Trial Outcomes & Findings for Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus (NCT NCT04418999)

Last Updated: 2025-04-06

Results Overview

For patients with keratoconus who wear contact lenses and suffer with allergies Ocular Surface Disease Index (OSDI) questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, and intraocular pressures (IOP) will be taken at each visit The primary outcome measure is papillary grade. This is measured on a grading scale of 0-4. Grade 0 is the lowest score, meaning no papillae are present. Grade 4 is the worse score. Papillary grade scale = 0-4 (grade 4 is worse score)

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

36 participants

Primary outcome timeframe

90 days

Results posted on

2025-04-06

Participant Flow

There were 36 eyes completed

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Dexamethasone Insert Per participant, one eye will be randomized to receive the intracanalicular dexamethasone insert at the baseline visit (study eye). DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus at the day 1 visit by pulling the lower lid taught and using a forceps to insert the medication into the lower canaliculus through the lower punctum. dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use: Experimental	Loteprednol Etabonate Ophthalmic Gel 0.38% Per participant, one eye will be randomized to receive the standard of care topical lotemax etabonate ophthalmic gel 0.38% (control eye). Patients will be prescribed a loteprednol etabonate ophthalmic gel 0.38% and will instill one drop into the eye following a 4x/day,3x/day,2x/day,1/xday weekly taper Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly: Active Comparator
Overall Study STARTED	18 18	18 18
Overall Study COMPLETED	18 18	18 18
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone Insert n=18 eyes Per participant, one eye will be randomized to receive the intracanalicular dexamethasone insert at the baseline visit (study eye). DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus at the day 1 visit by pulling the lower lid taught and using a forceps to insert the medication into the lower canaliculus through the lower punctum. dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use: Experimental	Loteprednol Etabonate Ophthalmic Gel 0.38% n=18 eyes Per participant, one eye will be randomized to receive the standard of care topical lotemax etabonate ophthalmic gel 0.38% (control eye). Patients will be prescribed a loteprednol etabonate ophthalmic gel 0.38% and will instill one drop into the eye following a 4x/day,3x/day,2x/day,1/xday weekly taper Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly: Active Comparator	Total n=36 eyes Total of all reporting groups
Age, Categorical <=18 years	0 eyes n=32 eyes	0 eyes n=16 eyes	0 eyes n=48 eyes
Age, Categorical Between 18 and 65 years	15 eyes n=32 eyes	15 eyes n=16 eyes	30 eyes n=48 eyes
Age, Categorical >=65 years	3 eyes n=32 eyes	3 eyes n=16 eyes	6 eyes n=48 eyes
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=32 eyes	18 participants n=16 eyes	18 participants n=48 eyes
Count of eyes	18 eyes n=32 eyes	18 eyes n=16 eyes	36 eyes n=48 eyes

PRIMARY outcome

Timeframe: 90 days

Population: 18 eyes per arm/group analyzed (36 eyes total/18 participants total)

Outcome measures

Outcome measures
Measure	Dexamethasone Insert n=18 eyes Per participant, one eye will be randomized to receive the intracanalicular dexamethasone insert at the baseline visit (study eye). DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus at the day 1 visit by pulling the lower lid taught and using a forceps to insert the medication into the lower canaliculus through the lower punctum. dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use: Experimental	Loteprednol Etabonate Ophthalmic Gel 0.38% n=18 eyes Per participant, one eye will be randomized to receive the standard of care topical lotemax etabonate ophthalmic gel 0.38% (control eye). Patients will be prescribed a loteprednol etabonate ophthalmic gel 0.38% and will instill one drop into the eye following a 4x/day,3x/day,2x/day,1/xday weekly taper Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly: Active Comparator
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Allergies	1.67 papillary grade Standard Deviation 0.67	2 papillary grade Standard Deviation 0.76

PRIMARY outcome

Timeframe: 90 days

Population: 18 eyes per arm/group

For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, and IOP will be taken at each visit. This outcome is measuring Osmolarity which is measured on a scale in units of milliosmoles. The scale measured is between 250-400 with the higher number being the worse score.

