Trial Outcomes & Findings for Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease) (NCT NCT01817582)

Last Updated: 2019-08-30

Results Overview

Fluorescein Corneal Staining indicates the damage to the corneal epithelium (corneal epitheliopathy). Punctate corneal staining with fluorescein was evaluated and graded according to the National Eye Institute (NEI) grading method. The cornea was divided into 5 regions: central, superior, inferior, nasal and temporal. Each of these 5 regions was graded from scores 0 to 3, where 0 indicated no staining (absent) and 3 maximal staining (severe damage). The total score was the sum of all these regions, ranged from 0 (absence of corneal epitheliopathy) to 15 (severe corneal epitheliopathy).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

Baseline (Day 0), Week 4

Results posted on

2019-08-30

Participant Flow

A total of 102 participants were randomized in 1:1:1 to lotemax gel 0.5% and restasis 0.05%, lotemax gel 0.5%, or restasis 0.05% treatment groups.

Participant milestones

Participant milestones
Measure	Lotemax Gel 0.5% and Restasis 0.05% Participants administered lotemax gel (loteprednol etabonate ophthalmic gel) 0.5 percent (%) twice daily (BID) in both eyes (OU) for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion (cyclosporin ophthalmic emulsion) 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Overall Study STARTED	33	36	33
Overall Study Received at Least 1 Dose of Study Drug	33	36	33
Overall Study COMPLETED	31	35	33
Overall Study NOT COMPLETED	2	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotemax Gel 0.5% and Restasis 0.05% Participants administered lotemax gel (loteprednol etabonate ophthalmic gel) 0.5 percent (%) twice daily (BID) in both eyes (OU) for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion (cyclosporin ophthalmic emulsion) 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Overall Study Withdrawal by Subject	0	1
Overall Study Participant revealed masked treatment	1	0
Overall Study Randomized but exclusion criteria met	1	0

Baseline Characteristics

Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Total n=102 Participants Total of all reporting groups
Age, Continuous	62.0 years STANDARD_DEVIATION 8.30 • n=5 Participants	64.3 years STANDARD_DEVIATION 9.10 • n=7 Participants	61.6 years STANDARD_DEVIATION 9.98 • n=5 Participants	62.7 years STANDARD_DEVIATION 9.14 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	30 Participants n=7 Participants	26 Participants n=5 Participants	81 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0), Week 4

Population: ITT population included all randomized participants. Missing data was imputed using mixed-effect model for repeated measures (MMRM) method. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=32 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Corneal Total Fluorescein Staining Score at for the Study Eye at Week 4	-1.3 units on a scale Standard Deviation 1.95	-1.7 units on a scale Standard Deviation 2.89	-1.3 units on a scale Standard Deviation 1.63

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: ITT population included all randomized participants. Missing data was imputed using MMRM method. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

OSDI is a 12-item questionnaire developed to assess severity of DED. There are 3 question types: "Have you experienced any of following (light sensitivity, eye feel gritty, sore eyes, blurred vision, and poor vision) during last week?"(items 1-5); "Have problems with your eyes limited you in performing any of following (reading, driving at night, working with computer, and watching TV) during last week?" (items 6-9); and "Have your eyes felt uncomfortable in any of following situations (windy, low humidity, air conditioned) during the last week?" (items 10-12). Response of each of these questions were graded on a scale (that relate to the frequency of ocular surface disease effects) of 0 (none of the time) to 4 (all of the time).Total OSDI score was calculated using following formula: OSDI=(\[sum of scores for all questions answered\] × 100)/(\[total number of questions answered\] \* 4). Total OSDI score ranged from 0 to 100, with higher scores representing greater disability.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=32 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean Ocular Surface Disease Index (OSDI) Questionnaire Total Score at Week 4	-5.2 units on a scale Standard Deviation 12.84	-1.3 units on a scale Standard Deviation 17.04	-0.6 units on a scale Standard Deviation 14.09

PRIMARY outcome

Timeframe: Baseline up to Week 13

Population: Safety population included all randomized participants who received at least 1 dose of study drug.

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Percentage of Participants With Adverse Events (AEs)	27.3 percentage of participants	25.0 percentage of participants	27.3 percentage of participants

PRIMARY outcome

Timeframe: Week 12

Population: Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure.

