Effect of Intraoperative Dexamethasone on Post-op Dry Eye

NCT04184999 | Completed Phase 4 Results FDA Drug

• 1 other identifier: SRCC10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively

  Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L)

  3 weeks

Study Arms (2)

Intracameral dexamethasone 9% + postoperative topical prednisolone acetate

EXPERIMENTAL

dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively

Drug: dexamethasone intraocular suspension, 9%; Drug: Prednisolone Acetate 1% Oph Susp

postoperative topical prednisolone acetate

ACTIVE COMPARATOR

topical ophthalmic prednisolone acetate for 3 weeks post-operatively

Drug: Prednisolone Acetate 1% Oph Susp

Interventions

dexamethasone intraocular suspension, 9% DRUG

single dose intracameral corticosteroid

Also known as: Dexycu

Intracameral dexamethasone 9% + postoperative topical prednisolone acetate

Prednisolone Acetate 1% Oph Susp DRUG

topical ophthalmic steroid drop

Intracameral dexamethasone 9% + postoperative topical prednisolone acetate; postoperative topical prednisolone acetate

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing bilateral cataract surgery

You may not qualify if:

• central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye

Sponsors & Collaborators

• SR Cornea Consultants: lead

Study Sites (1)

Hauser Ross Surgical Center

Sycamore, Illinois, 60178, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Calcium Dobesilate; prednisolone acetate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Sanjay Rao
• Organization: SR Cornea Consultants

sanjaynraomd@gmail.com

8476685498

Study Officials

• Sanjay Rao, MD

  SR Cornea Conslutants

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized, controlled prospective study.

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 4, 2019
• Study Start: August 10, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 22, 2023
• Results First Posted: January 29, 2021

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)