Dry EyePhase 4NCT00909324

Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery

A Phase 4 study testing Pre-LASIK 0.3% hypromellose and Post-LASIK 0.3% hypromellose in people with Dry Eye, run by Novartis Pharmaceuticals at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant). Read more about this study

Who is it for?: Ages 21 to 35 years
Conditions the study is for: Dry Eye
What is being tested?: Pre-LASIK 0.3% hypromellose and Post-LASIK 0.3% hypromellose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 1 siteIndia
Study dates: 1 Aug 2009to 1 Jan 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age 21 - 35
Both sexes
Seeking LASIK surgery at the Refractive Surgery Centre
Meeting all established criteria for appropriateness for LASIK established by the treating center

Who cannot join

Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus
Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment
Anticipated refusal or inability to undergo planned post-operative visits or assessment
Failure to meet all established criteria for appropriateness for LASIK

Trial locations and contacts

1 site in 1 country.

India1 site

Novartis Investigative Site
Delhi, 110088

Other trials in India

About this study

Official title: Efficacy, Tolerability and Comfort of 0.3% Hypromellose Eyedrops in the Pre- and Post-Operative Treatment of Patients Undergoing LASIK Surgery

Conditions: Dry Eye
Being tested: Pre-LASIK 0.3% hypromellose, Post-LASIK 0.3% hypromellose
Keywords: Post LASIK dry eye, Pre LASIK dry eye, Hypromellose
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pre-LASIK 0.3% hypromelloseDrug
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
Post-LASIK 0.3% hypromelloseDrug
Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.

Study groups in NCT00909324
Study group	Role	What they receive
Pre-LASIK 0.3% hypromellose	Experimental	Not described Receives: Drug: Pre-LASIK 0.3% hypromellose
Post-LASIK 0.3% hypromellose	Active comparator	Not described Receives: Drug: Post-LASIK 0.3% hypromellose

What is being measured

The primary outcome is the main question the study is designed to answer.

Ocular Comfort Level From Baseline to End of Study
Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.
Measured: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery

Secondary outcomes (2)

Tear Breakup Time From Baseline to End of Study
The time required for dry spots to appear on the corneal surface after blinking. Sodium fluorescein dye is added to the eye and the tear film is observed under a slit lamp while the patient avoids blinking until tiny dry spots develop. The longer it takes, the more stable the tear film. A short tear breakup time is a sign of a poor tear film. Generally, >10 seconds is thought to be normal, 5 to 10 seconds marginal, and <5 seconds low (with high likelihood of dry eye symptoms), ie, a shorter time indicates greater eye dryness. A positive change score indicates improvement.
Measured: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Results of Schirmer's Test From Baseline to End of Study
Schirmer's test determines tear production, and whether the eye produces enough tears to keep it moist. A small strip of filter paper is inserted inside the lower eyelid of each eye and the eyes are closed for 5 minutes. The paper is then removed and the length of paper that is moist is measured. A young person normally moistens 15 mm of the paper. The shorter the length of moist paper, the dryer the eyes. A positive change score indicates improvement.
Measured: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20091 Jan 2010

First posted28 May 2009 (estimated)
Study start1 Aug 2009
Primary completion1 Jan 2010
Study completion1 Jan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry EyeStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00909324
Sponsor's protocol ID: CGET980AIN03
Status last verified: Jul 2020
First submitted: 26 May 2009
Last updated: 17 Aug 2020
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy, Tolerability and Comfort of 0.3% Hypromellose Eyedrops in the Pre- and Post-Operative Treatment of Patients Undergoing LASIK Surgery
ClinicalTrials.gov ID: NCT00909324
Acronym / sponsor ID: CGET980AIN03
Conditions: Dry Eye
Keywords: Post LASIK dry eye, Pre LASIK dry eye, Hypromellose
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 1 Aug 2009 (actual)
Primary completion: 1 Jan 2010 (actual)
Study completion: 1 Jan 2010 (actual)
First posted: 28 May 2009 (estimated)
Results: Posted 24 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pre-LASIK 0.3% hypromellose	Experimental	Drug: Pre-LASIK 0.3% hypromellose
Post-LASIK 0.3% hypromellose	Active comparator	Drug: Post-LASIK 0.3% hypromellose

Who may qualify

Ages: 21 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age 21 - 35
Both sexes
Seeking LASIK surgery at the Refractive Surgery Centre
Meeting all established criteria for appropriateness for LASIK established by the treating center

Key exclusion criteria (5 listed)

Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus
Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment
Anticipated refusal or inability to undergo planned post-operative visits or assessment
Failure to meet all established criteria for appropriateness for LASIK

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pre-LASIK 0.3% hypromellosePatients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.	Drug	Pre-LASIK 0.3% hypromellose
Post-LASIK 0.3% hypromellosePatients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.	Drug	Post-LASIK 0.3% hypromellose

Primary outcome

Ocular Comfort Level From Baseline to End of Study
Time frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Patients rated their ocular comfort on a scale of 0 to 10 on the following parameters: Burning sensation, foreign body sensation, itching, watering of eyes, dryness of eyes, and photophobia. A higher score indicated greater discomfort. A negative change score indicated improvement.

2 secondary outcomes

Tear Breakup Time From Baseline to End of Study
Time frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery
Results of Schirmer's Test From Baseline to End of Study
Time frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery

Results and safety

Results posted to the registry on 24 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pre-LASIK 0.3% Hypromellose	72	72
Post-LASIK 0.3% Hypromellose	90	90

Primary outcome: Ocular Comfort Level From Baseline to End of Study

Time frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery. Mean (Standard Deviation). Unit: Units on a scale

Measure	Pre-LASIK 0.3% Hypromellose n = 72	Post-LASIK 0.3% Hypromellose n = 90
Burning in eyes: Post-LASIK Day 1	0.68 (1.18)	0.84 (1.16)
Burning in eyes: Day 7	0.24 (0.52)	0.31 (0.54)
Burning in eyes: Day 30	0.08 (0.33)	0.07 (0.26)
Foreign body sensation: Post-LASIK Day 1	0.94 (1.47)	1.09 (1.41)
Foreign body sensation: Day 7	0.26 (0.56)	0.27 (0.55)
Foreign body sensation: Day 30	0.05 (0.29)	0.09 (0.33)
Itching: Post-LASIK Day 1	0.35 (0.77)	0.71 (1.21)
Itching: Day 7	0.16 (0.48)	0.32 (0.68)

Population analysed: Intent-to-Treat population: All patients in the study who received study treatment.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-LASIK 0.3% Hypromellose	0 of 72 (0%)	0 of 72 (0%)	Not reported
Post-LASIK 0.3% Hypromellose	0 of 90 (0%)	0 of 90 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

Novartis India Ltd. study director

Novartis India Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pre-LASIK 0.3% hypromellose and Post-LASIK 0.3% hypromellose in people with Dry Eye, run by Novartis Pharmaceuticals at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular Comfort Level From Baseline to End of Study (time frame: Baseline (Pre-LASIK surgery), Day 1, Day 7 and Day 30 post-LASIK surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00909324.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.