Dry Eye SyndromesPhase 4NCT04184999
Effect of Intraoperative Dexamethasone on Post-op Dry Eye
A Phase 4 study testing dexamethasone intraocular suspension, 9% and Prednisolone Acetate 1% Oph Susp in people with Dry Eye Syndromes, run by SR Cornea Consultants at 1 site in United States.
Trial summary
To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- dexamethasone intraocular suspension, 9% and Prednisolone Acetate 1% Oph Susp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2019to 1 Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing bilateral cataract surgery
Who cannot join
- central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye
Trial locations and contacts
1 site in 1 country.
United States1 site
Hauser Ross Surgical Center
Sycamore, Illinois, 60178
About this study
Official title: Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye
To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.
Read the detailed description
Forty patients requiring cataract surgery will be randomized to treatment of post-operative inflammation with a single intraoperative dexamethasone injection plus a standard course of topical ophthalmic corticosteroid drops or the standard treatment alone. Dry eye testing will be administered at baseline, 1 week and 3 weeks following surgery.
- Conditions
- Dry Eye Syndromes
- Being tested
- dexamethasone intraocular suspension, 9%, Prednisolone Acetate 1% Oph Susp
- 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.
dexamethasone intraocular suspension, 9%Drug
Also called Dexycu
single dose intracameral corticosteroid
Prednisolone Acetate 1% Oph SuspDrug
topical ophthalmic steroid drop
| Study group | Role | What they receive |
|---|---|---|
| Intracameral dexamethasone 9% + postoperative topical prednisolone acetate | Experimental | dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively Receives: Drug: dexamethasone intraocular suspension, 9%; Drug: Prednisolone Acetate 1% Oph Susp |
| postoperative topical prednisolone acetate | Active comparator | topical ophthalmic prednisolone acetate for 3 weeks post-operatively Receives: Drug: Prednisolone Acetate 1% Oph Susp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start10 Aug 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled prospective study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- SR Cornea Consultants
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay N Rao, MD, SR Cornea Consultants
- Investigators
- Sanjay Rao, MD, Principal investigator, SR Cornea Conslutants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184999
- Sponsor's protocol ID
- SRCC10
- Status last verified
- Nov 2023
- First submitted
- 1 Dec 2019
- Last updated
- 22 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye
- ClinicalTrials.gov ID
- NCT04184999
- Acronym / sponsor ID
- SRCC10
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SR Cornea ConsultantsUniversity, hospital or other
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 4 Dec 2019 (actual)
- Results
- Posted 29 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.
Detailed description
Forty patients requiring cataract surgery will be randomized to treatment of post-operative inflammation with a single intraoperative dexamethasone injection plus a standard course of topical ophthalmic corticosteroid drops or the standard treatment alone. Dry eye testing will be administered at baseline, 1 week and 3 weeks following surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, controlled prospective study.
| Arm | Type | Receives |
|---|---|---|
| Intracameral dexamethasone 9% + postoperative topical prednisolone acetate | Experimental | Drug: dexamethasone intraocular suspension, 9%, Drug: Prednisolone Acetate 1% Oph Suspdexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively |
| postoperative topical prednisolone acetate | Active comparator | Drug: Prednisolone Acetate 1% Oph Susptopical ophthalmic prednisolone acetate for 3 weeks post-operatively |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing bilateral cataract surgery
Key exclusion criteria (1 listed)
- central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye
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 |
|---|---|---|
| dexamethasone intraocular suspension, 9%Also: Dexycusingle dose intracameral corticosteroid | Drug | Intracameral dexamethasone 9% + postoperative topical prednisolone acetate |
| Prednisolone Acetate 1% Oph Susptopical ophthalmic steroid drop | Drug | Intracameral dexamethasone 9% + postoperative topical prednisolone acetate, postoperative topical prednisolone acetate |
Primary outcome
Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
Time frame: 3 weeks
Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sanjay Rao, MD principal investigator
SR Cornea Conslutants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexamethasone intraocular suspension, 9% and Prednisolone Acetate 1% Oph Susp in people with Dry Eye Syndromes, run by SR Cornea Consultants at 1 site 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 1 inclusion and 1 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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 29 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2023.