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Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation (The IMPERIAL Study)

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ClinicalTrials.gov Identifier: NCT03688802
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Oyster Point Pharma, Inc.

Brief Summary:
The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray as compared to placebo in simulating Goblet Cell and Meibomian Gland function in adult subjects with DED.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: OC-01 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Randomized, Controlled, Masked Clinical Trial to Evaluate the Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation (The IMPERIAL Study)
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Active Comparator: OC-01 Drug: OC-01
OC-01

Placebo Comparator: Placebo Drug: Placebo
Placebo




Primary Outcome Measures :
  1. mean change in goblet cell area from Pre-Treatment to Post-Treatment [ Time Frame: 1 Day ]
  2. mean change in meibomian gland area from Pre-Treatment to Post-Treatment [ Time Frame: 1 Day ]
  3. mean change in goblet cell perimeter from Pre-Treatment to Post-Treatment [ Time Frame: 1 Day ]


Information from the National Library of Medicine

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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:

  • Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to visit 1.

Exclusion Criteria:

  • Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser-assisted in-situ keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of Visit 1
  • Have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the Investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with DED are allowed.
  • Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.)
  • Have a known hypersensitivity to any of the procedural agents or study drug components
  • Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject

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): NCT03688802


Contacts
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Contact: Kristen Striffler 609 382-9034 ext 6038 kstriffler@oysterpointrx.com

Locations
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United States, Massachusetts
Tufts Recruiting
Boston, Massachusetts, United States, 02111
Contact: Kristen Striffler         
Principal Investigator: Pedram Hamrah, MD         
Sponsors and Collaborators
Oyster Point Pharma, Inc.

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Responsible Party: Oyster Point Pharma, Inc.
ClinicalTrials.gov Identifier: NCT03688802     History of Changes
Other Study ID Numbers: OPP-005
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Eye Diseases