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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04342988
• Other study ID #: Sun Cequa Accuracy 191118
• Status: Completed
• Phase: Phase 4
• Start date: April 8, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2020
• Source: Research Insight LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Cequa
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.

Locations

Country	Name	City	State
United States	Ophthalmic Surgeons & Consultants of Ohio	Columbus	Ohio
United States	Harvard Eye Associates	Laguna Hills	California
United States	Ophthalmology Associates	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Research Insight LLC

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.		Four weeks
Secondary	The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.		Four Weeks
Secondary	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
Secondary	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
Secondary	The difference in tear breakup time (TBUT) before and after treatment with Cequa.	Reduced tear break up time (TBUT) = 10 seconds.	Four Weeks