Trial Outcomes & Findings for Effect of Cequa™ in Subjects With Dry Eye Disease (NCT NCT04357795)

Results Overview

Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

135 participants

Primary outcome timeframe

Week12

Results posted on

2024-02-06

Participant Flow

Participant milestones

Participant milestones
Measure	CequaTM (Cyclosporine 0.09%) Ophthalmic Solution CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Overall Study STARTED	134
Overall Study COMPLETED	115
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Cequa™ in Subjects With Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CequaTM (Cyclosporine 0.09%) Ophthalmic Solution n=125 Participants CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Age, Continuous	65.5 years n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	107 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week12

Scale for Corneal Staining as defined by the FDA/NEI: 0-4 (0-no staining, 4-severe staining). The higher number indicates more severe. The lower the number indicates less severe staining on the cornea

Outcome measures

Outcome measures
Measure	CequaTM (Cyclosporine 0.09%) Ophthalmic Solution n=125 Participants CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Mean Change in Baseline in Total Corneal Fluoroscein Staining Score	-3.1 score on a scale Standard Deviation 2.88

PRIMARY outcome

Timeframe: Week12

Based on questionnaire asked to subjects (sign and symptoms), modified symptom of dry eye score (range 0 to 100) will be assessed. Increase in score will indicate severity in the symptoms.

Outcome measures

Outcome measures
Measure	CequaTM (Cyclosporine 0.09%) Ophthalmic Solution n=125 Participants CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Change From Baseline in Modified Dry Eye Scoring.	-29.14 score on a scale Standard Deviation 26.220

SECONDARY outcome

Timeframe: Week 12

Based on Investigator's judgement, 6 areas of the conjunctiva will be evaluated in a low to moderate intensity. Scale for Conjunctival Staining defined: 0-6 (0 no staining, 6-severe staining). The higher the number indicates more severe. The lower the number indicates less severe staining on the conjunctival

Outcome measures

Outcome measures
Measure	CequaTM (Cyclosporine 0.09%) Ophthalmic Solution n=124 Participants CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Mean Change in Baseline for Conjunctival Staining Assessment	-2.35 score on a scale Standard Deviation 2.918

SECONDARY outcome

Timeframe: Week 12

Five areas of cornea will be evaluated on a 0 to 4 scale and value from 0 (absent) to 4 (severe) to each section will be allotted based on NEI grading scale

Outcome measures

Outcome measures
Measure	CequaTM (Cyclosporine 0.09%) Ophthalmic Solution n=125 Participants CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Changes From Baseline in Central Corneal Staining Score	-0.5 score on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Week 12

Tear osmolarity of both the eyes will be assessed and score (mOsm/L) will be allotted to each eye. Higher score will indicate severity of the disease (dry eye). Tear osmolarity OU was assessed using the TearLab Osmolarity System Test by collecting nanoliter volumes of tear fluid at each visit from each eyelid margin using the Osmolarity Test Pen and Test Card. Results were interpreted according to the provided instructions and scores (mOsm/L) for each eye were recorded. Normal, mild/moderate, and severe dry eyes had average tear osmolarity values of approximately 302+/-8 mOsm/L, 315+/-10 mOsm/L and 336+/022 mOsm/L, respectively.

Outcome measures

Outcome measures
Measure	CequaTM (Cyclosporine 0.09%) Ophthalmic Solution n=125 Participants CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Mean Change in Baseline for Tear Osmolarity Score for Both Eyes OD- Right eye	-4.0 mOsm/L Standard Deviation 19.44
Mean Change in Baseline for Tear Osmolarity Score for Both Eyes OS- left eye	-11.7 mOsm/L Standard Deviation 18.54

SECONDARY outcome

Timeframe: Week 12

Based on entries in the subject diaries, frequency of artificial tear product use will be assessed. Frequency for artificial tear: This is number of times per day recorded in a daily diary log assessed at baseline and week 12. The higher the number the worse the outcome. The lower the number the better the outcome

Outcome measures

Outcome measures
Measure	CequaTM (Cyclosporine 0.09%) Ophthalmic Solution n=124 Participants CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Mean Change From Baseline in Frequency of Artificial Tear Product Use.	-1.5 times product used/day Standard Deviation 2.39

SECONDARY outcome

Timeframe: Week 12

An unanesthetized Schirmer's test was performed in each eye at least 5 minutes after the lissamine green conjunctival staining to allow for any reflex tearing to subside. At each visit, strips were placed OU at the same time and timed for 5 min. Strips were removed after 5 min and the amount of wetting was recorded in mm and also marked with a line on the strip. The Investigator recorded a score for each eye. A score of greater than 10 mm in 5 minutes is accepted as normal. A score of less than 5 mm in 5 minutes indicates a tear deficiency. A score less than 10 mm in 5 minutes indicates a change from normal in tear production.

Outcome measures

Outcome measures
Measure	CequaTM (Cyclosporine 0.09%) Ophthalmic Solution n=125 Participants CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Schirmer's Test Score	2.4 mm Standard Deviation 8.61

SECONDARY outcome

Timeframe: Week 12

Subjects will be asked, which treatment they prefer for the management of the dry eye (prior treatment or study treatment). Note- For this outcome measure, participants were provided the option to not choose either treatment as the preferred treatment.

Outcome measures

Outcome measures
Measure	CequaTM (Cyclosporine 0.09%) Ophthalmic Solution n=113 Participants CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment. Prefer prior treatment	21.8 percentage of participants
Percentage of Subjects Who Prefer Study Treatments Over Prior Treatment. Prefer study treatment	69.4 percentage of participants

Adverse Events

CequaTM (Cyclosporine 0.09%) Ophthalmic Solution

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CequaTM (Cyclosporine 0.09%) Ophthalmic Solution n=134 participants at risk CequaTM (Cyclosporine 0.09%) ophthalmic solution: One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
General disorders Instillation Site Irritation	12.7% 17/134 • 12 weeks
General disorders Instillation Site Pain	2.2% 3/134 • 12 weeks

Additional Information

Head-Clinical Development

Sun Pharmaceutical Industries Limited

Phone: 2266455645

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place