Abstract
Purpose: To evaluate and compare the efficacy of a lipid-based lubricant eyedrop formulation (hydroxypropyl guar/propylene glycol/phospholipid [HPG/PG/PL]) with preservative-free saline for the treatment of dry eye. Methods: This was a prospective, multicenter, randomized, single-masked, parallel-group phase 4 clinical study. Patients ≥18 years diagnosed with dry eye received 1 drop of saline 4 times daily (QID) for 15 days during a run-in phase, followed by randomization. Patients then instilled HPG/PG/PL or saline QID through day 35 and as needed through day 90. Change in tear film break-up time (TFBUT), change in total ocular surface staining (TOSS) score, and Impact of Dry Eye on Everyday Life (IDEEL) were evaluated on day 35. Results: Increase in TFBUT from baseline to day 35 was assessed during the interim and final analyses. Mean ± SE difference between the HPG/PG/PL (n = 110) and saline groups (n = 100) was 1.3 ± 0.4 seconds (interim analysis; 95% confidence interval [CI] 0.5-2.1 seconds; p = 0.0012) and 1.0 ± 0.3 seconds (final analysis; 95% CI 0.4-1.6 seconds; p = 0.0011), demonstrating the superiority of HPG/PG/PL. The mean ± SE difference between the HPG/PG/PL and saline groups for IDEEL treatment effectiveness scores was 16.0 ± 3.6 (95% CI 8.9-23.1; p<0.0001). No significant differences in TOSS scores or IDEEL inconvenience scores were observed between treatment groups. Conclusions: Thirty-five days of QID HPG/PG/PL treatment resulted in a statistically significant improvement in TFBUT and IDEEL treatment effectiveness scores compared with saline but not in TOSS or IDEEL treatment inconvenience scores. HPG/PG/PL was well-tolerated by patients.
| Original language | English |
|---|---|
| Pages (from-to) | 122-128 |
| Number of pages | 7 |
| Journal | European Journal of Ophthalmology |
| Volume | 27 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - Mar 1 2017 |
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Keywords
- Hydroxypropyl guar
- Ocular surface staining
- Propylene glycol
- Quality of life
- Systane Balance
- Tear film break-up time
ASJC Scopus subject areas
- Medicine(all)
- Ophthalmology
Cite this
Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency. / Baudouin, Christophe; Galarreta, David J.; Mrukwa-Kominek, Ewa; Böhringer, Daniel; Maurino, Vincenzo; Guillon, Michel; Rossi, Gemma C.M.; Van der Meulen, Ivanka J.; Ogundele, Abayomi; Labetoulle, Marc.
In: European Journal of Ophthalmology, Vol. 27, No. 2, 01.03.2017, p. 122-128.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Clinical evaluation of an oil-based lubricant eyedrop in dry eye patients with lipid deficiency
AU - Baudouin, Christophe
AU - Galarreta, David J.
AU - Mrukwa-Kominek, Ewa
AU - Böhringer, Daniel
AU - Maurino, Vincenzo
AU - Guillon, Michel
AU - Rossi, Gemma C.M.
AU - Van der Meulen, Ivanka J.
AU - Ogundele, Abayomi
AU - Labetoulle, Marc
PY - 2017/3/1
Y1 - 2017/3/1
N2 - Purpose: To evaluate and compare the efficacy of a lipid-based lubricant eyedrop formulation (hydroxypropyl guar/propylene glycol/phospholipid [HPG/PG/PL]) with preservative-free saline for the treatment of dry eye. Methods: This was a prospective, multicenter, randomized, single-masked, parallel-group phase 4 clinical study. Patients ≥18 years diagnosed with dry eye received 1 drop of saline 4 times daily (QID) for 15 days during a run-in phase, followed by randomization. Patients then instilled HPG/PG/PL or saline QID through day 35 and as needed through day 90. Change in tear film break-up time (TFBUT), change in total ocular surface staining (TOSS) score, and Impact of Dry Eye on Everyday Life (IDEEL) were evaluated on day 35. Results: Increase in TFBUT from baseline to day 35 was assessed during the interim and final analyses. Mean ± SE difference between the HPG/PG/PL (n = 110) and saline groups (n = 100) was 1.3 ± 0.4 seconds (interim analysis; 95% confidence interval [CI] 0.5-2.1 seconds; p = 0.0012) and 1.0 ± 0.3 seconds (final analysis; 95% CI 0.4-1.6 seconds; p = 0.0011), demonstrating the superiority of HPG/PG/PL. The mean ± SE difference between the HPG/PG/PL and saline groups for IDEEL treatment effectiveness scores was 16.0 ± 3.6 (95% CI 8.9-23.1; p<0.0001). No significant differences in TOSS scores or IDEEL inconvenience scores were observed between treatment groups. Conclusions: Thirty-five days of QID HPG/PG/PL treatment resulted in a statistically significant improvement in TFBUT and IDEEL treatment effectiveness scores compared with saline but not in TOSS or IDEEL treatment inconvenience scores. HPG/PG/PL was well-tolerated by patients.
AB - Purpose: To evaluate and compare the efficacy of a lipid-based lubricant eyedrop formulation (hydroxypropyl guar/propylene glycol/phospholipid [HPG/PG/PL]) with preservative-free saline for the treatment of dry eye. Methods: This was a prospective, multicenter, randomized, single-masked, parallel-group phase 4 clinical study. Patients ≥18 years diagnosed with dry eye received 1 drop of saline 4 times daily (QID) for 15 days during a run-in phase, followed by randomization. Patients then instilled HPG/PG/PL or saline QID through day 35 and as needed through day 90. Change in tear film break-up time (TFBUT), change in total ocular surface staining (TOSS) score, and Impact of Dry Eye on Everyday Life (IDEEL) were evaluated on day 35. Results: Increase in TFBUT from baseline to day 35 was assessed during the interim and final analyses. Mean ± SE difference between the HPG/PG/PL (n = 110) and saline groups (n = 100) was 1.3 ± 0.4 seconds (interim analysis; 95% confidence interval [CI] 0.5-2.1 seconds; p = 0.0012) and 1.0 ± 0.3 seconds (final analysis; 95% CI 0.4-1.6 seconds; p = 0.0011), demonstrating the superiority of HPG/PG/PL. The mean ± SE difference between the HPG/PG/PL and saline groups for IDEEL treatment effectiveness scores was 16.0 ± 3.6 (95% CI 8.9-23.1; p<0.0001). No significant differences in TOSS scores or IDEEL inconvenience scores were observed between treatment groups. Conclusions: Thirty-five days of QID HPG/PG/PL treatment resulted in a statistically significant improvement in TFBUT and IDEEL treatment effectiveness scores compared with saline but not in TOSS or IDEEL treatment inconvenience scores. HPG/PG/PL was well-tolerated by patients.
KW - Hydroxypropyl guar
KW - Ocular surface staining
KW - Propylene glycol
KW - Quality of life
KW - Systane Balance
KW - Tear film break-up time
UR - http://www.scopus.com/inward/record.url?scp=85015800386&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85015800386&partnerID=8YFLogxK
U2 - 10.5301/ejo.5000883
DO - 10.5301/ejo.5000883
M3 - Article
C2 - 27791253
AN - SCOPUS:85015800386
VL - 27
SP - 122
EP - 128
JO - European Journal of Ophthalmology
JF - European Journal of Ophthalmology
SN - 1120-6721
IS - 2
ER -