Participants scored their degree of comfort with their assigned study drug on a 4-point scale (0-3 units) within 5 minutes after instillation of study drug. Comfort grade 0 indicated comfortable, discomfort absent; 1 indicated generally comfortable, mild discomfort; 2 indicated some discomfort but tolerable, moderate discomfort; 3 indicated severely uncomfortable or intolerable. The mean global ocular comfort grade was reported.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=31 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=34 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Mean Grade for Participant-Reported Post-Dosing Ocular Comfort Values	0.5 units on a scale Standard Deviation 0.63	0.6 units on a scale Standard Deviation 0.92	0.5 units on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Light sensitivity: Baseline	1.5 units on a scale Standard Deviation 0.97	1.5 units on a scale Standard Deviation 1.11	1.4 units on a scale Standard Deviation 0.99
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Light sensitivity: Change at Week 12	-0.2 units on a scale Standard Deviation 1.17	-0.1 units on a scale Standard Deviation 1.14	-0.2 units on a scale Standard Deviation 1.36
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Gritty feel: Baseline	1.5 units on a scale Standard Deviation 0.97	1.4 units on a scale Standard Deviation 1.03	1.2 units on a scale Standard Deviation 0.80
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Gritty feel: Change at Week 12	-0.5 units on a scale Standard Deviation 1.09	-0.4 units on a scale Standard Deviation 1.14	-0.2 units on a scale Standard Deviation 1.10
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Painful or sore eyes: Baseline	1.0 units on a scale Standard Deviation 0.81	0.8 units on a scale Standard Deviation 0.77	0.8 units on a scale Standard Deviation 0.87
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Painful or sore eyes: Change at Week 12	-0.2 units on a scale Standard Deviation 1.15	-0.3 units on a scale Standard Deviation 0.83	-0.2 units on a scale Standard Deviation 0.71
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Blurred vision: Baseline	0.9 units on a scale Standard Deviation 0.79	0.7 units on a scale Standard Deviation 0.79	0.9 units on a scale Standard Deviation 0.83
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Blurred vision: Change at Week 12	-0.2 units on a scale Standard Deviation 0.88	-0.1 units on a scale Standard Deviation 0.91	-0.1 units on a scale Standard Deviation 0.89
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Poor vision: Baseline	0.8 units on a scale Standard Deviation 0.77	0.7 units on a scale Standard Deviation 0.79	0.5 units on a scale Standard Deviation 0.71
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Poor vision: Change at Week 12	-0.1 units on a scale Standard Deviation 0.94	0.1 units on a scale Standard Deviation 0.82	0.1 units on a scale Standard Deviation 0.93
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Problem in reading: Baseline	0.7 units on a scale Standard Deviation 0.72	0.8 units on a scale Standard Deviation 0.75	0.9 units on a scale Standard Deviation 0.77
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Problem in reading: Change at Week 12	0.0 units on a scale Standard Deviation 0.68	0.0 units on a scale Standard Deviation 0.82	-0.2 units on a scale Standard Deviation 1.07
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Problem in driving at night: Baseline	0.9 units on a scale Standard Deviation 0.84	1.3 units on a scale Standard Deviation 1.01	1.1 units on a scale Standard Deviation 1.07
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Problem in driving at night: Change at Week 12	-0.2 units on a scale Standard Deviation 1.11	0.0 units on a scale Standard Deviation 1.22	-0.2 units on a scale Standard Deviation 1.05
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Problem in working with computer: Baseline	0.9 units on a scale Standard Deviation 0.81	1.0 units on a scale Standard Deviation 1.02	0.9 units on a scale Standard Deviation 0.80
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Problem in working with computer:Change at Week12	-0.1 units on a scale Standard Deviation 0.90	-0.2 units on a scale Standard Deviation 0.83	-0.2 units on a scale Standard Deviation 0.83
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Problem in watching TV: Baseline	0.9 units on a scale Standard Deviation 0.60	1.0 units on a scale Standard Deviation 0.94	0.8 units on a scale Standard Deviation 0.78
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Problem in watching TV: Change at Week 12	-0.4 units on a scale Standard Deviation 0.75	-0.1 units on a scale Standard Deviation 1.13	0.1 units on a scale Standard Deviation 0.91
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Uncomfortable in windy conditions: Baseline	1.3 units on a scale Standard Deviation 1.04	1.5 units on a scale Standard Deviation 1.16	1.4 units on a scale Standard Deviation 1.00
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Uncomfortable in windy condition:Change at Week12	-0.2 units on a scale Standard Deviation 1.12	0.0 units on a scale Standard Deviation 1.18	0.0 units on a scale Standard Deviation 1.33
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Uncomfortable in low humidity: Baseline	1.5 units on a scale Standard Deviation 1.12	1.4 units on a scale Standard Deviation 1.08	1.3 units on a scale Standard Deviation 0.88
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Uncomfortable in low humidity: Change at Week 12	-0.7 units on a scale Standard Deviation 1.21	0.2 units on a scale Standard Deviation 1.00	0.0 units on a scale Standard Deviation 1.32
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Uncomfortable in air conditioning: Baseline	1.5 units on a scale Standard Deviation 0.97	1.5 units on a scale Standard Deviation 1.07	1.6 units on a scale Standard Deviation 0.87
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Uncomfortable in air conditioning:Change at Week12	-0.3 units on a scale Standard Deviation 1.11	-0.3 units on a scale Standard Deviation 1.43	-0.8 units on a scale Standard Deviation 1.34
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Total OSDI score: Baseline	27.9 units on a scale Standard Deviation 8.41	27.8 units on a scale Standard Deviation 9.18	26.5 units on a scale Standard Deviation 8.12
Change From Baseline in Mean OSDI Questionnaire Total Score and Individual Question Scores at Week 12 Total OSDI score: Change at Week 12	-5.6 units on a scale Standard Deviation 14.50	-3.2 units on a scale Standard Deviation 15.05	-4.0 units on a scale Standard Deviation 15.14

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.

Fluorescein Corneal Staining indicates the damage to the corneal epithelium (corneal epitheliopathy). Punctate corneal staining with fluorescein was evaluated and graded according to the NEI grading method. The cornea was divided into 5 regions: central, superior, inferior, nasal and temporal. Each of these 5 regions was graded from scores 0 to 3, where 0 indicated no staining (absent) and 3 maximal staining (severe damage). The total score was the sum of all these regions, ranged from 0 (absence of corneal epitheliopathy) to 15 (severe corneal epitheliopathy).

