Dry Eye SyndromesPhase 4NCT04342988
Effect of Cequa Treatment on Accuracy of Pre-operative Biometry & Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery
A Phase 4 study testing Cequa in people with Dry Eye Syndromes, run by Research Insight LLC at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Cequa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Apr 2020to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ophthalmic Surgeons & Consultants of Ohio
Columbus, Ohio, 43215
Harvard Eye Associates
Laguna Hills, California, 92653
Ophthalmology Associates
St Louis, Missouri, 63131
About this study
Official title: Effect of Cequa Treatment on Accuracy of Pre-operative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery
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.
- Conditions
- Dry Eye Syndromes
- Being tested
- Cequa
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CequaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cequa Treatment In Cataract Patients with Dry Eye Disease | Other | 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. Receives: Drug: Cequa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.
Measured: Four weeks
Secondary outcomes (4)
The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.
Measured: 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.
Measured: 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.
Measured: Four Weeks
The difference in tear breakup time (TBUT) before and after treatment with Cequa.
Reduced tear break up time (TBUT) ≤ 10 seconds.
Measured: Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start8 Apr 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Insight LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Hovanesian, MD, Study director, Research Insight LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342988
- Sponsor's protocol ID
- Sun Cequa Accuracy 191118
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2020
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
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 17102664Geerling 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cequa Treatment on Accuracy of Pre-operative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT04342988
- Acronym / sponsor ID
- Sun Cequa Accuracy 191118
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Research Insight LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cequa Treatment In Cataract Patients with Dry Eye Disease | Other | Drug: CequaDuration 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CequaThe 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. | Drug | Cequa Treatment In Cataract Patients with Dry Eye Disease |
Primary outcome
Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.
Time frame: Four weeks
4 secondary outcomes
The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.
Time frame: Four Weeks
The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment.
Time frame: Four Weeks
The difference in corneal staining before and after treatment with Cequa.
Time frame: Four Weeks
The difference in tear breakup time (TBUT) before and after treatment with Cequa.
Time frame: Four Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Background: PubMed 17102664Behrens 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.
- Background: PubMed 21450919Geerling 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.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hovanesian, MD study director
Research Insight LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cequa in people with Dry Eye Syndromes, run by Research Insight LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery. (time frame: Four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04342988, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.