Outcome measures

Outcome measures
Measure	Dexamethasone Insert n=18 eyes Per participant, one eye will be randomized to receive the intracanalicular dexamethasone insert at the baseline visit (study eye). DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus at the day 1 visit by pulling the lower lid taught and using a forceps to insert the medication into the lower canaliculus through the lower punctum. dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use: Experimental	Loteprednol Etabonate Ophthalmic Gel 0.38% n=18 eyes Per participant, one eye will be randomized to receive the standard of care topical lotemax etabonate ophthalmic gel 0.38% (control eye). Patients will be prescribed a loteprednol etabonate ophthalmic gel 0.38% and will instill one drop into the eye following a 4x/day,3x/day,2x/day,1/xday weekly taper Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly: Active Comparator
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus Who Also Have Elevated Osmolarity	297.8 milliosmoles Standard Deviation 31.6	304.5 milliosmoles Standard Deviation 21.6

PRIMARY outcome

Timeframe: 90 days

Population: 18 eyes per arm/group

For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, and IOP will be taken at each visit. This specific measure is measuring intraocular pressure by method of Goldman applanation tonometry. This is measured as a unit measure in units of mmHg between 10-22mmHg.

Outcome measures

Outcome measures
Measure	Dexamethasone Insert n=18 eyes Per participant, one eye will be randomized to receive the intracanalicular dexamethasone insert at the baseline visit (study eye). DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus at the day 1 visit by pulling the lower lid taught and using a forceps to insert the medication into the lower canaliculus through the lower punctum. dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use: Experimental	Loteprednol Etabonate Ophthalmic Gel 0.38% n=18 eyes Per participant, one eye will be randomized to receive the standard of care topical lotemax etabonate ophthalmic gel 0.38% (control eye). Patients will be prescribed a loteprednol etabonate ophthalmic gel 0.38% and will instill one drop into the eye following a 4x/day,3x/day,2x/day,1/xday weekly taper Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly: Active Comparator
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Intraocular Pressure	14.7 mmHg Standard Deviation 3.1	15.1 mmHg Standard Deviation 3.1

PRIMARY outcome

Timeframe: 90 days

Population: 18 eyes per arm/group

For patients with keratoconus who wear contact lenses and suffer with allergies OSDI questionnaire will be taken, grading of hyperemia, papillary reaction, corneal staining, and IOP will be taken at each visit. tear-break-up time is measured on a scale of 0-4, the higher the number, the worse the score corneal staining is measured on a scale of 0-4, the higher the number the worse the score

Outcome measures

Outcome measures
Measure	Dexamethasone Insert n=18 eyes Per participant, one eye will be randomized to receive the intracanalicular dexamethasone insert at the baseline visit (study eye). DEXTENZA is an ophthalmic insert that is inserted in the lower lacrimal punctum into the canaliculus at the day 1 visit by pulling the lower lid taught and using a forceps to insert the medication into the lower canaliculus through the lower punctum. dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use: Experimental	Loteprednol Etabonate Ophthalmic Gel 0.38% n=18 eyes Per participant, one eye will be randomized to receive the standard of care topical lotemax etabonate ophthalmic gel 0.38% (control eye). Patients will be prescribed a loteprednol etabonate ophthalmic gel 0.38% and will instill one drop into the eye following a 4x/day,3x/day,2x/day,1/xday weekly taper Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly: Active Comparator
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Dry Eye Tear Break-Up-Time (scale 0-4)	3.4 score on a scale Standard Deviation 1.7	3.6 score on a scale Standard Deviation 1.8
Determine the Effect of Dexamethasone Intracanalicular Insert on Patients With Keratoconus and Dry Eye Corneal Staining (Scale 0-4)	5.0 score on a scale Standard Deviation 2.2	5.2 score on a scale Standard Deviation 2.1

Adverse Events

Dexamethasone Insert

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Loteprednol Etabonate Ophthalmic Gel 0.38%

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

Jennifer Harthan

Illinois College of Optometry

Phone: 3129497249

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place