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean Corneal Total Fluorescein Staining Score for the Study Eye and Averaged for Both Eyes at Week 12 Score for study eye: Baseline	5.6 units on a scale Standard Deviation 1.92	5.7 units on a scale Standard Deviation 2.19	5.5 units on a scale Standard Deviation 1.97
Change From Baseline in Mean Corneal Total Fluorescein Staining Score for the Study Eye and Averaged for Both Eyes at Week 12 Score for study eye: Change at Week 12	-1.3 units on a scale Standard Deviation 2.30	-0.7 units on a scale Standard Deviation 3.01	-1.6 units on a scale Standard Deviation 2.46
Change From Baseline in Mean Corneal Total Fluorescein Staining Score for the Study Eye and Averaged for Both Eyes at Week 12 Score for both eyes: Baseline	5.02 units on a scale Standard Deviation 1.637	5.22 units on a scale Standard Deviation 1.955	5.08 units on a scale Standard Deviation 1.896
Change From Baseline in Mean Corneal Total Fluorescein Staining Score for the Study Eye and Averaged for Both Eyes at Week 12 Score for both eyes: Change at Week 12	-0.66 units on a scale Standard Deviation 1.809	-0.69 units on a scale Standard Deviation 2.400	-1.17 units on a scale Standard Deviation 2.207

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.

Participants eligible for enrollment rated the severity of dry eye symptoms at Baseline (Day 0) on a 5-point grading scale (ranged from 0 \[no problem\] to 4 \[continuous or severe discomfort; intolerable\]) for each of 8 symptoms in the following symptom list prior to enrollment and then selected their most bothersome symptom: Photophobia, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, eye discomfort, burning or stinging, or photopsia (sensation of light or light flashes). Participants subsequently rated their dry eye symptom severity on the same 5-point grading scale at Week 2-Week 12 for study eye for the worst symptom identified at Baseline.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Burning or stinging: Baseline	1.2 units on a scale Standard Deviation 1.12	1.2 units on a scale Standard Deviation 1.28	1.0 units on a scale Standard Deviation 1.24
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Burning or stinging: Change at Week 12	-0.5 units on a scale Standard Deviation 1.23	-0.6 units on a scale Standard Deviation 1.26	-0.3 units on a scale Standard Deviation 1.35
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Eye discomfort: Baseline	1.5 units on a scale Standard Deviation 1.03	1.8 units on a scale Standard Deviation 1.17	1.8 units on a scale Standard Deviation 1.06
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Eye discomfort: Change at Week 12	-0.5 units on a scale Standard Deviation 1.26	-0.9 units on a scale Standard Deviation 1.06	-1.1 units on a scale Standard Deviation 0.97
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Foreign body sensation: Baseline	0.9 units on a scale Standard Deviation 0.98	1.3 units on a scale Standard Deviation 1.19	1.0 units on a scale Standard Deviation 0.95
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Foreign body sensation: Change at Week 12	-0.3 units on a scale Standard Deviation 1.40	-0.6 units on a scale Standard Deviation 1.27	-0.5 units on a scale Standard Deviation 1.03
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Grittiness or sandiness: Baseline	1.5 units on a scale Standard Deviation 1.15	1.6 units on a scale Standard Deviation 1.16	1.3 units on a scale Standard Deviation 1.05
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Grittiness or sandiness: Change at Week 12	-0.5 units on a scale Standard Deviation 1.18	-0.8 units on a scale Standard Deviation 1.10	-0.5 units on a scale Standard Deviation 1.39
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Haziness or blurriness: Baseline	1.2 units on a scale Standard Deviation 0.87	1.2 units on a scale Standard Deviation 1.12	1.3 units on a scale Standard Deviation 1.18
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Haziness or blurriness: Change at Week 12	-0.4 units on a scale Standard Deviation 0.88	-0.3 units on a scale Standard Deviation 1.24	-0.6 units on a scale Standard Deviation 1.03
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Itchiness or scratchiness: Baseline	1.4 units on a scale Standard Deviation 0.99	1.5 units on a scale Standard Deviation 1.23	1.5 units on a scale Standard Deviation 0.97
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Itchiness or scratchiness: Change at Week 12	-0.4 units on a scale Standard Deviation 1.28	-0.6 units on a scale Standard Deviation 1.17	-0.5 units on a scale Standard Deviation 1.12
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Photophobia: Baseline	1.3 units on a scale Standard Deviation 1.21	1.4 units on a scale Standard Deviation 1.23	1.5 units on a scale Standard Deviation 1.09
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Photophobia: Change at Week 12	-0.2 units on a scale Standard Deviation 1.05	-0.2 units on a scale Standard Deviation 1.21	-0.5 units on a scale Standard Deviation 1.03
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Photopsia: Baseline	0.2 units on a scale Standard Deviation 0.46	0.3 units on a scale Standard Deviation 0.51	0.3 units on a scale Standard Deviation 0.85
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Photopsia: Change at Week 12	0.0 units on a scale Standard Deviation 0.66	-0.1 units on a scale Standard Deviation 0.56	-0.1 units on a scale Standard Deviation 1.10
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Worst dry eye symptom: Baseline	2.2 units on a scale Standard Deviation 0.96	2.6 units on a scale Standard Deviation 0.94	2.5 units on a scale Standard Deviation 0.94
Change From Baseline in Mean Value of Participant Worst Eye Score for Each Symptom (Including the Pre-Specified Worst Symptom) in the List of Possible Worst Symptoms at Week 12 Worst dry eye symptom: Change at Week 12	-0.8 units on a scale Standard Deviation 1.34	-1.3 units on a scale Standard Deviation 1.23	-1.5 units on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.

LG staining is useful for monitoring evidence of eye dryness in conjunctival tissue. Scoring of conjunctival staining was done using Oxford conjunctival grading scale. The investigator instilled an ophthalmic dye (LG stain) on the eye and rated staining in 2 areas (nasal and temporal conjunctiva). Staining was rated on a 6-point scale from 0 (absent) to 5 (severe). The total score ranged from 0 (improvement; no conjunctival damage) to 12 (worsening; severe conjunctival damage).

