Phase 3
Completed N=188
A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT02280473 ↗
Enrolled (actual)
188
Serious AEs
0.5%
Results posted
Jun 2017
Primary outcomePrimary: Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score — 42.44; 40.43; -10.29; -7.48 Scores 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 This can indicate results are unpublished — a known publication-bias signal.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 o fRefresh Optive® Gel Drops in patients with dry eye disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score |
42.44; 40.43; -10.29; -7.48 | — |
| SECONDARY Change From Baseline in the OSDI© Score |
42.44; 40.43; -5.74; -2.34 | — |
| SECONDARY Change From Baseline in Tear Break-up Time (TBUT) |
5.38; 5.40; 0.84; 0.70 | — |
| SECONDARY Change From Baseline in the Combined Corneal and Conjunctival Staining Scores |
10.9; 11.8; -1.7; -2.0 | — |
| SECONDARY Change From Baseline in the Schirmer Test |
9.98; 11.32; 0.89; 0.69 | — |
Eligibility Criteria
Inclusion Criteria
- Current use of an artificial tear product
- 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
- Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months
- Current eye infection or inflammation
Data sourced from ClinicalTrials.gov (NCT02280473). 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.