Trial Outcomes & Findings for The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED (NCT NCT02120079)

Results Overview

Density (in cells/mm\^2) of Corneal Immune Dendritiform Cells

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

37 participants

Primary outcome timeframe

2 Weeks

Results posted on

2024-06-26

Participant Flow

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Lotemax Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Baseline STARTED	17 28	20 34
Baseline COMPLETED	17 28	20 34
Baseline NOT COMPLETED	0 0	0 0
2 Weeks STARTED	17 28	20 34
2 Weeks COMPLETED	17 28	20 34
2 Weeks NOT COMPLETED	0 0	0 0
6 Weeks STARTED	17 28	20 34
6 Weeks COMPLETED	17 28	20 34
6 Weeks 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	Lotemax n=28 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=34 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Total n=62 Eyes Total of all reporting groups
Age, Continuous	57.29 years STANDARD_DEVIATION 12.62 • n=17 Participants	55.35 years STANDARD_DEVIATION 15.78 • n=20 Participants	56.24 years STANDARD_DEVIATION 14.25 • n=37 Participants
Sex: Female, Male Female	12 Participants n=17 Participants	17 Participants n=20 Participants	29 Participants n=37 Participants
Sex: Female, Male Male	5 Participants n=17 Participants	3 Participants n=20 Participants	8 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Corneal immune dendritiform cell (DC) density at Baseline	26.83 cells/mm^2 STANDARD_DEVIATION 14.98 • n=28 Eyes	34.59 cells/mm^2 STANDARD_DEVIATION 29.15 • n=34 Eyes	30.97 cells/mm^2 STANDARD_DEVIATION 23.76 • n=62 Eyes
Corneal immune dendritiform cell (DC) morphology at Baseline	90.79 cells/mm2 STANDARD_DEVIATION 16.67 • n=28 Eyes	92.29 cells/mm2 STANDARD_DEVIATION 23.82 • n=34 Eyes	91.59 cells/mm2 STANDARD_DEVIATION 20.64 • n=62 Eyes
Corneal fluorescein staining at Baseline	3.39 Score STANDARD_DEVIATION 2.50 • n=28 Eyes	4.06 Score STANDARD_DEVIATION 3.27 • n=34 Eyes	3.76 Score STANDARD_DEVIATION 2.94 • n=62 Eyes
Ocular Symptoms Disease Index (OSDI) at Baseline	56.93 Score STANDARD_DEVIATION 29.36 • n=17 Participants	38.46 Score STANDARD_DEVIATION 20.34 • n=20 Participants	47.18 Score STANDARD_DEVIATION 26.35 • n=37 Participants
Lissamine Green at Baseline	3.57 Score STANDARD_DEVIATION 2.71 • n=28 Eyes	5.74 Score STANDARD_DEVIATION 4.26 • n=34 Eyes	4.76 Score STANDARD_DEVIATION 3.78 • n=62 Eyes
Intraocular Pressure (IOP) at Baseline	14.50 mmHG STANDARD_DEVIATION 3.18 • n=28 Eyes	14.97 mmHG STANDARD_DEVIATION 2.46 • n=34 Eyes	14.76 mmHG STANDARD_DEVIATION 2.79 • n=62 Eyes
Tear Break-Up Time (TBUT) at Baseline	3.99 Seconds STANDARD_DEVIATION 2.18 • n=28 Eyes	4.17 Seconds STANDARD_DEVIATION 3.30 • n=34 Eyes	4.09 Seconds STANDARD_DEVIATION 2.82 • n=62 Eyes
Schirmer's at Baseline	10.44 mm STANDARD_DEVIATION 8.94 • n=28 Eyes	10.57 mm STANDARD_DEVIATION 9.35 • n=34 Eyes	10.51 mm STANDARD_DEVIATION 9.09 • n=62 Eyes

PRIMARY outcome

Timeframe: 2 Weeks

Density (in cells/mm\^2) of Corneal Immune Dendritiform Cells

Outcome measures

Outcome measures
Measure	Lotemax n=17 Participants Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=34 eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
IVCM for Density of Corneal Immune Dendritiform Cells	9.47 cells/mm^2 Standard Deviation 5.13	28.60 cells/mm^2 Standard Deviation 26.09

PRIMARY outcome

Timeframe: 6 Weeks

Density (in cells/mm\^2) of corneal immune dendritiform cells

Outcome measures

Outcome measures
Measure	Lotemax n=24 eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=34 eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
IVCM for Density of Corneal Immune Dendritiform Cells	9.80 cells/mm^2 Standard Deviation 5.10	34.03 cells/mm^2 Standard Deviation 31.92

