Trial Outcomes & Findings for Effect of Intraoperative Dexamethasone on Post-op Dry Eye (NCT NCT04184999)

Last Updated: 2023-11-22

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

3 weeks

Results posted on

2023-11-22

Participant Flow

patients scheduled to undergo bilateral cataract surgery 40 participants were enrolled, each eye was randomized to 2 different treatment groups (intracameral dexamethasone + postoperative topical prednisolone or postoperative topical prednisolone alone)

patients scheduled to undergo bilateral cataract surgery were randomly assigned to receive an intracameral injection of dexamethasone + a standard postoperative topical steroid regimen in one eye, and a standard postoperative topical steroid regimen in the other eye. Preoperative and postoperative signs of dry eye were compared between the two groups

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Intracameral Dexamethasone + Postoperative Topical Prednisolone dexamethasone intraocular suspension, 9% + topical ophthalmic prednisolone dexamethasone intraocular suspension, 9%: single dose intracameral corticosteroid Prednisolone Acetate: topical ophthalmic drop for 3 weeks	Postoperative Topical Prednisolone postoperative topical prednisolone for 3 weeks
Overall Study STARTED	40 40	40 40
Overall Study 3 Week Tear Film Osmolarity Testing	40 40	40 40
Overall Study COMPLETED	40 40	40 40
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intracameral Dexamethasone + Post-operative Topical Prednisolone n=40 eyes dexamethasone intraocular suspension, 9% + topical ophthalmic prednisolone dexamethasone intraocular suspension, 9%: single dose intracameral corticosteroid Prednisolone Acetate: topical ophthalmic drop	Post-operative Topical Prednisolone n=40 eyes topical ophthalmic prednisolone acetate Prednisolone Acetate: topical ophthalmic drop	Total n=80 eyes Total of all reporting groups
Age, Categorical <=18 years	1 eyes n=40 eyes	1 eyes n=40 eyes	2 eyes n=80 eyes
Age, Categorical Between 18 and 65 years	15 eyes n=40 eyes	15 eyes n=40 eyes	30 eyes n=80 eyes
Age, Categorical >=65 years	24 eyes n=40 eyes	24 eyes n=40 eyes	48 eyes n=80 eyes
Age, Continuous	67.49 years STANDARD_DEVIATION 10.42 • n=40 eyes	67.49 years STANDARD_DEVIATION 10.42 • n=40 eyes	67.49 years STANDARD_DEVIATION 10.42 • n=80 eyes
Sex: Female, Male Female	22 eyes n=40 eyes	22 eyes n=40 eyes	44 eyes n=80 eyes
Sex: Female, Male Male	18 eyes n=40 eyes	18 eyes n=40 eyes	36 eyes n=80 eyes
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	40 eyes n=40 eyes	40 eyes n=40 eyes	80 eyes n=80 eyes
Preoperative Tear Film Osmolarity	307.475 mOsmo/L n=40 eyes	307.775 mOsmo/L n=40 eyes	307.625 mOsmo/L n=80 eyes

PRIMARY outcome

Timeframe: 3 weeks

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

Outcome measures

Outcome measures
Measure	Intracameral Dexamethasone n=40 eyes intracameral dexamethasone + postoperative prednisolone acetate for 3 weeks	Postoperative Prednisolone Acetate n=40 eyes postoperative prednisolone acetate for 3 weeks
Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively	311.15 mOsmol/L Interval 284.0 to 333.0	316.3 mOsmol/L Interval 286.0 to 335.0

Adverse Events

Intracameral Dexamethasone + Postoperative Prednisolone Acetate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Postoperative Prednisolone Acetate Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sanjay Rao

SR Cornea Consultants

Phone: 8476685498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place