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Dry Eye Disease Study With Brimonidine

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ClinicalTrials.gov Identifier: NCT03418727
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ocugen

Brief Summary:
To evaluate the tolerability and preliminary efficacy of Brimonidine eye drops (with and without corticosteroid eye drops) for the treatment of Dry Eye Disease (DED).

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Brimonidine Drug: Brimonidine Mono Therapy Drug: sodium carboxymethylcellulose Drug: Corticosteroid Eye Drop Phase 2

Detailed Description:
Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, Day 84, and Day 105. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Proof-of-Concept Study of Brimonidine Eye Drops for the Treatment of Dry Eye Disease (DED)
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Study Drug Arm #1
Combination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks
Drug: Brimonidine
Two products delivered in sequence twice daily.
Drug: Corticosteroid Eye Drop
Eye drop to be administered after Briomonidine in treatment arm 1
Experimental: Study Drug Arm #2
Monotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks
Drug: Brimonidine Mono Therapy
Brimonidine given twice daily along with placebo drops
Placebo Comparator: Control Arm
Placebo: sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application, two time a day (BID) for 12 weeks
Drug: sodium carboxymethylcellulose
Placebo given twice daily.



Primary Outcome Measures :
  1. Main Objective (Tolerability) [ Time Frame: Baseline - Day 84 ]
    Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analogue Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, and Day 84,. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  4. Objective evidence of DED in at least one eye by having 2 or more of the following 4 signs in the same eye at Screening and Baseline (Day 1) visits:

    i. Conjunctival staining at >/= 1 (out of a possible score of 6 per eye) ii. Corneal staining at >/= 2 (out of a possible score of 15 per eye) iii. Noninvasive Tear Break-Up Time (NITBUT) at </= 7 seconds iv. Schirmer test at <10mm in 5 minutes

  5. Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both Screening and Baseline (Day 1) visits
  6. Intraocular pressure (IOP) >/= 5 mmHg and </= 22 mmHg in each eye
  7. Women who satisfy one of the following:

    1. 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, OR
    2. Are post-menopausal or have undergone a sterilization procedure

Exclusion Criteria:

  1. Allergic to brimonidine, corticosteroids or any similar products, or excipients of brimonidine including benzalkonium chloride (BAK)
  2. Use of contact lenses
  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, institutionalized individuals, or others who may be considered vulnerable populations
  13. Received corticosteroid-containing eye drops within the past 7 days or systemic corticosteroids/immunosuppressives within the past 3 months
  14. Received cyclosporine ophthalmic emulsion 0.05% (Restasis®) or lifitegrast ophthalmic solution 5% (Xiidra™) within 30 days prior to Screening visit
  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): NCT03418727


Contacts
Contact: Kevin Berth 4842373398 kevin.berth@ocugen.com

Locations
United States, Illinois
Chicago Cornea Consultants Completed
Hoffman Estates, Illinois, United States, 60169
Brenart Eye Clinic Recruiting
Yorkville, Illinois, United States, 60560
Contact: Mary Melick    630-553-6166    marym@brenarteye.com   
Principal Investigator: Nicole Zangler, DO         
United States, Utah
The Eye Institute of Utah Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Natalie Forcht    801-263-5745    nforcht@theeyeinstitue.com   
Contact: Laurie Adams    801-263-5745    ladams@theeyeinstitute.com   
Principal Investigator: Randy Carter, DO         
Sponsors and Collaborators
Ocugen
Investigators
Study Director: Kevin Berth Ocugen

Responsible Party: Ocugen
ClinicalTrials.gov Identifier: NCT03418727     History of Changes
Other Study ID Numbers: OCU-310-DED-2017
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Conjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Tetrahydrozoline
Brimonidine Tartrate
Carboxymethylcellulose Sodium
Pharmaceutical Solutions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Laxatives
Gastrointestinal Agents