Effect of Cequa Treatment on Accuracy of Pre-operative Biometry & Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.

Detailed Description
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Hypothesis: In patients with dry eye, defined as corneal staining and a reduced tear breakup time, the accuracy of pre-operative biometry and corneal surface HOAs will improve significantly after four weeks of Cequa treatment. Primary Outcome Measure: Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery. Secondary Outcome Measures: The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea. The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment. The difference in corneal staining and tear breakup time (TBUT) before and after treatment with Cequa.

Official Title
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Effect of Cequa Treatment on Accuracy of Pre-operative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Cequa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with planned cataract surgery, The presence of central or inferior corneal fluorescein staining defined by the Oxford Scale Reduced tear break up time (TBUT) ≤ 10 seconds. Able to comprehend and sign a statement of informed consent. Willing and able to complete all required postoperative visits. Exclusion Criteria: Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study. Clinically significant ocular trauma. Active ocular Herpes simplex or Herpes Zoster infection Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator. Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye). Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings. Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis. Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis) Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis). Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity). Participation in this trial in the same patient's fellow eye Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cequa Treatment In Cataract Patients with Dry Eye Disease<br>Duration of Study Treatment - 4 weeks All patients will receive cyclosporine ophthalmic solution (0.09%) BID in both eyes for 28 days, 1 drop per dose. Dosing will be BID, both eyes, assuming both eyes will eventually undergo cataract surgery. Otherwise, single eye treatment in the operative eye will be permitted. | Drug: Cequa<br>* The effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery. |  | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea. |  | Four Weeks | 
| The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment. | To compare the difference in Standard Patient of Eye Dryness Questionnaire (SPEED) scores before and after 4 weeks of therapy with Cequa BID among patients with significant dry eye (decreased TBUT or corneal staining) with planned cataract surgery. The SPEED questionnaire gives a score from 0-28 that is the result of 8 items that assess frequency and severity of symptoms. Speed Score Severity rating: 0-4 Mild, 5-7 Moderate, 8+ Severe. | Four Weeks | 
| The difference in corneal staining before and after treatment with Cequa. | The presence of central or inferior corneal fluorescein staining defined by the Oxford Scale. | Four Weeks | 
| The difference in tear breakup time (TBUT) before and after treatment with Cequa. | Reduced tear break up time (TBUT) ≤ 10 seconds. | Four Weeks |