PRIMARY outcome

Timeframe: 2 Weeks

Morphology (in cells/mm\^2) of Corneal Immune Dendritiform Cells

Outcome measures

Outcome measures
Measure	Lotemax n=28 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=34 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
IVCM for Corneal Immune Dendritiform Cell (DC) Morphology	109.50 cells/mm^2 Standard Deviation 40.56	97.95 cells/mm^2 Standard Deviation 30.92

PRIMARY outcome

Timeframe: 6 Weeks

Morphology (in cells/mm\^2) of Corneal Immune Dendritiform Cells

Outcome measures

Outcome measures
Measure	Lotemax n=24 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=34 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
IVCM for Corneal Immune Dendritiform Cell (DC) Morphology	102.31 Cells/mm^2 Standard Deviation 26.25	89.34 Cells/mm^2 Standard Deviation 24.73

SECONDARY outcome

Timeframe: 2 Weeks

Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome

Outcome measures

Outcome measures
Measure	Lotemax n=28 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=34 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Signs: Corneal Epitheliopathy	1.86 Score Standard Deviation 2.12	3.18 Score Standard Deviation 2.55

SECONDARY outcome

Timeframe: 6 Weeks

Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome

Outcome measures

Outcome measures
Measure	Lotemax n=26 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=34 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Signs: Corneal Epitheliopathy	2.00 Score Standard Deviation 1.98	3.59 Score Standard Deviation 2.75

SECONDARY outcome

Timeframe: 2 Weeks

Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome

Outcome measures

Outcome measures
Measure	Lotemax n=28 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=32 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Signs: Conjunctival Epitheliopathy	3.79 Score Standard Deviation 3.47	4.50 Score Standard Deviation 4.13

SECONDARY outcome

Timeframe: 6 Weeks

Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome

Outcome measures

Outcome measures
Measure	Lotemax n=26 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=34 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Signs: Conjunctival Epitheliopathy	2.46 Score Standard Deviation 1.86	3.44 Score Standard Deviation 3.55

SECONDARY outcome

Timeframe: 2 Weeks

Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome

Outcome measures

Outcome measures
Measure	Lotemax n=17 Participants Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=19 Participants Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire	47.25 Score Standard Deviation 27.36	33.16 Score Standard Deviation 23.55

SECONDARY outcome

Timeframe: 6 Weeks

Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome

Outcome measures

Outcome measures
Measure	Lotemax n=16 Participants Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=20 Participants Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire	46.63 Score Standard Deviation 29.15	36.04 Score Standard Deviation 23.30

SECONDARY outcome

Timeframe: 2 Weeks

Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg

Outcome measures

Outcome measures
Measure	Lotemax n=27 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=32 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry	15.52 mmHg Standard Deviation 2.87	14.50 mmHg Standard Deviation 3.32

SECONDARY outcome

Timeframe: 6 Weeks

Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg

Outcome measures

Outcome measures
Measure	Lotemax n=26 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=34 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry	16.88 mmHg Standard Deviation 2.30	13.76 mmHg Standard Deviation 3.32

SECONDARY outcome

Timeframe: 2 Weeks

Tear Break Up Time (TBUT) will be recorded in seconds

Outcome measures

Outcome measures
Measure	Lotemax n=28 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=32 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Signs: Tear Break Up Time (TBUT)	5.20 Seconds Standard Deviation 3.48	3.93 Seconds Standard Deviation 1.91

SECONDARY outcome

Timeframe: 6 Weeks

Tear Break Up Time (TBUT) will be recorded in seconds

Outcome measures

Outcome measures
Measure	Lotemax n=26 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=34 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Signs: Tear Break Up Time (TBUT)	4.83 Seconds Standard Deviation 3.68	3.44 Seconds Standard Deviation 2.04

SECONDARY outcome

Timeframe: 2 Weeks

The Schirmer's Test (performed using Anesthesia) will be measured in mm.

Outcome measures

Outcome measures
Measure	Lotemax n=28 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=32 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Signs: Schirmer's Test With Anesthesia	7.98 mm Standard Deviation 4.98	6.88 mm Standard Deviation 5.92

SECONDARY outcome

Timeframe: 6 Weeks

The Schirmer's Test (performed using Anesthesia) will be measured in mm.

Outcome measures

Outcome measures
Measure	Lotemax n=25 Eyes Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) n=34 Eyes Soothe Tired Eyes Lubricant Eye Drop (Bausch \& Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Ocular Signs: Schirmer's Test With Anesthesia	8.16 mm Standard Deviation 4.78	8.18 mm Standard Deviation 6.06

Adverse Events

Lotemax

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)

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. Pedram Hamrah

Tufts Medical Center

Phone: 617-636-5321

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place