LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Study Overview
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Brief Summary
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Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.

Detailed Description
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A Phase 3, Multi-Center, Double-Masked, Vehicle Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.

Official Title
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A Phase 3, Multi-Center, Double-Masked, Vehicle-Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, (BID and TID) Versus Vehicle Gel

Conditions
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Cataract, Pain, Ocular Inflammation

Intervention / Treatment
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* Drug: Loteprednol Etabonate Ophthalmic Gel dosed TID
* Drug: Loteprednol Etabonate Ophthalmic Gel dosed BID
* Drug: Vehicle Gel


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Be 18 years or older on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent. Be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide Health Insurance Portability and Accountability Act (HIPAA) authorization. Be willing and able to comply with all treatment and follow-up/study procedures. Be a candidate for routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens [IOL] implantation, not combined with any other surgery). In the Investigator's opinion, have potential postoperative pin-holed Snellen visual acuity (VA) of at least 20/200 in the study eye at Visit 1 (Screening) and at least 20/200 in the fellow eye. Key Exclusion Criteria: Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study. Be a female subject who is pregnant or breastfeeding. Be monocular (fellow eye is nonfunctional or fellow eye's pinhole vision is worse than Snellen 20/200). Have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to Visit 1 (Screening).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loteprednol Etabonate Ophthalmic Gel dosed TID<br>Gel | Drug: Loteprednol Etabonate Ophthalmic Gel dosed TID<br>* Gel<br>* Other names: LE;|
| Experimental: Loteprednol Etabonate Ophthalmic Gel dosed BID<br>Gel | Drug: Loteprednol Etabonate Ophthalmic Gel dosed BID<br>* Gel<br>* Other names: LE;|
| Placebo Comparator: Vehicle Gel<br>Vehicle | Drug: Vehicle Gel<br>* Gel<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8) | Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye. | 8 days | 
| Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8) | Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0. | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit. | Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye. | 14 days | 
| Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Final On-Treatment Visit | Ocular pain, defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching, was assessed and graded by subjects on a 6-point scale: 0 (None), 1 (Minimal), 2 (Mild), 3 (Moderate), 4 (Moderately Severe), and 5 (Severe). Complete Resolution of Ocular Pain was defined as Pain Score = 0. | 14 days | 
| Number of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye at Final On-Treatment Visit | Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). An AC flare score of 0 in the study eye was considered complete resolution. | 14 days | 
| Number of Participants With Complete Resolution of Both Anterior Chamber (AC) Cells and AC Flare in the Study Eye at Final On-Treatment Visit | Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Complete resolution of AC cells was defined as Cell score = 0 in the study eye. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). An AC flare score of 0 in the study eye was considered complete resolution. | 14 days | 
| Change From Baseline in Summed Anterior Chamber (AC) Cell and Flare Scores at Final On-Treatment Visit | Slit lamp examination was performed. White blood cell accumulation in anterior aqueous humor was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0 = no cells seen; Grade 1 = 1 to 5 cells; Grade 2 = 6 to 15 cells; Grade 3 = 16 to 30 cells; Grade 4 = > 30 cells. Flare was evaluated by the Investigator by assessing the scattering of a slit lamp light beam directed into the anterior chamber (Tyndall effect). Flare was graded on a 5-point scale: 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe), and 4 (Very Severe). The combined endpoint was defined as the sum of the scores for AC cells and AC flare. Summed Anterior Chamber (AC) Cell and Flare Scores could range from 0 to 8. | 14 days | 
| Number of Participants With Treatment Failure at Visit 5 (Postoperative Day 8) | A participant was considered a treatment failure at Visit 5 if they started any rescue medication prior to, or on the day of, Visit 5. If a subject did not have a Visit 5, due either to early discontinuation or to a missed visit, then treatment failure at Visit 5 was defined as starting rescue medication prior to, or on, Postoperative Day 8. | 8 days |