NCT02363530: CPUDCS

Influence of 2% HPMC Used During Cataract Surgery for Intraoperative Corneal Optical Clarity and Post-operation Xerophthalmia.

Status unknown NA Last updated 19 November 2015

What this trial tests

NA trial testing Hydroxypropyl ethylcellulose (HPMC) 2% gel in Cataract in 100 participants. Status unknown.

Timeline

1 November 2014

Primary endpoint
1 December 2015

1 December 2015

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	100
Start date	1 November 2014
Primary completion	1 December 2015
Estimated completion	1 December 2015
Sites	1 location across China

Drugs / interventions tested

• Hydroxypropyl ethylcellulose (HPMC) 2% gel
• BSS (SODIUM CITRATE) — full drug profile →

Conditions studied

• Cataract — all drugs for Cataract →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 40 to 85, any sex, with Cataract. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• change from baseline dry eye condition at 1 month
  Time frame: an expected average of a month after the surgery
  Dry eye condition includes tear break up time (TBUT), height of the river of tears,Schirmer Ⅰ test,ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire.
• Intraoperative corneal clarity
  Time frame: during the surgery
  record the times of using HPMC or BSS during the surgery to maintain the intraoperative corneal clarity and how long it lasts.
• change from baseline corneal damage at 1 month
  Time frame: an expected average of a month after the surgery
  Corneal damage evaluated by fluorescence staining of cornea

Sponsor's own description

This randomized controlled subject- and examiner-masked study comprised patients scheduled for cataract surgery.The patients will be randomly assigned to receive either balanced salt solution（BSS）or hydroxypropyl methylcellulose（HPMC）2% gel （Cornea Protect）.Each subject should undertake examination including - rupture time (TBUT), height of the river of tears, fluorescence staining, Schirmer Ⅰ test, ocular surface disease index (OSDI) and self-conscious symptom assessment questionnaire for assessment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cellulosic Polymers for Enhancing Drug Bioavailability in Ocular Drug Delivery Systems.
   Gupta B, Mishra V, Gharat S, Momin M, et al · · 2021 · cited 53× · PMID 34832983 · DOI 10.3390/ph14111201