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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cequa
Sponsored by
Research Insight LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Harvard Eye Associates
  • Ophthalmology Associates
  • Ophthalmic Surgeons & Consultants of Ohio

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cequa Treatment In Cataract Patients with Dry Eye Disease

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
The difference in tear breakup time (TBUT) before and after treatment with Cequa.
Reduced tear break up time (TBUT) ≤ 10 seconds.

Full Information

First Posted
April 6, 2020
Last Updated
March 11, 2021
Sponsor
Research Insight LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04342988
Brief Title
Effect of Cequa Treatment on Accuracy of Pre-operative Biometry & Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery
Official Title
Effect of Cequa Treatment on Accuracy of Pre-operative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 8, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Insight LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cequa Treatment In Cataract Patients with Dry Eye Disease
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cequa
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.
Time Frame
Four Weeks
Title
The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment.
Description
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.
Time Frame
Four Weeks
Title
The difference in corneal staining before and after treatment with Cequa.
Description
The presence of central or inferior corneal fluorescein staining defined by the Oxford Scale.
Time Frame
Four Weeks
Title
The difference in tear breakup time (TBUT) before and after treatment with Cequa.
Description
Reduced tear break up time (TBUT) ≤ 10 seconds.
Time Frame
Four Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Hovanesian, MD
Organizational Affiliation
Research Insight LLC
Official's Role
Study Director
Facility Information:
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Ophthalmic Surgeons & Consultants of Ohio
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with, the Sponsor, and such that confidential or proprietary information is not disclosed
Citations:
PubMed Identifier
17102664
Citation
Behrens A, Doyle JJ, Stern L, Chuck RS, McDonnell PJ, Azar DT, Dua HS, Hom M, Karpecki PM, Laibson PR, Lemp MA, Meisler DM, Del Castillo JM, O'Brien TP, Pflugfelder SC, Rolando M, Schein OD, Seitz B, Tseng SC, van Setten G, Wilson SE, Yiu SC; Dysfunctional tear syndrome study group. Dysfunctional tear syndrome: a Delphi approach to treatment recommendations. Cornea. 2006 Sep;25(8):900-7. doi: 10.1097/01.ico.0000214802.40313.fa.
Results Reference
background
PubMed Identifier
21450919
Citation
Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available.
Results Reference
background

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

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