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean Total Combined Lissamine Green (LG) Staining (Nasal Plus Temporal Conjunctival) Score for the Study Eye and Averaged for Both Eyes at Week 12 Score for study eye: Baseline	8.5 units on a scale Standard Deviation 5.10	9.2 units on a scale Standard Deviation 4.68	7.7 units on a scale Standard Deviation 4.50
Change From Baseline in Mean Total Combined Lissamine Green (LG) Staining (Nasal Plus Temporal Conjunctival) Score for the Study Eye and Averaged for Both Eyes at Week 12 Score for study eye: Change at Week 12	-0.9 units on a scale Standard Deviation 4.31	-1.8 units on a scale Standard Deviation 5.45	-1.2 units on a scale Standard Deviation 4.32
Change From Baseline in Mean Total Combined Lissamine Green (LG) Staining (Nasal Plus Temporal Conjunctival) Score for the Study Eye and Averaged for Both Eyes at Week 12 Score for both eyes: Baseline	8.37 units on a scale Standard Deviation 5.045	9.06 units on a scale Standard Deviation 4.107	7.35 units on a scale Standard Deviation 4.542
Change From Baseline in Mean Total Combined Lissamine Green (LG) Staining (Nasal Plus Temporal Conjunctival) Score for the Study Eye and Averaged for Both Eyes at Week 12 Score for both eyes: Change at Week 12	-0.98 units on a scale Standard Deviation 4.195	-1.82 units on a scale Standard Deviation 4.927	-0.75 units on a scale Standard Deviation 4.811

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable at specified timepoints.

Tear osmolarity was measured with the TearLab Osmolarity System. The TearLab instrument measures the impedance of 50 nanoliters (nL) tear samples taken with a disposable lab-on-a-chip device. Tear samples from enrolled participants were taken at Weeks 2, 4, and 12 from each eye in duplicate with a tear sampler according to the manufacturer's instructions, and the tear osmolarity for each sample was read with the TearLab instrument. Osmolarity values were provided by the TearLab instrument in 3-digit units of milliosmoles (mOsm). Change from mean baseline values for all participants within a treatment group was calculated using a participant's worst eye value at Week 12.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean Tear Osmolarity of Participant Worst Eye Value at Week 12 Baseline	312.1 mOsm Standard Deviation 11.48	307.4 mOsm Standard Deviation 8.91	311.6 mOsm Standard Deviation 17.11
Change From Baseline in Mean Tear Osmolarity of Participant Worst Eye Value at Week 12 Change at Week 12	0.7 mOsm Standard Deviation 16.67	4.3 mOsm Standard Deviation 9.88	-1.5 mOsm Standard Deviation 17.33

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable at specified timepoints.

Tear osmolarity was measured with the TearLab Osmolarity System. The TearLab instrument measures the impedance of 50 nL tear samples taken with a disposable lab-on-a-chip device. Tear samples from enrolled participants were taken at Weeks 2, 4, and 12 from each eye in duplicate with a tear sampler according to the manufacturer's instructions, and the tear osmolarity for each sample was read with the TearLab instrument. Osmolarity values were provided by the TearLab instrument in 3-digit units of mOsm. Change from mean baseline values for all participants within a treatment group was calculated for the difference between average values between 2 eyes at Week 12.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean Tear Osmolarity Between Two Eyes of Participant at Week 12 Baseline	7.9 mOsm Standard Error 5.72	5.4 mOsm Standard Error 4.62	7.2 mOsm Standard Error 10.44
Change From Baseline in Mean Tear Osmolarity Between Two Eyes of Participant at Week 12 Change at Week 12	0.6 mOsm Standard Error 9.70	2.9 mOsm Standard Error 6.62	-0.3 mOsm Standard Error 11.52

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.

