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NCT05990712
The Effect of a Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers
Phase 4 trial testing Omega-3 in Dry Eye in 68 participants. Status unknown.
1 January 2024
Quick facts
| Lead sponsor | Uptown Eye Specialists |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 68 |
| Start date | 1 September 2023 |
| Primary completion | 1 January 2024 |
| Estimated completion | 1 January 2024 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Omega-3
- Trehalose — full drug profile →
- Zocular Eyelid System Treatment — full drug profile →
- Blephadex cleansing eyelid wipes
Conditions studied
- Dry Eye — all drugs for Dry Eye →
- Dry Eye Syndromes — all drugs for Dry Eye Syndromes →
- Cataract — all drugs for Cataract →
Sponsor
Uptown Eye Specialists — full company profile →
Who can join
18 and older, any sex, with Dry Eye or Dry Eye Syndromes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study assesses the impact of two differing ocular hygiene regimens prior to cataract surgery. The first regimen includes an omega-3 supplement and the second without, and both include an at-home lid wipe and cleansing eye drops. These regimens will be assessed on microbial load, inflammation, tear osmolarity, and dry eye metrics. Patients will be randomized to either the omega-3 group + 3-part hygiene regimen, or the group with only the 3-part hygiene regimen. Data will be collected for inflammation through a test (InflammaDry) that measures an inflammatory marker, dry eye metrics via an imaging tool called Oculus 5M and the Canadian Dry Eye Assessment (CDEA) questionnaire, tear osmolarity through Tear Labs device, and area of growth for conjunctiva microbial load by swabbing the conjunctiva of the eye. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load swabs will be collected at baseline, 2-5 days prior to surgery, and date of the surgery. An ocular assessment will also be completed at baseline, one week post-operation, and one month post-operation. All metrics will be compared to the fellow eye. The usage of omega-3 will be compared to the regimen without omega-3.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05990712
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Dry Eye
Currently open trials in the same condition.
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- NCT07329712 — Comparing Tear Proteomics Profile in Dry Eye Disease pre-and Post-treatment With Low Level Light Therapy · recruiting
- NCT07266948 — Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work · Phase 4 · recruiting
- NCT07298811 — Preliminary Clinical Study of the Effectiveness and Safety of Ocular Surface Microbiota Transplantation in the Treatment · Phase 1, PHASE2 · recruiting
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Other Uptown Eye Specialists trials
Trials by the same sponsor.
- NCT05766722 — Feasibility of an Artificial Intelligence Phone Call After Cataract Surgery · NA · unknown
- NCT05480839 — Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential B · NA · unknown
- NCT04856670 — Assessing Diabetes Mellitus on Cytokine Analysis and Macular Edema Following FLACS · unknown
- NCT04856397 — Ozurdex in Suboptimal Diabetic Macular Edema Patients · NA · unknown
- NCT04623229 — A Comparison of Patient Perceptions Undergoing Manual Cataract Surgery (MCS) vs Refractive Laser-assisted Cataract Surge · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05990712 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Uptown Eye Specialists
- Last refreshed: 14 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05990712.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing