Trial · NCT03660475
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Ocular Surface Disease Index | Day 29 | The OSDI is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. It is a scale of 0-4 for each of the 12 questions. A minimum value would be "0" and a maximum value would be "48". The higher the value the worse the outcome. |
| Secondary | Lissamine Green Staining | Day 29 | Lissamine green staining; regions: inferior, superior, central, corneal sum, temporal, nasal, conjunctival sum, total eye will be measured using an ocular discomfort score on a scale of 0 (no staining) to 4 (confluent staining). The total eye score is presented. A minimum score would be "0" and a maximal score would be "8". The higher the value the worse the outcome. |
| Secondary | Tear Film Break-up Time | Day 29 | Tear film break-up time is the time taken for the first dry spot to appear on the cornea after a complete blink. |
| Secondary | Conjunctival Redness | Day 29 | Conjunctival redness will be assessed and conjunctival pain will be assessed using a visual analog scale ranging from "0" (none: normal without vasodilation) to "5" (severe: broad ciliary and prominent, horizontal conjunctival vasodilation). A minimal score would be "0" and a maximal score would be "10". The higher the value the worse the outcome . |
| Secondary | Schirmer's Test | Day 29 | Schirmer's Test (without anesthesia) ) involves placing a Schirmer test strip in the lower temporal lid margin of each eye such that the strip fits tightly. Subjects will be instructed to close their eyes. After 5 minutes have elapsed, the Schirmer strip will be removed. The length of the moistened area will be recorded (mm) for each eye. A normal reading is ≥10 mm wetting of the paper after 5 minutes. Tear deficiency is \<5 mm wetting of the paper after 5 minutes. |
| Secondary | Cochet-Bonnet Corneal Sensitivity Test | Day 29 | After extending the Cochet-Bonnet corneal sensitivity device (containing a thin, retractable, nylon monofilament) up to 6 cm in length and pressing against the cornea, the monofilament is slowly retracted incrementally in 0.5 cm steps until the patient can feel its contact and the length is recorded. The greater the length indicates increased sensation and the shorter the length indicates decreased sensation. |
| Secondary | Tear Osmolarity | Day 29 | Normal tear osmolarity is defined as \< 300 mOsm/L in both eyes and an inter-eye difference of \< 8 mOsm/L. Values greater than 300 mOsm/L are suggestive of dry eye. |
| Secondary | Matrix Metalloprotienase-9 (MMP-9) is a Marker of Inflammation. | Day 29 | Levels of MMP-9 will be measured in each eye using InflammaDry at Visit 5. The test will be recorded as either positive or negative. Dry eye patients generally exhibit positive levels of MMP-9., so the number of subjects testing positive for MMP-9 at Day 29 will be recorded. |
| Secondary | Ocular Discomfort (Scale 1) | Day 29 | Ocular discomfort scores will be subjectively graded by the subjects according to the following scale, rating each eye separately on a scale from 0-4. A score of "0" represents no discomfort and a score of "4" represents constant discomfort. A minimum score would be "0" and a maximum score would be "8". The higher the value the worse the outcome. |
| Secondary | Ocular Discomfort (Scale 2) | Day 29 | Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel: overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst. A minimum score would be "0" and a maximum score would be "10". The higher the value the worse the outcome. |
| Secondary | Visual Analog Scale for Pain | Day 29 | Standard scale assessing a patient's level of pain on a scale of 0-100. The subject will be asked to rate each ocular symptom due to ocular dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0% corresponds to "no discomfort" and 100% corresponds to "maximal discomfort". The following parameters will be assessed: burning/stinging, itching, foreign body sensation, blurred vision, eye dryness, photophobia, and pain, with a total score for each eye reported. A minimal score would be "0" and a maximum score would be "200". The higher the value the worse the outcome. |
| Secondary | Fluorescein Staining | Day 29 | The following regions of each eye will be assessed for fluorescein staining: inferior, superior, central, corneal sum, temporal, nasal, conjunctival sum, and a total eye score recorded. A score of "0" represents no staining and a score of "4" represents confluent staining. A minimum score would be "0" and a maximum score would be "8". A higher values represent a worse outcome. |
| Secondary | Visual Acuity Measured by Assessing Average Change in LogMAR Units for Both Eyes at Day 29. LogMAR Units Range From 0-1.0, With the Higher the Number Indicating a Worsening in Vision. | Day 29 | Mean change in visual acuity (LogMAR units 0-1.0) for both eyes at Day 29 was determined for each treatment arm and considered a measure of safety. |
| Other | Number of Participants With Treatment-related Adverse Events | Adverse events will be collected from first dose of study drug to 30 days after treatment discontinuation (Day 29 + 4 weeks). | An adverse event is defined as any untoward medical occurrence associated with the use of the investigational agent (or placebo) regardless of whether or not it is considered related to the investigational drug (or placebo). |
| Other | Slit-lamp Biomicroscopy | Day 29 | The binocular slit-lamp examination provides a stereoscopic magnified view of the eye structures in detail, enabling anatomical diagnoses to be made of the cornea, conjunctiva, anterior chamber, iris, lens and lid for both eyes. The number of subjects in each treatment arm that have changes in the cornea, conjunctiva, anterior chamber, iris, lens and lid for both eyes at Day 29 will be reported. |
| Other | Intraocular Pressure | Day 29 | Intraocular pressure is the fluid pressure inside the eye. |
| Other | Dilated Fundoscopy | Day 29 | Dilated fundus examination is a diagnostic procedure that employs the use of mydriatic eye drops to dilate the pupil in order to obtain a better view of the fundus of the eye. The number of subjects that demonstrate clinically significant abnormalities in the vitreous, choroid, macula, and optic nerve at Day 29 in either treatment arm will be reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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