An ocular comfort assessment questionnaire was administered at weeks 2, 4, and 12 to participants. The assessment of the degree of dry eye discomfort experienced by the participant was conducted using an adapted and validated 12-item ocular comfort questionnaire ( to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching) based upon the ocular comfort index of Johnson and Murphy. Each item (question) was graded from 0 to 4, where 0 = Not at all, 1 = Seldom; perceptible but not intense, 2 = Sometimes; intermittent with easily tolerable intensity, 3 = Frequently; often but with tolerable intensity, 4 = Constantly; constant or intolerable intensity. Total score was calculated and normalized to a score of 0 (no discomfort)-100 (more ocular discomfort) by the formula: Normalized comfort grade = (\[Total Comfort Grade\] \* 100)/48.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Dryness: Change at Week 12	-0.4 units on a scale Standard Deviation 0.92	-0.1 units on a scale Standard Deviation 0.99	-0.4 units on a scale Standard Deviation 0.87
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Dryness intensity: Baseline	2.2 units on a scale Standard Deviation 0.93	2.1 units on a scale Standard Deviation 0.90	2.2 units on a scale Standard Deviation 0.92
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Dryness intensity: Change at Week 12	-0.5 units on a scale Standard Deviation 0.93	-0.3 units on a scale Standard Deviation 1.06	-0.6 units on a scale Standard Deviation 1.08
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Grittiness: Baseline	1.5 units on a scale Standard Deviation 0.90	1.7 units on a scale Standard Deviation 1.09	1.4 units on a scale Standard Deviation 0.97
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Grittiness: Change at Week 12	-0.4 units on a scale Standard Deviation 0.97	-0.6 units on a scale Standard Deviation 0.95	-0.6 units on a scale Standard Deviation 1.06
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Grittiness intensity: Baseline	1.6 units on a scale Standard Deviation 1.06	1.6 units on a scale Standard Deviation 0.93	1.3 units on a scale Standard Deviation 0.98
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Grittiness intensity: Change at Week 12	-0.5 units on a scale Standard Deviation 0.96	-0.6 units on a scale Standard Deviation 0.96	-0.5 units on a scale Standard Deviation 1.03
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Stinging: Baseline	1.3 units on a scale Standard Deviation 1.07	1.2 units on a scale Standard Deviation 1.15	1.0 units on a scale Standard Deviation 0.79
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Pain intensity: Change at Week 12	-0.1 units on a scale Standard Deviation 1.02	-0.3 units on a scale Standard Deviation 1.07	-0.3 units on a scale Standard Deviation 0.74
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Stinging: Change at Week 12	-0.2 units on a scale Standard Deviation 1.17	-0.4 units on a scale Standard Deviation 1.13	-0.1 units on a scale Standard Deviation 1.38
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Itch: Baseline	1.5 units on a scale Standard Deviation 1.03	1.6 units on a scale Standard Deviation 1.16	1.2 units on a scale Standard Deviation 0.99
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Stinging intensity: Baseline	1.2 units on a scale Standard Deviation 1.06	1.3 units on a scale Standard Deviation 1.16	1.0 units on a scale Standard Deviation 0.85
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Stinging intensity: Change at Week 12	-0.2 units on a scale Standard Deviation 0.93	-0.4 units on a scale Standard Deviation 1.11	-0.1 units on a scale Standard Deviation 1.23
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Tiredness: Baseline	1.8 units on a scale Standard Deviation 1.01	1.6 units on a scale Standard Deviation 0.93	1.9 units on a scale Standard Deviation 1.02
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Tiredness: Change at Week 12	-0.4 units on a scale Standard Deviation 1.11	-0.2 units on a scale Standard Deviation 0.77	-0.4 units on a scale Standard Deviation 0.83
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Tiredness intensity: Baseline	1.7 units on a scale Standard Deviation 1.02	1.6 units on a scale Standard Deviation 1.02	1.8 units on a scale Standard Deviation 1.00
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Tiredness intensity: Change at Week 12	-0.3 units on a scale Standard Deviation 1.03	-0.2 units on a scale Standard Deviation 0.90	-0.4 units on a scale Standard Deviation 0.70
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Pain: Baseline	0.9 units on a scale Standard Deviation 0.89	0.8 units on a scale Standard Deviation 0.81	0.7 units on a scale Standard Deviation 0.69
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Pain: Change at Week 12	-0.2 units on a scale Standard Deviation 0.92	-0.2 units on a scale Standard Deviation 0.96	-0.2 units on a scale Standard Deviation 0.76
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Pain intensity: Baseline	0.9 units on a scale Standard Deviation 0.98	0.8 units on a scale Standard Deviation 0.97	0.8 units on a scale Standard Deviation 0.88
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Itch: Change at Week 12	-0.2 units on a scale Standard Deviation 1.34	-0.7 units on a scale Standard Deviation 1.32	-0.2 units on a scale Standard Deviation 1.07
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Dryness: Baseline	2.3 units on a scale Standard Deviation 0.85	2.2 units on a scale Standard Deviation 0.81	2.2 units on a scale Standard Deviation 0.93
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Itch intensity: Baseline	1.5 units on a scale Standard Deviation 1.03	1.5 units on a scale Standard Deviation 1.16	1.2 units on a scale Standard Deviation 1.09
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Itch intensity: Change at Week 12	-0.2 units on a scale Standard Deviation 1.19	-0.7 units on a scale Standard Deviation 1.22	-0.3 units on a scale Standard Deviation 1.10
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Total comfort score: Baseline	38.4 units on a scale Standard Deviation 16.39	37.8 units on a scale Standard Deviation 16.99	34.8 units on a scale Standard Deviation 14.06
Change From Baseline in Mean Eye Comfort Index Questionnaire Total Score and Individual Question Scores at Week 12 Total comfort score: Change at Week 12	-7.2 units on a scale Standard Deviation 17.16	-10.0 units on a scale Standard Deviation 16.35	-8.6 units on a scale Standard Deviation 14.48

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.

