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CompletedNCT04342988Updated Mar 12, 2021

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

A Phase 4 interventional study of Cequa in Dry Eye Syndromes, sponsored by Research Insight LLC. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-12.

Sponsored by Research Insight LLC · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Dec 2020, 5 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 4
Study type
Interventional
Enrollment
74
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dry Eye Syndromes
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 74 is close to the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Research Insight LLC is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • Other
    Cequa Treatment In Cataract Patients with Dry Eye Disease

    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

Interventions

  • DrugCequa

    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.

06

What researchers measure

Primary outcomes

  1. Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.

    Time frame: Four weeks

Secondary outcomes

  1. The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.

    Time frame: Four Weeks

  2. 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.

    Time frame: Four Weeks

  3. 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.

    Time frame: Four Weeks

  4. The difference in tear breakup time (TBUT) before and after treatment with Cequa.

    Reduced tear break up time (TBUT) ≤ 10 seconds.

    Time frame: Four Weeks

07

Study locations

3 sites
  • Harvard Eye Associates
    Laguna Hills, California 92653, United States
  • Ophthalmology Associates
    Saint Louis, Missouri 63131, United States
  • Ophthalmic Surgeons & Consultants of Ohio
    Columbus, Ohio 43215, United States
08

References and documents

Publications

  • 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. PubMed 17102664 ↗
  • 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. PubMed 21450919 ↗

Individual participant data

Plan to share: No — 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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04342988
Lead sponsor
Research Insight LLC
Responsible party
Sponsor
First posted
Apr 13, 2020
Start date
Apr 8, 2020
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020
Last update
Mar 12, 2021

Study contacts

John Hovanesian, MD
study director · Research Insight LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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