Non-invasive Ocular Surface Measurements Before and After Interventions

This study has been terminated.
(The study was terminated.)
Sponsor:
Information provided by (Responsible Party):
James V. Aquavella, MD, University of Rochester
ClinicalTrials.gov Identifier:
NCT01228929
First received: October 25, 2010
Last updated: August 13, 2014
Last verified: August 2014

October 25, 2010
August 13, 2014
July 2010
January 2014   (final data collection date for primary outcome measure)
Evaluation of Ocular Surface [ Time Frame: Over the course of multiple years ] [ Designated as safety issue: No ]
Objectively evaluate the ocular surface (pre-corneal tear film) of individuals prior to and after an intervention (such as a dry eye treatment, environmental change, artificial tear use, or contact lens wear) in a controlled-environmental chamber, over time using non-contact instruments.
Evaluation of Ocular Surface [ Time Frame: Over the course of one year ] [ Designated as safety issue: No ]
Objectively evaluate the ocular surface (pre-corneal tear film) of individuals prior to and after an intervention (such as a dry eye treatment, environmental change, artificial tear use, or contact lens wear) in a controlled-environmental chamber, over time using non-contact instruments.
Complete list of historical versions of study NCT01228929 on ClinicalTrials.gov Archive Site
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Non-invasive Ocular Surface Measurements Before and After Interventions
Non-invasive Ocular Surface Measurements Before and After Interventions

Objectively evaluate the ocular surface (pre-corneal tear film) of individuals prior to and after an intervention (such as a dry eye treatment, environmental change, artificial tear use, or contact lens wear) in a controlled-environmental chamber, over time using non-contact instruments.