The 5-item Dry Eye Questionnaire (DEQ-5) is a validated questionnaire for discriminating self-assessed severity of dry eye diagnoses. The participants rated the frequency on a scale of 0 (never) to 4 (constant) with which they have experienced 3 symptoms (watery eyes, discomfort and dryness). The participant was also asked to rate the increase in intensity of discomfort and dryness throughout the day on a scale of 0 (never have it) to 5 (very intense). Participant rated the overall severity of dry eye symptoms on a scale of 0 (no problem) to 4 (intolerable; unable to perform my daily tasks). Total DEQ-5 score was the sum of scores for frequency and intensity of dryness and discomfort plus frequency of watery eyes. A DEQ-5 total score \>6 was indicative of DED and a score \>12 is indicative of Sjögren's syndrome.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Discomfort frequency: Baseline	2.2 units on a scale Standard Deviation 0.81	2.1 units on a scale Standard Deviation 0.67	2.1 units on a scale Standard Deviation 0.82
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Discomfort frequency: Change at Week 12	-0.4 units on a scale Standard Deviation 0.67	-0.2 units on a scale Standard Deviation 0.97	-0.3 units on a scale Standard Deviation 0.94
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Discomfort intensity: Baseline	2.4 units on a scale Standard Deviation 1.14	2.5 units on a scale Standard Deviation 1.03	2.4 units on a scale Standard Deviation 1.22
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Discomfort intensity: Change at Week 12	-0.4 units on a scale Standard Deviation 1.20	-0.5 units on a scale Standard Deviation 0.85	-0.4 units on a scale Standard Deviation 1.11
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Dryness frequency: Baseline	2.4 units on a scale Standard Deviation 0.79	2.1 units on a scale Standard Deviation 0.82	2.4 units on a scale Standard Deviation 1.00
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Dryness frequency: Change at Week 12	-0.6 units on a scale Standard Deviation 0.80	-0.1 units on a scale Standard Deviation 0.83	-0.6 units on a scale Standard Deviation 1.00
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Dryness intensity: Baseline	2.4 units on a scale Standard Deviation 1.15	2.8 units on a scale Standard Deviation 1.08	2.3 units on a scale Standard Deviation 1.27
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Dryness intensity: Change at Week 12	-0.2 units on a scale Standard Deviation 1.31	-0.7 units on a scale Standard Deviation 0.83	-0.4 units on a scale Standard Deviation 1.32
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Watery eyes frequency: Baseline	1.5 units on a scale Standard Deviation 1.00	1.3 units on a scale Standard Deviation 1.03	1.3 units on a scale Standard Deviation 1.16
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Watery eyes frequency: Change at Week 12	-0.4 units on a scale Standard Deviation 1.14	-0.4 units on a scale Standard Deviation 0.77	0.0 units on a scale Standard Deviation 1.37
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Overall severity: Baseline	1.9 units on a scale Standard Deviation 0.77	1.8 units on a scale Standard Deviation 0.82	1.8 units on a scale Standard Deviation 0.79
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Overall severity: Change at Week 12	-0.6 units on a scale Standard Deviation 0.92	-0.4 units on a scale Standard Deviation 0.97	-0.5 units on a scale Standard Deviation 0.71
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Total score: Baseline	11.0 units on a scale Standard Deviation 3.60	10.8 units on a scale Standard Deviation 3.38	10.6 units on a scale Standard Deviation 4.55
Change From Baseline in Mean Eye Dryness Questionnaire Total and Individual Question Scores at Week 12 Total score: Change at Week 12	-2.0 units on a scale Standard Deviation 3.52	-2.0 units on a scale Standard Deviation 2.81	-1.6 units on a scale Standard Deviation 4.08

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.

The TFBUT was defined as the interval between the last complete blink and the first appearance of dark zones or spots, or disruption in the tear film. Tear film breakup time is a measure of the stability of the tear film protecting the cornea and bulbar conjunctiva. 5 microliters (μL) of fluorescein solution was instilled in the participant's eye, after which the participant blinked several times, then kept the eye open. The cornea was visualized through the slit lamp using appropriate barrier filters for the white light source. TFBUT was counted using a stopwatch. Three consecutive measurements were taken and averaged for actual TFBUT. TFBUT at Baseline (Day 0) was subtracted from TFBUT at Week 12 (Day 84) and reported as change. A higher number represented a lengthening in the TFBUT. A longer TFBUT indicated a more stable tear film.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean Tear Film Breakup Time (TFBUT) (by Fluorescein Staining) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 Study eye: Baseline	2.87 seconds Standard Deviation 1.715	3.23 seconds Standard Deviation 1.739	3.09 seconds Standard Deviation 1.546
Change From Baseline in Mean Tear Film Breakup Time (TFBUT) (by Fluorescein Staining) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 Study eye: Change at Week 12	0.25 seconds Standard Deviation 2.106	0.32 seconds Standard Deviation 2.038	0.16 seconds Standard Deviation 1.807
Change From Baseline in Mean Tear Film Breakup Time (TFBUT) (by Fluorescein Staining) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 Both eyes: Baseline	3.01 seconds Standard Deviation 2.042	3.28 seconds Standard Deviation 1.902	3.45 seconds Standard Deviation 2.371
Change From Baseline in Mean Tear Film Breakup Time (TFBUT) (by Fluorescein Staining) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 Both eyes: Change at Week 12	0.17 seconds Standard Deviation 2.019	0.57 seconds Standard Deviation 2.305	-0.17 seconds Standard Deviation 2.286

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.

The tear film breakup time was defined as the interval between the last complete blink and the first appearance of dark zones or spots, or disruption in the tear film. Tear film examination using any non-invasive method analyzes optical reflections from the cornea. Reflections that become distorted are characteristic of tear film breakup. Circular images were projected onto the corneal surface using an Oculus Keratograph 5M instrument, and the tear film reflection was observed on a computer. NIKBUT (initial break-up time \[NIKBUTi\] and average break-up time \[NIKBUTav\]) were determined and recorded for each eye in duplicate after participant blink 2 times. NIKBUT at Baseline (Day 0) was subtracted from NIKBUT at Week 12 (Day 84) and reported as change. A higher number represented a lengthening in the NIKBUT. A longer NIKBUT indicated a more stable tear film.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 NIKBUTi for study eye: Baseline	6.49 seconds Standard Deviation 1.349	8.11 seconds Standard Deviation 3.531	7.18 seconds Standard Deviation 4.867
Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 NIKBUTi for study eye: Change at Week 12	0.59 seconds Standard Deviation 3.826	1.09 seconds Standard Deviation 5.833	0.31 seconds Standard Deviation 6.356
Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 NIKBUTi for both eyes: Baseline	6.92 seconds Standard Deviation 2.175	8.22 seconds Standard Deviation 4.240	7.60 seconds Standard Deviation 4.896
Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 NIKBUTi for both eyes: Change at Wee 12	-0.14 seconds Standard Deviation 2.774	0.17 seconds Standard Deviation 3.511	-1.08 seconds Standard Deviation 4.770
Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 NIKBUTav for study eye: Baseline	9.57 seconds Standard Deviation 3.018	11.20 seconds Standard Deviation 3.164	9.07 seconds Standard Deviation 5.595
Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 NIKBUTav for study eye: Change at Week 12	-0.01 seconds Standard Deviation 2.806	1.55 seconds Standard Deviation 5.453	1.26 seconds Standard Deviation 5.636
Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 NIKBUTav for both eyes: Baseline	9.21 seconds Standard Deviation 3.253	10.99 seconds Standard Deviation 3.969	9.98 seconds Standard Deviation 5.744
Change From Baseline in Mean Non-Invasive Keratographic Tear Film Breakup Time (NIKBUT) of the Study Eye and Averaged for Both Eyes of a Participant at Week 12 NIKBUTav for both eyes: Change at Week 12	-0.04 seconds Standard Deviation 1.882	1.32 seconds Standard Deviation 3.985	0.04 seconds Standard Deviation 5.117

