Cataract Surgery Clinical Trial
Official title:
A Randomized, Double-masked, Parallel Group Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery (Levofloxacin 0.5% Ophthalmic Solution as a Comparator) - Phase III, Confirmatory Study of Perioperative Bacteria Eradication -
Verified date | October 2017 |
Source | Santen Pharmaceutical Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate superior efficacy of DE-108 ophthalmic solution to that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for perioperative bacteria eradication in patients who are scheduled for cataract surgery.
Status | Completed |
Enrollment | 576 |
Est. completion date | March 31, 2017 |
Est. primary completion date | March 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Those who are scheduled for cataract surgery Exclusion Criteria: - Those who with suspected ocular infections based on clinical findings in the study eye. - Those who have any eye disease other than cataract which requires treatment in the target eye. - Those who have a history of allergy to the drugs to be used during the clinical study (such as fluoroquinolones, topical anesthetics and povidon iodine) - Those who need to wear contact lenses during the study period |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyungpook National University Hospital | Kyungpook | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Kim's eye Hospital | Seoul | |
Korea, Republic of | Seoul National University Bundang Hospital | Seoul | |
Korea, Republic of | Seoul Saint Marry's Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul |
Lead Sponsor | Collaborator |
---|---|
Santen Pharmaceutical Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the percentage of positive bacteriological test results (from Day -3 to Day 0) | 3 days (Day -3 to Day0) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02910362 -
Intra-surgical Evaluation of CATS Tonometer Prism and Abbott Medical Optics Versus Alcon Phacoemulsification Machines
|
N/A | |
Recruiting |
NCT01193504 -
Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification
|
Phase 4 | |
Completed |
NCT01199510 -
Efficacy Evaluation of SYSTANE® ULTRA in Patients Scheduled for Cataract Surgery
|
Phase 4 | |
Completed |
NCT01455233 -
2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery
|
Phase 4 | |
Completed |
NCT04146961 -
The PanOptix Trifocal IOL: A Study of Patient Satisfaction, Visual Disturbances, and Uncorrected Visual Performance
|
||
Completed |
NCT00585975 -
Efficacy and Safety of Bromfenac Ophthalmic Solution
|
Phase 2 | |
Completed |
NCT00406913 -
Prophylaxis Prior to Cataract Surgery Conjunctival Flora and Optimal Ocular Sterilization Technique Prior to Cataract Surgery
|
N/A | |
Not yet recruiting |
NCT04131335 -
Use of Prophylactic Lubricating Drops After Cataract Surgery
|
N/A | |
Recruiting |
NCT05331690 -
Cataract Surgery and Inflammation - the Role for Preoperative NSAIDs (Pre-CIN)
|
Phase 4 | |
Withdrawn |
NCT04563559 -
PREFERENTIAL Study
|
Phase 2/Phase 3 | |
Completed |
NCT04732351 -
Evaluation of the Active Sentry System During Cataract Surgery With the Centurion Phacoemulsifier
|
||
Completed |
NCT02128113 -
RTA 408 Ophthalmic Suspension for the Prevention of Corneal Endothelial Cell Loss Following Cataract Surgery - GUARD
|
Phase 2 | |
Completed |
NCT03873454 -
The Effects of Music on Perioperative Outcomes in Cataract Surgery
|
N/A | |
Completed |
NCT04769856 -
Impact of Non-fasting on Anxiety in Cataract Surgery
|
N/A | |
Withdrawn |
NCT00604305 -
Comperative Trial Between an Accommodative Iol and Monofocal Iol
|
N/A | |
Completed |
NCT05925894 -
Efficacy Mydrane ® for Cataract Surgery in Patients With Concomitant Primary Open Angle Glaucoma.
|
N/A | |
Not yet recruiting |
NCT06136780 -
Impact of Free Reading Glasses on Work and Visual Function Following Cataract Surgery in Honduras
|
N/A | |
Completed |
NCT04633954 -
Brimonidine for Subconjunctival Hemorrhage From Femtosecond Laser Assisted Cataract Surgery
|
N/A | |
Completed |
NCT03644875 -
Study of Etacoat in Patients With Cataract Surgery Via the Anterior Chamber
|
||
Recruiting |
NCT04781231 -
Impact of Music Added to the Usual Treatment on the Anxiety of Patients Undergoing Outpatient Cataract Surgery With Topical Anesthesia
|
N/A |