Phase 3
Completed N=242
A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT02553772 ↗
Enrolled (actual)
242
Serious AEs
0.8%
Results posted
Nov 2017
Primary outcomePrimary: Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score — 41.12; 39.63; -15.61; -13.16 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score |
41.12; 39.63; -15.61; -13.16 | — |
| SECONDARY Change From Baseline in Tear Break-up Time (TBUT) |
4.77; 4.93; 1.12; 1.34 | — |
| SECONDARY Change From Baseline in Corneal Staining Score |
4.49; 4.51; -1.49; -0.58 | — |
| SECONDARY Change From Baseline in Conjunctival Staining Score |
6.73; 5.87; -1.76; -1.18 | — |
| SECONDARY Change From Baseline in the Schirmer Test |
9.91; 9.85; 1.40; 1.38 | — |
Eligibility Criteria
Inclusion Criteria
- Used artificial tears for dry eye
- Visual acuity of at least 20/32 (while wearing glasses, if necessary).
Exclusion Criteria
- Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
- Herpes keratitis in the last 6 months
- Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
Data sourced from ClinicalTrials.gov (NCT02553772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.