SECONDARY outcome

Timeframe: Baseline, Week 13

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.

Schirmer's test measures the aqueous component of tear secretion. The Schirmer's test (anesthetized) is a measure of the tonic secretion of the aqueous component of tears. A Schirmer's test (with anaesthesia) was performed for both eyes of a participant using Schirmer's test strips. After instillation of an ophthalmic anaesthetic, Schirmer's test strips for each eye were left in place for 5 minutes with participant eyelids closed. After 5 minutes, the Schirmer's test strips were removed with forceps and the distance to where each strip was wetted was recorded in millimeters (mm). Lesser wetting of strips (low levels of tear production) were associated with dry eye.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Mean Anesthetized Schirmer's Test Values (Distance of Strips Wetting) in the Study Eye and Averaged for Both Eyes of a Participant at Week 13 Wetting distance for Study eye: Baseline	6.1 mm Standard Deviation 1.89	6.6 mm Standard Deviation 2.18	6.6 mm Standard Deviation 2.08
Change From Baseline in Mean Anesthetized Schirmer's Test Values (Distance of Strips Wetting) in the Study Eye and Averaged for Both Eyes of a Participant at Week 13 Wetting distance for Study eye: Change at Week 13	2.5 mm Standard Deviation 6.16	1.7 mm Standard Deviation 6.59	2.5 mm Standard Deviation 5.55
Change From Baseline in Mean Anesthetized Schirmer's Test Values (Distance of Strips Wetting) in the Study Eye and Averaged for Both Eyes of a Participant at Week 13 Wetting distance for both eyes: Change at Week 13	2.17 mm Standard Deviation 5.72	1.39 mm Standard Deviation 5.61	2.59 mm Standard Deviation 5.29
Change From Baseline in Mean Anesthetized Schirmer's Test Values (Distance of Strips Wetting) in the Study Eye and Averaged for Both Eyes of a Participant at Week 13 Wetting distance for both eyes: Baseline	6.66 mm Standard Deviation 1.76	6.78 mm Standard Deviation 2.01	6.76 mm Standard Deviation 1.90

SECONDARY outcome

Timeframe: Baseline up to Week 12

Population: ITT population included all randomized participants.

Amount of averaged daily soothe lubricant eye drops (Bausch + Lomb) used was reported.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Averaged Daily Soothe Lubricant Eye Drops Usage	2.07 drops/day Standard Deviation 1.013	1.79 drops/day Standard Deviation 1.073	2.04 drops/day Standard Deviation 1.075

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for specified categories; that is, participants who had investigator global improvement assessment or participant-reported global improvement assessments.

Participants and investigators independently rated the overall change from baseline in dry eye conditions for each participant on a 7-point Likert scale at Week 12. The scale ranged from +3 to -3, where +3 = Substantial improvement in dry eye; little or no awareness of dry eye, +2 = Some improvement in dry eye, +1 = Little improvement in dry eye, 0 = No improvement in dry eye, -1 = Slight worsening of dry eye, -2 = Some worsening of dry eye, and -3 = Substantial worsening of dry eye.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=31 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=34 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Participant-reported: · -3	1 Participants	0 Participants	0 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Investigator-reported: · +3	0 Participants	2 Participants	3 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Investigator-reported: · +2	7 Participants	11 Participants	10 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Investigator-reported: · +1	16 Participants	12 Participants	14 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Investigator-reported: · 0	5 Participants	8 Participants	4 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Investigator-reported: · -1	2 Participants	1 Participants	1 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Investigator-reported: · -2	1 Participants	0 Participants	1 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Investigator-reported: · -3	0 Participants	0 Participants	0 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Participant-reported: · +3	4 Participants	6 Participants	9 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Participant-reported: · +2	10 Participants	15 Participants	14 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Participant-reported: · +1	8 Participants	7 Participants	7 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Participant-reported: · 0	6 Participants	5 Participants	2 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Participant-reported: · -1	2 Participants	1 Participants	1 Participants
Number of Participants With Overall Change From Baseline in Dry Symptoms at Week 12 as Assessed Independently by Investigators and Participants Participant-reported: · -2	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.

The Investigator subjectively rated the degree of eye redness on a 4-point (0-3) grading scale prior to any objective grading of eye redness for a participant, where score 0 = none absent; no redness present in the white of the eyes, 1 = mild, slightly dilated blood vessels seen in some portion of the white of the eyes; the color of vessels was typically pink, 2 = moderate more apparent dilation of blood vessels in the white of the eyes; vessel color was more intense (redder) and involves the majority of the vessel bed, 3 = severe numerous obvious dilated blood vessels throughout the white of the eyes; the vessel color was deep red.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Ocular Redness Score for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Redness of study eye: Baseline	1.0 units on a scale Standard Deviation 0.79	1.0 units on a scale Standard Deviation 0.70	1.0 units on a scale Standard Deviation 0.68
Change From Baseline in Ocular Redness Score for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Redness of study eye: Change at Week 12	-0.1 units on a scale Standard Deviation 0.60	-0.2 units on a scale Standard Deviation 0.69	-0.1 units on a scale Standard Deviation 0.66
Change From Baseline in Ocular Redness Score for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Redness of both eyes: Baseline	1.00 units on a scale Standard Deviation 0.760	0.97 units on a scale Standard Deviation 0.696	1.06 units on a scale Standard Deviation 0.726
Change From Baseline in Ocular Redness Score for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Redness of both eyes: Change at Week 12	-0.10 units on a scale Standard Deviation 0.583	-0.21 units on a scale Standard Deviation 0.698	-0.12 units on a scale Standard Deviation 0.625

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: ITT population included all randomized participants. Here, 'Number analyzed' signifies participants evaluable for specified categories.

The objective redness scoring assessment was conducted by automated means using an Oculus Keratograph 5M. Duplicate digital photographs of bulbar and limbal conjunctiva were taken with the Oculus Keratograph 5M instrument for each eye of a participant and the images were analyzed using R-Scan classification software to numerically rate the severity of ocular redness (bulbar and limbal redness) on a 4-point (0-3) grading scale, where score 0 = none absent; no redness present in the white of the eyes, 1 = mild, slightly dilated blood vessels seen in some portion of white of the eyes; color of vessels was typically pink, 2 = moderate more apparent dilation of blood vessels in the white of the eyes; vessel color was more intense (redder) and involves the majority of the vessel bed, 3 = severe numerous obvious dilated blood vessels throughout the white of the eyes; the vessel color was deep red. Keratograph 5M ocular redness grading results were averaged for each eye and for both eyes.

Outcome measures

Outcome measures
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 Participants Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 Participants Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 Participants Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Limbal study eye redness: Baseline	0.608 units on a scale Standard Deviation 0.1919	0.615 units on a scale Standard Deviation 0.2379	0.625 units on a scale Standard Deviation 0.3917
Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Limbal study eye redness: Change at Week 12	0.039 units on a scale Standard Deviation 0.0830	0.015 units on a scale Standard Deviation 0.1760	0.004 units on a scale Standard Deviation 0.2171
Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Limbal both eyes redness: Baseline	0.643 units on a scale Standard Deviation 0.2295	0.550 units on a scale Standard Deviation 0.1915	0.734 units on a scale Standard Deviation 0.3225
Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Limbal both eyes redness: Change at Week 12	0.038 units on a scale Standard Deviation 0.1413	0.031 units on a scale Standard Deviation 0.1473	-0.050 units on a scale Standard Deviation 0.1340
Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Bulbar study eye redness: Baseline	0.975 units on a scale Standard Deviation 0.3482	1.062 units on a scale Standard Deviation 0.2807	0.965 units on a scale Standard Deviation 0.3132
Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Bulbar study eye redness: Change at Week 12	0.139 units on a scale Standard Deviation 0.2118	-0.069 units on a scale Standard Deviation 0.3146	-0.050 units on a scale Standard Deviation 0.3162
Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Bulbar both eyes redness: Baseline	0.995 units on a scale Standard Deviation 0.3310	0.992 units on a scale Standard Deviation 0.2120	0.994 units on a scale Standard Deviation 0.2354
Change From Baseline in Non-Invasive Keratographic Limbal and Bulbar Ocular Redness Scores for Study Eye and Averaged for Both Eyes at Week 12, as Assessed by Investigator Bulbar both eyes redness: Change at Week 12	0.064 units on a scale Standard Deviation 0.1949	-0.038 units on a scale Standard Deviation 0.2444	-0.089 units on a scale Standard Deviation 0.1939

Adverse Events

Lotemax Gel 0.5% and Restasis 0.05%

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Lotemax Gel 0.5%

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Restasis 0.05%

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lotemax Gel 0.5% and Restasis 0.05% n=33 participants at risk Participants administered lotemax gel 0.5% BID OU for 2 weeks, then administered both lotemax gel 0.5% and restasis emulsion 0.05% BID OU for 2 weeks, then administered restasis emulsion 0.05% BID OU for 8 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Lotemax Gel 0.5% n=36 participants at risk Participants administered lotemax gel 0.5% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).	Restasis 0.05% n=33 participants at risk Participants administered restasis emulsion 0.05% BID OU for 12 weeks. Participants also received preservative-free Soothe Lubricant Eye Drops as needed (up to 4 times per day).
Eye disorders Eye Irritation	9.1% 3/33 • Baseline up to Week 13 Safety population included all randomized participants who received at least 1 dose of study drug.	5.6% 2/36 • Baseline up to Week 13 Safety population included all randomized participants who received at least 1 dose of study drug.	6.1% 2/33 • Baseline up to Week 13 Safety population included all randomized participants who received at least 1 dose of study drug.
Eye disorders Eye Pruritus	6.1% 2/33 • Baseline up to Week 13 Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/36 • Baseline up to Week 13 Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/33 • Baseline up to Week 13 Safety population included all randomized participants who received at least 1 dose of study drug.
General disorders Instillation Site Pain	6.1% 2/33 • Baseline up to Week 13 Safety population included all randomized participants who received at least 1 dose of study drug.	0.00% 0/36 • Baseline up to Week 13 Safety population included all randomized participants who received at least 1 dose of study drug.	3.0% 1/33 • Baseline up to Week 13 Safety population included all randomized participants who received at least 1 dose of study drug.

Additional Information

Director of Clinical Operations

Bausch & Lomb Incorporated

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Please contact Sponsor directly for additional information.
Publication restrictions are in place

Restriction type: OTHER