Dry Eye Disease Clinical Trial
Official title:
Burden of Illness and Treatment Assessment of Patients With Dry Eye Disease: A Cross-Sectional Survey of Real-World Patients With Dry Eye Disease in the US
NCT number | NCT06018571 |
Other study ID # | CLIF606A1US10 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2, 2022 |
Est. completion date | August 19, 2022 |
Verified date | August 2023 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study employed secondary database analysis of the Adelphi Dry Eye Disease (DED) Disease Specific Programme™ (DSP™), a templatized cross-sectional survey with retrospective data collection that is administered by Adelphi to a convenience sample of patients diagnosed with DED, and their consulting physicians in the United States. In addition to the survey data, the DED DSP also included recorded medical history data as reported by physicians (optometrists, ophthalmologists or refractive surgeons).
Status | Completed |
Enrollment | 946 |
Est. completion date | August 19, 2022 |
Est. primary completion date | August 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Main Sample: - = 18 years of age. - Physician-confirmed DED diagnosis (at time of data collection). Xiidra® Oversample: - = 18 years of age. - Physician-confirmed DED diagnosis (at time of data collection). - Have a current prescription for Xiidra® for their DED (at time of data collection). Exclusion Criteria: Main Sample: • Involved in a DED clinical trial (at time of data collection). Xiidra® Oversample: - Involved in a DED clinical trial (at time of data collection). - Included in the main sample previously. |
Country | Name | City | State |
---|---|---|---|
United States | Novartis | East Hanover | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Impact of Dry Eye on Everyday Life questionnaire© (IDEEL) mean scores | Mean IDEEL score on Symptom Bother dimension: score range 0-100, where higher scores indicate greater bother. Mean IDEEL scores on Daily Activities, Emotional Impact, and Work dimensions: score range 0-100, where higher scores indicate lesser impact. | Up to approximately 18 months | |
Primary | Work Productivity and Activity Impairment© (WPAI) mean scores | A higher score on the WPAI indicates greater impairment and loss of productivity. | Up to approximately 18 months | |
Primary | Frequency of consultations | Up to approximately 18 months | ||
Primary | Frequency of DED-related hospitalizations | Up to approximately 18 months | ||
Primary | Number of emergency room (ER)/intensive care unit (ICU) admittances | Up to approximately 18 months | ||
Primary | Duration of ER/ICU admittances | Up to approximately 18 months | ||
Primary | Number of evaluations/tests administered | Up to approximately 18 months | ||
Primary | Frequency of evaluations/tests administered | Up to approximately 18 months | ||
Secondary | Number of patients with reasons for consultation, per category | Up to approximately 18 months | ||
Secondary | Number of patients with current (at time of data capture) treatment regimen (prescribed, over-the-counter [OTC] treatments) | Up to approximately 18 months | ||
Secondary | Number of patients with reasons for not currently receiving any treatment for patient's DED (where appropriate), per category | Up to approximately 18 months | ||
Secondary | Number of patients with reasons for switching away from previous treatment line (where appropriate), per category | Up to approximately 18 months | ||
Secondary | Number of patients with "other than cure their DED, the most important benefit a drug treatment could provide," per category | Up to approximately 18 months | ||
Secondary | Impact of Dry Eye on Everyday Life Treatment Satisfaction module© (IDEEL-TS©) mean score | Score range 0-100, where a higher score indicates greater satisfaction. | Up to approximately 18 months | |
Secondary | Number of physicians assessing reasons for choice of current treatment line, per category | Up to approximately 18 months | ||
Secondary | Number of physicians assessing areas of improvement for current treatment line, per category | Up to approximately 18 months | ||
Secondary | Number of patients for whom cost/reimbursement was a driving factor in selection of current treatment | Up to approximately 18 months | ||
Secondary | Number of patients who were adherent to their current treatment plan, per category, as assessed by the physician | Up to approximately 18 months | ||
Secondary | Number of patients who were compliant to their current treatment plan, per category, as assessed by the physician | Up to approximately 18 months | ||
Secondary | Number of physicians assessing attributes associated with ideal medication, per category | Up to approximately 18 months | ||
Secondary | Number of physicians assessing attributes associated with currently prescribed medication, per category | Up to approximately 18 months | ||
Secondary | Number of physicians assessing influences on treatment decisions, per category | Up to approximately 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03216096 -
Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease
|
Phase 1 | |
Completed |
NCT05825599 -
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
|
N/A | |
Completed |
NCT04656197 -
The Ocular Microbiome in Patients With Dry Eye Disease
|
||
Completed |
NCT05031806 -
Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease
|
Phase 1 | |
Completed |
NCT03688802 -
Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation
|
Phase 2 | |
Completed |
NCT05213156 -
Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease
|
Phase 4 | |
Completed |
NCT04548427 -
Study to Evaluate the Efficacy and Safety of CKD-352
|
Phase 3 | |
Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT02254265 -
Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
|
Phase 2/Phase 3 | |
Completed |
NCT00395759 -
The Visual Effect of an Investigational Artificial Tear in the Tear Layer.
|
N/A | |
Completed |
NCT00680108 -
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
|
Phase 2 | |
Recruiting |
NCT06064071 -
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
|
N/A | |
Completed |
NCT04139122 -
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06375343 -
Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®
|
Phase 1 | |
Completed |
NCT01468168 -
A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
|
Phase 2 | |
Completed |
NCT01014078 -
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
|
Phase 4 | |
Completed |
NCT00799682 -
Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z®
|
Phase 4 | |
Completed |
NCT05082974 -
Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK)
|
Phase 3 | |
Recruiting |
NCT06146881 -
Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia
|
Phase 2 | |
Completed |
NCT03292809 -
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
|
Phase 2/Phase 3 |