Dry Eye

Navigating the rapidly accelerating field of dry eye research demands a CRO that can lead you ahead of the pack. Companies worldwide partner with Ora’s Dry Eye Experts to reduce risk and take their discoveries to market.

Gritty, scratchy, burning eye or blurred vision is a way of life for 100 million people worldwide suffering with dry eye disease. Even people with normal eye health can experience symptoms of dry eye due to seasonal changes, adverse environmental conditions, and increased demands on visual tasking. Finding therapeutic treatments that can treat both the signs and symptoms of dry eye has become a priority for many compound / drug developers, biopharmaceutical companies and investors.

Preclinical Dry Eye Model

A custom-built chamber, the Murine CAE™ has controlled temperate, low humidity and high airflow to induce dry eye in scopolamine-injected mice.
» Learn More about our Preclinical Services

Indication Preclinical Model
Dry Eye Murine CAESM (Scopolamine/low humidity chamber)

At Ora, we have 20 years of experience evaluating the complex, multifactorial nature of dry eye disease. We know what it takes to successfully develop dry eye programs. We’ve encountered all the challenges inherent in conducting controlled studies and indentified the variables that can erode your ability to measure drug effect. Ora’s clinical expertise, scientific approach, and technologically advanced models are the reason we conduct 95% of all dry eye protocols.

If you’re already committed to a dry eye program, Ora stands ready to assist you with a comprehensive array of consulting and operational services. Our customized, layered approach to dry eye clinical trials can provide you with exactly the services you need to reach your dry eye research objectives.

If you’re in the discovery phase of compound / drug development , Ora can help you explore the options for addressing dry eye disease along every step of drug development pathway.

Talk with George Ousler our Dry Eye Expert.
(978) 685-8900 George Ousler

Ora knows Dry Eye.

Listen to George Ousler talk about Dry Eye’s future in this OIS podcast.

George Ousler

Unparalleled Experience

Ora’s Dry Eye Team has been innovating dry eye research for over 20 years. Led by George Ousler, the Team consists of 20 full-time clinical specialists who have studied more than 10,000 patients across 150 dry eye trials. Our Team’s sole focus is fine-tuning, managing and streamlining dry eye clinical trials. We conduct research and development to continually improve clinical processes, developing new technology and methods to overcome the pitfalls of dry eye clinical trials, from environmental and seasonal factors to the placebo effect. Armed with this expertise, we’re in the trenches supporting investigators and managing every aspect of the clinical trial process, ensuring better trial outcomes and return on investment for our clients.

Therapeutic Approaches:
  • Anti-inflammatories
  • Secretagogues
  • Mucomimetic
  • Hormonal
  • Anti-evaporative
  • Nutritional supplements
  • Polymers / OTC Products

 

Trial Experience:

 

Regulatory Experience:
  • Long standing interactions with the FDA, EMA, PMDA over the past 40 years.
  • Ora has played an instrumental role in 34 NDAs across various therapeutic areas
  • Client representation
  • Regulatory writing pre-IND, IND, NDA preparations and submission

 

Trial Execution

Ora’s approach to clinical trial management is hands-on and results-focused. Unlike other CRO’s, our Dry Eye Team doesn’t run trials from the sidelines. We manage trials on-site, working with investigators and staff to ensure protocol adherence and promptly address and resolve any operational issues. Utilizing OraNet- our base of 30 established sites experienced in dry eye clinical trials, our in-house, active database of 20,000 dry eye subjects, and our process of block enrollment- scheduling all study subjects before the trial start date, we’re able to set and meet the most aggressive study timelines. Our approach to trial execution delivers what you value most - experienced trial management, protocol adherence and speed of execution.

OraNet: Experienced Network of Dry Eye Sites
  • Over 30 established sites experienced in dry eye clinical trials
  • Principal investigators who specialize in Cornea / External disease with experience evaluating dry eye endpoints
  • Extensive investigator training programs for trial consistency
  • Learn more about OraNet »

 

Subject Database: Categorized by disease state; Custom queried for every protocol
  • Over 20,000 subjects in the Ora Dry Eye Database
  • Categorized by severity and disease state – subject population tailored to study protocol
  • Dedicated subject recruitment team for fast screening and enrollment
  • Learn more about Subject Recruiting »

 

Site Management: Dedicated Dry Eye Team
  • Dry Eye Team of 20 full-time specialists focused solely on dry eye research
  • On- site support and management to ensure protocol adherence and enhance the standardization of study visits
  • Operational approach that streamlines and accelerates patient screening and enrollment

 

Scientific Approach

At Ora, our fierce drive to innovate has compelled us to develop advanced technologies to standardize and refine dry eye research and drug development. Our Controlled Adverse Environment (CAEsm), an environmental chamber that exacerbates both the signs and symptoms of dry eye in a controlled, reproducible manner, is used in single and multi-center trials to reduce data variability between sites. Ora’s Ocular Protection Index (OPI) 2.0 System evaluates ocular surface protection under a natural blink pattern and normal visual conditions. Along with our Calibra scales and tear film break up time (TFBUT), these models deliver well controlled studies with precise and predictable endpoints while decreasing study variability, minimizing the placebo effect, and lowering the number of subjects needed for each trial.

Enhanced Environmental Trials:
  • Well controlled
  • Large database of patients = fewer sites = decreased variability.
  • Feet on the Ground - Ora staff works on-site.
  • Accelerated timeline
  • Proprietary Calibra scales / Endpoints (OPI etc.)
  • Trial executed within a single season
  • Learn more about Enhanced Enviro Trials »

 

Controlled Adverse Environmental (CAE) Model:
  • Ora pioneered the CAE℠ Model, Standard in dry eye trials
  • Precise Screening for identifying correct patient populations
  • CAE℠ endpoints = controlled influential factors (humidity, temperature, airflow etc.)
  • Consistent ocular stress test / environmental conditions
  • Various CAE℠ model study designs tailored to investigational therapies MOA
  • Learn more about our Controlled Adverse Environmental (CAE) Model »
Endpoints:

 

Scales: