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NCT01833117
A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye
NA trial testing FID 119515A in Dry Eye in 75 participants. Completed in 1 June 2013.
1 June 2013
Quick facts
| Lead sponsor | Alcon Research |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 1 May 2013 |
| Primary completion | 1 June 2013 |
| Estimated completion | 1 June 2013 |
Drugs / interventions tested
- FID 119515A
- Blink® Tears
Conditions studied
- Dry Eye — all drugs for Dry Eye →
Sponsor
Alcon Research — full company profile →
Who can join
18 and older, any sex, with Dry Eye. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes
Time frame: Baseline, 60 minutes
Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minut
Sponsor's own description
The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01833117
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Alcon Research trials
Trials by the same sponsor.
- NCT06884202 — Evaluation of Delefilcon A Contact Lenses · NA · completed
- NCT06784063 — Visual Performance With Clareon® Vivity® Intraocular Lenses (IOLs) · NA · completed
- NCT06571656 — Evaluation of the Safety and Tolerability of Ocular Lubricants · NA · terminated
- NCT06660290 — A Study to Evaluate 0.003% AR-15512 Safety and Drop Attributes · Phase 3 · completed
- NCT06483113 — DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study · terminated
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 NCT01833117 (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 Alcon Research
- Last refreshed: 31 May 2018
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/NCT01833117.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing