Trial · NCT03578276

Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

NCT03578276, Phase 4, Completed, Carolina Eyecare Physicians, LLC; results first posted 2022-06-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen. Trials, record NCT03578276. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03578276

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen
NCT number: NCT03578276
Status: Completed
Phases: Phase 4
Enrollment: 35 participants, actual
Lead sponsor: Carolina Eyecare Physicians, LLC
Conditions: Cataract
Interventions: Pred-Gati-Brom, Prednisolone acetate 1% ophthalmic suspension, Gatifloxacin Ophthalmic, Bromfenac 0.075% Oph Solution
First posted: 2018-07-06
Last updated: 2022-06-10
Results first posted: 2022-06-10

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline (Preoperative Exam) in Macular Thickness	Month 1	Thickness of the macula measured in microns, recorded as the change from baseline.
Secondary	Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)	Month 1	Thickness of the cornea measured in microns, measured as the change from baseline
Secondary	Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)	Month 1	Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change From Baseline (Preoperative Exam) in Macular Thickness	Month 1	microns	MEAN
SECONDARY	Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)	Month 1	microns	MEAN
SECONDARY	Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)	Month 1	mmHg	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline (Preoperative Exam) in Macular Thickness	LessDrops	4.91	Standard Deviation 8.46	microns
Change From Baseline (Preoperative Exam) in Macular Thickness	Standard of Care	1.30	Standard Deviation 4.13	microns
Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)	LessDrops	3.18	Standard Deviation 20.46	microns
Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)	Standard of Care	0.63	Standard Deviation 18.37	microns
Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)	LessDrops	-0.33	Standard Deviation 3.35	mmHg
Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)	Standard of Care	-0.21	Standard Deviation 3.37	mmHg

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Units counted
Overall Study	STARTED	LessDrops	35	35
Overall Study	STARTED	Standard of Care	35	35
Overall Study	COMPLETED	LessDrops	33	33
Overall Study	COMPLETED	Standard of Care	33	33
Overall Study	NOT COMPLETED	LessDrops	2	2
Overall Study	NOT COMPLETED	Standard of Care	2	2

Source ClinicalTrials.gov

Adverse events8

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	High intraocular pressure	Eye disorders	LessDrops	1	33
other	High intraocular pressure	Eye disorders	Standard of Care	2	33
other	Rebound inflammation	Eye disorders	LessDrops	1	33
other	Rebound inflammation	Eye disorders	Standard of Care	2	33
other	Macular edema	Eye disorders	LessDrops	0	33
other	Macular edema	Eye disorders	Standard of Care	1	33
other	Punctate epithelial erosions	Eye disorders	LessDrops	0	33
other	Punctate epithelial erosions	Eye disorders	Standard of Care	1	33

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	LessDrops	0	33
Total, all-cause mortality	Standard of Care	0	33
Total, other adverse events	LessDrops	2	33
Total, other adverse events	Standard of Care	6	33
Total, serious adverse events	LessDrops	0	33
Total, serious adverse events	Standard of Care	0	33

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
LessDrops vs Standard of Care: deaths from any cause	Trial comparisons
LessDrops vs Standard of Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03578276

GET https://conductscience.org/api/trials/v1/NCT03578276/registered

API reference For AI assistants