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Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Dry Eye Syndromes
  • Healthy
  • Contact Lens
  • Other: Patient-directed or physician-recommended interventions.
    These interventions may include obtaining baseline data (prior to the intervention) and data after the intervention that may be performed at one or more visits. The subject's physician may recommend performing a dry eye treatment, such as wearing moisture retaining goggles, performing lid massage, using compresses or scrubs, or taking a nutritional supplement. The subject may decide to begin a homeopathic intervention such as water misting, humidifier use or exposure to an herbal scent. The subject may perform the intervention for a period of time and then come to the research site for measurements or may perform the intervention at the study site so measurements are timed close to the intervention. The study duration is one or two visits in one day each lasting about one hour. Depending on the intervention a second visit may be requested on the same day, for example, to determine if the effects of lid massage are effective for 6-8 hours.
  • Other: Environmental Chamber Condition Change Intervention
    For condition change studies, the chamber will operate between 65 and 85 degrees F and 25% and 80% RH with air flow turned off or set to a maximum of 3-4 m/s. For this type of study, we will have the subject acclimate to a set of environmental conditions (approximately 20-30 minutes) and take a set of measurements. Then we will change the conditions (rate of change is 3 degrees F/hour and 3% RH/hour), have the subject acclimate to these conditions (later on the same day or on another day) and take another set of measurements. The expected study length is approximately two hours for a single visit. Subjects may be asked to return for additional visits to accommodate a variety of chamber conditions (temp, humidity, airflow) within the prescribed limits above.
  • Drug: Eye Drop Intervention
    This type of intervention will require a screening exam to confirm the subject's eye condition and suitability for study. These studies use FDA-approved over-the-counter eye drops, artificial tears or saline (dilute solution of salt water) used as indicated by the FDA. Dispensing will use a new single use container or separate bottle for each subject. We will instill one drop in the eye. The study length is one visit lasting a maximum of two hours.
  • Other: Contact Lens Intervention
    A screening exam is required to confirm the subject's eye condition and suitability for study. We will have experienced lens wearers wear their own lenses or wear the same type of lenses (soft or rigid gas permeable [RGP]) within the FDA approved modality (daily, continuous or extended wear) and replacement cycle (for example, daily, one week, one month, etc.) as described in the lens package insert and/or prescribed by their eye care provider. We will take measurements of the subject without the lenses, have the subject insert the lenses, wait about five minutes for the eye to settle down, then take another set of measurements. The subject will then leave the site and return for a second visit at 6-8 hours of wear for an additional measurement and a final measurement five minutes after removal of the contact lenses. Each visit may take a maximum of one hour. If the subject did not wear his/her own pair of contact lenses, the subject will return the lenses.
  • Other: Non-Interventional
    We are interested in obtaining information about your current eye status with no or only a slight behavioral change. For example, we may ask you to blink in a certain way, such as with your normal blink rate, or with a more or less frequent blink than your normal rate. Or we may ask you to perform an everyday task, such as reading a book or watching a monitor. These tasks are considered non-invasive as they are tasks individuals might perform during the day to relieve dry eye symptoms.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
261
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals with dry eye diagnoses (aqueous deficient dry eye [ADDE], and/or evaporative dry eye), dry eye symptoms (as associated with Sjogren's Syndrome diagnosis), refractive surgery, contact lens use, and exposure to dry work environments are appropriate to correlate clinical tests, subjective responses and objective measurements of current ocular surface status and to study clinically-recommended or patient-directed dry eye treatments such as taking dietary supplements, wearing moisture-retaining goggles, performing lid massage, or using over the counter eye drops or artificial tears.
  • Individuals who do not currently have dry eye symptoms but who may be at risk for dry eye diagnosis, and those who have dry eye symptoms but no clinical dry eye diagnosis, are of interest to correlate clinical tests, subjective responses and objective measurements of current ocular surface status and, if symptoms appear or worsen, to correlate the data with the effect of environmental condition changes, such as increasing the humidity or reducing air flow, on the ocular surface.
  • Individuals who have undergone ocular surgery are at increased risk for dry eye. While some subjects who have had ocular surgery may never develop dry eye symptoms because they have an adequate reserve of tear production, others may develop symptoms as a result of the disruption of the ocular surface, including the anatomy and nerves. Subjects who have had surgery or procedures and are no longer being provided with direct post-operative care may participate in the study. Routine follow-up post- operative care does not disqualify subjects from participation. Subjects who are receiving post-operative care must obtain approval of their clinician to participate in the study.
  • Individuals who have eye conditions that affect the shape or condition of the cornea, such as individuals with keratoconus.
  • Experienced contact lens wearers are appropriate for studies that use their own lenses (soft, rigid gas permeable [RGP], hard [PMMA]) or the same type of lens within the FDA approved modality (daily, continuous or extended wear) and replacement cycle (for example, daily, one week, one month, etc.) as described in the lens package insert and/or prescribed by their eye care provider to investigate ocular surface data before, during and after lens use.
  • Normal individuals, those without a dry eye diagnosis, without dry eye symptoms or those who do not wear contacts to act as controls for the focus areas in the studies.

Exclusion Criteria:

Individuals with eye or medical condition(s) that contraindicate performing screening or measurements will not be eligible for this study. Specific examples include:

  • Individuals will not be dilated if an exam and/or medical history indicted they have a narrow anterior chamber angle, glaucoma, or other contraindications to dilation (like arterio-sclerotic cerebrovascular disease).
  • Individuals with the following will not participate in contact lens studies: presence of ocular or systemic allergies or disease (infection), clinically significant (grade 3 or 4) corneal edema, corneal vascularization, or any other abnormalities of the cornea, tarsal abnormalities or bulbar injection or use of medication that might interfere with contact lens wear.
  • Individuals will not participate in any aspect of the study if: they are pregnant or become pregnant or are lactating, have an infectious disease (e.g. hepatitis, tuberculosis) or have an immuno-suppressive disease (e.g. HIV).
  • Individuals with known sensitivity to dyes or to numbing drops will not be screened using these agents.
  • Individuals who wear dental braces cannot be involved in the measurements in which a dental impression/bite bar is required. The impression material will stick to the braces. Individuals with very sensitive teeth or loose dentures may have difficulty making the dental impression.
Both
18 Years to 89 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01228929
32315
No
James V. Aquavella, MD, University of Rochester
University of Rochester
Not Provided
Principal Investigator: James V Aquavella, MD University of Rochester
University of Rochester
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP