
Lakeway, Texas, United States, 78734
United States, Utah
The Eye Institute of Utah
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Ocugen
  Study Documents (Full-Text)

Documents provided by Ocugen:
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Responsible Party: Ocugen
ClinicalTrials.gov Identifier: NCT03785340    
Other Study ID Numbers: OCU-310-301
First Posted: December 24, 2018    Key Record Dates
Results First Posted: June 6, 2022
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ocugen:
Dry Eye Disease
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Brimonidine Tartrate
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs