Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT01313351
Brief Summary:
The RPS InflammaDry Detector™ is intended to detect elevated MMP-9 in human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
Detailed Description:
The purpose of this clinical trial was to determine the sensitivity and specificity of InflammaDry compared with the clinical assessment of dry eyes.
Patients were screened using clinical history and signs.
Clinical history was performed using the Ocular Surface Disease Index (OSDI) and evaluated for clinical signs:
* positive vital staining of the ocular surface,
* decreased tear breakup time (TBUT),
* reduced corneal sensitivity, and
* decreased functional visual acuity Last, an independent health care professional masked to the clinical evaluation was asked to analyze each InflammaDry test result, independently confirming each result.
Study:
NCT01313351
Study Brief:
Protocol Section:
NCT01313351