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Clinical trial

Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye

ID
Name
SRCC10
Description
To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.
Trial arms
Trial start
2019-08-10
Estimated PCD
2019-12-01
Trial end
2019-12-01
Status
Completed
Phase
Early phase I
Treatment
dexamethasone intraocular suspension, 9%
single dose intracameral corticosteroid
Arms:
Intracameral dexamethasone 9% + postoperative topical prednisolone acetate
Other names:
Dexycu
Prednisolone Acetate 1% Oph Susp
topical ophthalmic steroid drop
Arms:
Intracameral dexamethasone 9% + postoperative topical prednisolone acetate, postoperative topical prednisolone acetate
Size
40
Primary endpoint
Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
3 weeks
Eligibility criteria
Inclusion Criteria: * undergoing bilateral cataract surgery Exclusion Criteria: * central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled prospective study.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-11-22

1 organization

2 products

1 indication

Organization
SR Cornea Consultants
Product
Dexamethasone
Indication
Dry Eye Syndrome
Product
Prednisolone Acetate