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Completed

NCT Number: NCT03688802

Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation

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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tufts

Boston, Massachusetts, 02111, United States

About this study

This was a Phase 2, single-center, randomized, masked (including all subjects, investigators, and study site personnel), placebo-controlled study designed to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in stimulating goblet cell and Meibomian gland function in in adult subjects with DED. Approximately 45 subjects at least 18 years of age with a physicians' diagnosis of DED and meeting all other study eligibility criteria were planned to be randomized to receive a single application of 0.2% (1.2 mg/mL) OC-01 or placebo

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OC-01 (varenicline) nasal spray

Drug

OC-01 (varenicline) nasal spray

Placebo (vehicle control) nasal spray

Drug

Placebo

Primary outcomes

  1. Mean Change in Goblet Cell Area

    Time frame: Baseline (pre-treatment), 1 day (post treatment)

    Mean change in Goblet Cell Area with a larger decrease is indicative of a better outcome.

  2. Mean Change in Goblet Cell Perimeter

    Time frame: Baseline (pre-treatment), 1 day (post treatment)

    Mean change in Goblet Cell Perimeter. A larger decrease is indicative of a better outcome.

  3. Change in Meibomian Gland Area, Upper Lid

    Time frame: Baseline (pre-treatment), 1 day (post treatment)

    Change in Meibomian gland area, upper lid. A larger decrease is indicative of a better outcome

  4. Mean Change in Meibomian Gland Area, Lower Lid.

    Time frame: Baseline (pre-treatment), 1 day (post treatment)

    Mean change in Meibomian Gland Area, lower Lid. A larger decrease is indicative of a better outcome.

  5. Mean Change in Meibomian Gland Perimeter, Upper Lid.

    Time frame: Baseline (pre-treatment), 1 day (post treatment)

    Chane in Meibomian Gland Perimeter, upper lid. A larger decrease is indicative of a better outcome.

  6. Mean Change in Meibomian Gland Perimeter, Lower Lid

    Time frame: Baseline (pre-treatment), 1 day (post treatment)

    Mean change in Meibomian Gland Perimeter, lower lid. A larger decrease is indicative of a better outcome.

Sponsors and collaborators

Lead sponsor

Oyster Point Pharma, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 28, 2018
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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